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An affordable <keyword id="9107118" type="General" weightage="20" keywordseo="tuberculosis-testing" source="Orion">tuberculosis testing</keyword> technology that can detect the disease using a patient's sputum for just Rs 35 has been developed by apex medical research body <keyword id="19918794" type="General" weightage="20" keywordseo="ICMR" source="keywords">ICMR</keyword>'s regional centre in Assam's Dibrugarh. The 'A <keyword id="19986036" type="General" weightage="20" keywordseo="CRISPR" source="keywords">CRISPR</keyword> case-based TB detection system' is light, portable and involves three steps of testing. Over 1,500 samples can be tested in one single run in around two-and-half hours, ICMR sources said. Conventional diagnostic techniques for TB commonly rely on culture, which requires 42 days to confirm as TB negative, microscopy, and nucleic acid-based methods. These are also time-consuming and may require sophisticated equipment. An official said, "<keyword id="19992404" type="General" weightage="100" keywordseo="Tuberculosis" source="keywords">Tuberculosis</keyword> (TB) remains a global health challenge, necessitating the development of accurate and rapid diagnostic tools for effective disease management. Current <keyword id="22921102" type="General" weightage="20" keywordseo="diagnostic-methods" source="keywords">diagnostic methods</keyword> often exhibit limitations in terms of sensitivity, specificity, speed and cost, emphasising the need for innovative approaches". Additionally, some molecular diagnostic methods, while offering improved sensitivity, may lack the desired specificity or face challenges associated with cost and ease of handling. "Considering these problems, the CRISPR-Cas12a-based molecular diagnostic system 'GlowTBPCRKit' coupled with an amplification step (using thermal cycler) and the '<keyword id="22921103" type="General" weightage="20" keywordseo="RapidGlow-device" source="keywords">RapidGlow device</keyword>' provides a promising solution," the official said. The Indian Council of Medical Research (ICMR) has now invited Expression of Interest (EoI) from eligible organisations, companies, manufacturers for undertaking 'Transfer of Technology' for commercialisation of the 'A CRISPR case-based TB detection system' for the detection of <keyword id="20115212" type="General" weightage="20" keywordseo="Mycobacterium-tuberculosis" source="keywords">Mycobacterium tuberculosis</keyword>. The ICMR-RMRCNE institute will provide expert guidance and technical support for the production of 'A CRISPR Cas based TB detection system' in all phases. Such technical oversight by the institute would accelerate the development of the product and its commercialisation. The ICMR would also provide technical support through its team of experienced scientists in study, planning, product development, development of study protocol, results or data analysis, outcome assessment, safety and efficacy assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company. The apex health research body through its institutes would provide support and facilitation to conduct the research and development or clinical study of new technology or product in India through its affiliates or institutes, in collaboration with the company and institutions in a professional and mutually agreed upon manner and timelines.

ICMR's regional centre develops technology that can test for tuberculosis in just Rupees 35!

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>We're getting a better idea of what information Theranos will be sharing about its blood-testing data.On August 1, Theranos CEO Elizabeth Holmes will be presenting data at the&#xa0;<a href="https://www.aacc.org/meetings-and-events/2016-annual-meeting-and-expo">American Association for Clinical Chemistry's annual conference</a>&#xa0;in Philadelphia.That's going to be a big deal because Theranos has not publicly shared any data, saying that it'd rather go through the FDA process. This will be the first time Theranos data has been presented at a medical conference.The AACC released the abstract of her presentation on Wednesday. Here are the biggest things we noticed:<ol><li>It's going to be an education session, which means that it's not pegged to specific study data and conclusions that a <a href="http://www.businessinsider.com/what-is-asco-2016-6?op=0#/#once-you-get-past-all-the-booths-there-are-posters-presenting-data-from-all-of-the-studies-accepted-to-the-conference-these-give-you-all-the-information-you-need-to-know-about-the-clinical-trials-including-how-they-were-run-what-happened-and-who-funded-them-its-an-overwhelming-amount-of-information-theyre-not-quite-as-flashy-as-the-booths-8">study poster presentation</a>&#xa0;would display.</li><li>It'll be presenting&#xa0;data that intends to show how the company's finger-prick blood test, which requires only a small amount of blood, stacks up to a typical blood test that draws a few tubes of blood from a vein.</li><li>Among the tests Theranos will be demonstrating is a test to diagnose the Zika virus.</li></ol><h2>Here's the abstract:</h2>Title: Theranos <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">Science</keyword> &amp; Technology: the miniaturization of lab testingAbstract: Theranos' mission is to deliver affordable and easily accessible clinical diagnostic testing. To achieve this objective, the company has developed a family of novel clinical diagnostic methods with the aim to simplify sample collection and reduce sample volume requirements, while performing a wide range of diagnostic tests in both centralized and decentralized settings. This presentation will describe the Theranos lab testing framework, which consists of a finger-stick blood collection and storage device, technologies for processing small volume samples in a centralized setting, and a compact fully-integrated and automated field-deployable diagnostic testing platform. Ms. Holmes will present reproducibility and correlation data for various tests comparing Theranos' capillary collection and storage device with traditional venipuncture methods. She will also discuss methodology employed for their diagnostic testing platform, and share data to demonstrate the precision and accuracy of these chemistry, immunochemistry, hematology, and molecular assays (traditionally performed on separate instruments) using their analytical testing platform, including a novel molecular test for the Zika virus.Following the presentation by Ms. Holmes, there will be a moderator-led Q&amp;A session featuring questions submitted in real-time by members of the audience. The moderator panel will include Drs. Patti Jones, PhD; Y.M. Dennis Lo, DM, DPhil, FRCP, FRCPath; and Stephen Master, MD, PhD. This interactive session is not part of the accredited educational program, and as such will not receive Continuing Medical Education or ACCENT credit.<a href="http://www.businessinsider.com/walgreens-cancels-theranos-partnership-2016-6">Walgreens on Sunday said that its relationship</a> with Theranos was over effective immediately. Walgreens cited the company's decision to void two years' worth of test results and a government agency's rejection of the company's plan of correction.The termination shutters an additional 40 Theranos Wellness Centers, where people can go have their blood drawn, in Walgreens stores.&#xa0;Any future partnerships from here on out will most likely rely on validating the company's technology, and this presentation in August could be critical to winning back some ground. <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/veinviewer-medical-device-2016-3">This medical device should make drawing blood a lot less painful </a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="swMDVpMTE6SJ5n-XvdKmO31ngJXeEGVM" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

Theranos is finally going to share data on its blood tests - here's what to expect

New York, Jul 4 () Researchers, led by an Indian scientist, have developed a cheap, electricity free centrifuge to separate components in patient saliva samples for the detection of the novel coronavirus, an advance that may increase accessibility of COVID-19 diagnostics in poor regions of the world. According to the scientists, including Manu Prakash from Stanford University in the US, the 'Handyfuge' device spins sample-containing tubes at very high speeds, enough to separate the virus genome from patient saliva samples, without needing electricity. They said the cheap centrifuge, described in a yet-to-be peer-reviewed study published in the platform medRxiv, can be assembled using readily available components for a cost less than five USD per unit. It can allow clinicians and scientists to carry out a quick and cheap diagnostic technique called the LAMP assay to detect the presence of the novel coronavirus genome in patient saliva samples, the scientists noted. The LAMP protocol, according to the researchers, "has the benefits of being simple, requiring no specialised equipment, rapid, requiring less than an hour from sample collection to readout, and cheap, costing around one dollar per reaction using commercial reagents." While the assay has these benefits, the scientists said there could be a variability in output in diagnostic methods based on viral genome detection in saliva samples. They explained that this is due to the saliva containing substances which can inhibit diagnostic reagents. "Centrifugation to separate the reaction inhibitors from inactivated sample was shown to be an effective way to ensure reliable LAMP amplification," the scientists wrote in the study. However, they said a centrifuge capable of safely achieving the necessary speeds of 2000 rotations per minute (RPM), for several minutes, costs hundreds of dollars, also requiring a power supply. With Handyfuge, this limitation can be over come, said Prakash -- a professor of Bioengineering at Stanford University, whose lab had earlier developed a cheap "origami microscope" called 'Foldscope'. The scientists explained that the novel device uses a mechanical strategy similar to the 'Dyno-torch' flashlights to generate centrifugal force using kinetic input from the user. "The user repeatedly squeezes the handle to spin a small freewheel connected to a centrifuge spindle," they wrote in the study. After a designated amount of time, enough centrifugal force is applied to the sample-containing tubes, the scientists said, yielding a separated liquid layer that is free of chemicals that may inhibit the coronavirus genetic material, its RNA. "This supernatant can then be reliably used for LAMP detection of SARS-CoV-2 or other viruses using the Rabe and Cepko assay," the researchers wrote. According to the study, the Handyfuge-LAMP assay works based on protocol for the diagnostic method developed by scientists, Brian Rabe and Constance Cepko, from Harvard University in the US. "This simple electricity-free LAMP protocol builds on fantastic work by Cepko lab at Harvard, but with a hand powered centrifuge to make this assay completely electricity free for resource constrained settings," Prakash's lab mentioned in a tweet. "The advantage for handyfuge is increased stability and limited fluctuations in RPM and it matches covid test need," the scientists noted on Twitter. According to the scientists, the idea started from a flash light picked up from a toy store, which they hacked to build Handyfuge. They then validated the performance of the device using the LAMP protocol from Rabe and Cepko. They said the Handyfuge, combined with the assay from Cepko and Rabe, works reliably in detecting synthetic COVID-19 RNA "down to 10-100 copies per microlitres in saliva." "With the use of insulated coolers for reagent supply chain and delivery, the assay presented can be completed without the need for electricity or any laboratory scale infrastructure," the study noted. However, to determine the effectiveness of the device as a point of care tool, the researchers said it will need to be validated with actual patient samples. "We are currently preparing to test this protocol and Handyfuge in field settings," they wrote in the study. VIS VIS

Indian-led team develops cheap, electricity free centrifuge for COVID-19 testing

Toronto, June 11 () Scientists have found that seven out of 27 COVID-19 diagnostic tests which are currently in use may be underperforming possibly due to the novel coronavirus mutating, and have cautioned that the effectiveness of testing methods needs to be re-evaluated. According to the study, published in the journal Royal Society Open Science, many of the tests were developed early in the outbreak when the virus was first identified, and its genetic material was sequenced. The researchers from York University in Canada said it is important to re-evaluate the methods periodically to ensure they still work. "COVID-19 tests use polymerase chain reaction (PCR) assays to diagnose the virus in patients, but if those assays are mismatched due to genetic variability in the viral genome, that raises the concern that the tests may not be detecting all the circulating variants of the virus and results could be inaccurate," explained Kashif Aziz Khan, corresponding author of the study. Correcting any mismatches between the assays and the coronavirus genome may help improve the sensitivity and accuracy of some of the diagnostic tests, the researchers said in a statement. According to the scientists, the early sequencing of the genetic material of the virus allowed for the development of PCR detection protocols by multiple national organizations that were published by the World Health Organization (WHO). These tests, according to the study, use probes that bind to the viral genetic material in a patient sample and help produce several detectable copies of it -- if the person is infected with the coronavirus. However, the researchers said these tests that do not account for variations and mutations. "Given the potential for the viruses to mutate, genetic variations in the viral genome at primer/probe binding regions can result in potential mismatches and false-negative results," the scientists wrote in the study. In the current study, the researchers tested genetic variations in more than 17,000 publicly available viral genome sequences worldwide, and performed an exhaustive evaluation of 27 published diagnostic PCR assays. The analysis showed the presence of mismatches in the probe binding regions of the coronavirus genetic material in seven out of the 27 assays. "These findings are potentially important for clinicians, laboratory professionals and policy-makers as it gives them a better idea of which tests may deliver the best results, and how to ensure the tests they are using are properly matched to the virus genome," Khan said. VIS VIS

Coronavirus mutations may lead to COVID-19 diagnosis test mismatch: Study

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>Theranos has a lot to prove.And on August 1, Theranos CEO Elizabeth Holmes will have a chance at some redemption. She is presenting data on the company's controversial "revolutionary" tests that take only a finger-prick's worth of blood. That's happening at the <a href="https://www.aacc.org/meetings-and-events/2016-annual-meeting-and-expo">American Association for Clinical Chemistry's annual conference</a> in Philadelphia.Theranos has never publicly shared any its data before, saying for a long time that it'd rather go through the FDA approval process. This will be the first time Theranos data has been presented at a medical conference.Holmes is talking now because Theranos has faced withering criticism - ranging from reports that it tests don't actually work to a government shutdown of one of its labs - for almost a year.Even so, it might not be the data that puts the company back in good graces, lab-testing experts told Business Insider.<h2>Here's what's in store, according to the presentation's abstract:</h2><ul><li>It's going to be an education session, which means that it's not pegged to specific study data and conclusions that a <a href="http://www.businessinsider.com/what-is-asco-2016-6?op=0#/#once-you-get-past-all-the-booths-there-are-posters-presenting-data-from-all-of-the-studies-accepted-to-the-conference-these-give-you-all-the-information-you-need-to-know-about-the-clinical-trials-including-how-they-were-run-what-happened-and-who-funded-them-its-an-overwhelming-amount-of-information-theyre-not-quite-as-flashy-as-the-booths-8">study-poster presentation</a> would display. This also means that there won't be independently validated data.</li><li>Theranos will be presenting data that intends to show how the company's finger-prick blood test, which requires only a small amount of blood, stacks up to a typical blood test that draws a few tubes of blood from a vein.</li><li>Among the tests Theranos will be demonstrating is a test to diagnose the Zika virus.</li></ul>But that information is essentially "useless," since it's still not validated by independent reviewers, Dr. Eleftherios P. Diamandis, head of clinical biochemistry at Mount Sinai Hospital in Toronto, told Business Insider. Diamandis, who has <a href="http://www.businessinsider.com/scientist-skeptical-thranos-blood-test-elizabeth-holmes-2015-6">written critiques of Theranos</a> in the past, said it's all just speculative. That's because it won't be independently validated data from a large amount of test samples. Ideally, Diamandis said, Theranos would need to present millions of tests, with very rare failures. "The quality demands are going to be very high," he said.Diamandis, who's been going to this conference for decades, said he will be attending the presentation, but he's not going to be taught anything about the technology. He's mainly just curious to see what Holmes ends up sharing.<h2>A rocky July</h2>A year ago, Theranos was <a href="http://www.businessinsider.com/theranos-gets-fda-approval-2015-7">touting its first FDA approval</a> for a herpes test that could be run with just a few drops of blood. This July, the Centers for Medicare and Medicaid, which regulates blood-testing labs, barred Holmes from the industry for two years, imposing other sanctions including banning the company from working with the Medicare program.Theranos is now in the middle of a number of government investigations, including one by a <a href="https://democrats-energycommerce.house.gov/newsroom/press-releases/democratic-committee-leaders-request-information-from-fda-and-cms-on">congressional committee</a>. It's seen major deals fall apart, and now operates just five testing centers, down from more than 40.The company has taken steps to make things right, adding scientists to its newly formed <a href="http://www.businessinsider.com/theranos-adds-members-to-scientific-and-medical-advisory-board-2016-4">Scientific and Medical Advisory Board</a> - among those four former AACC presidents - and hiring <a href="http://www.businessinsider.com/theranos-adds-new-regulatory-positions-2016-7">compliance and regulatory executives</a>.<h2>Best-case scenario</h2>Ideally, if Theranos was able to show independently reviewed data, that would be the best way to make a comeback. But in the meantime, Howard Forman, Yale diagnostic radiology, economics, and public-health professor, told Business Insider that just having the company show a willingness to work with the government better would be a step in the right direction."I think it would be great if they could show willingness to change whatever management needs to be changed in order to have the relationships they need to be able to rebuild with CMS and CLIA," he said. But beyond that, the company will need to tackle the more serious issue of allowing university researchers to use its technology and run tests without any interference.Overall, there seems to be a optimism in seeing at least something. If the product works the way Theranos claims it does, it would have a huge impact on healthcare, Forman said."In the long run, we're all better by seeing new entities succeed, not to see them fail," he said. "But at the same time it has to be on terms that are going to make this country better and not just something that sops up venture money and never returns it to investors in a meaningful way."<h2>Here's the full abstract of Monday's presentation:</h2>Title: Theranos <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">Science</keyword> &amp; Technology: the miniaturization of lab testingAbstract: Theranos' mission is to deliver affordable and easily accessible clinical diagnostic testing. To achieve this objective, the company has developed a family of novel clinical diagnostic methods with the aim to simplify sample collection and reduce sample volume requirements, while performing a wide range of diagnostic tests in both centralized and decentralized settings. This presentation will describe the Theranos lab testing framework, which consists of a finger-stick blood collection and storage device, technologies for processing small volume samples in a centralized setting, and a compact fully-integrated and automated field-deployable diagnostic testing platform. Ms. Holmes will present reproducibility and correlation data for various tests comparing Theranos' capillary collection and storage device with traditional venipuncture methods. She will also discuss methodology employed for their diagnostic testing platform, and share data to demonstrate the precision and accuracy of these chemistry, immunochemistry, hematology, and molecular assays (traditionally performed on separate instruments) using their analytical testing platform, including a novel molecular test for the Zika virus.Following the presentation by Ms. Holmes, there will be a moderator-led Q&amp;A session featuring questions submitted in real-time by members of the audience. The moderator panel will include Drs. Patti Jones, PhD; Y.M. Dennis Lo, DM, DPhil, FRCP, FRCPath; and Stephen Master, MD, PhD. This interactive session is not part of the accredited educational program, and as such will not receive Continuing Medical Education or ACCENT credit. <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/veinviewer-medical-device-2016-3">This medical device should make drawing blood a lot less painful </a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="swMDVpMTE6SJ5n-XvdKmO31ngJXeEGVM" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

 Theranos is finally going to share data on its controversial blood tests on Monday - but don't get your hopes up 

<ul><li>In an ongoing fight against the novel <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword>, the researchers have developed a new test that can diagnose <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword> in just 20 minutes.</li><li>According to the researchers, the test is highly accurate and easy to use, making it a prime candidate for use in settings with limited testing capabilities.</li><li>The method involves using a small portable machine, which can reliably detect SARS-CoV-2 from just one nasal swab.</li></ul> In an ongoing fight against the novel coronavirus, the researchers have developed a new test that can diagnose Covid-19 in just 20 minutes. The findings, published in the Journal of Medical Microbiology, show the rapid molecular test called N1-STOP-LAMP, is 100 per cent accurate in diagnosing samples containing SARS-CoV-2 at high loads. "STOP-LAMP is what's referred to as a 'near care' test, it is not intended to replace the current gold standard PCR testing," said study lead author Tim Stinear, Professor at the University of Melbourne in Australia. "It's a robust diagnostic test for the specific and rapid detection of Covid-19. But it's important to note however, it trades some detection sensitivity for speed and ease-of-use," he added. According to the researchers, the test is highly accurate and easy to use, making it a prime candidate for use in settings with limited testing capabilities. The method involves using a small portable machine, which can reliably detect SARS-CoV-2 from just one nasal swab. In the race to control the Covid-19 pandemic, access to rapid, precision diagnostics is key, the research team said. "We have developed an alternative Covid-19 molecular test that can be readily deployed in settings where access to standard laboratory testing is limited or where ultra-rapid result turnaround times are needed," said Stiner. The study revealed that this new test uses only one tube and involves only a single step, making it more efficient and lower cost than many of the current tests for SARS-CoV-2. The N1-STOP-LAMP method was found to be 100 per cent accurate and correctly identified 87 per cent of tests as positive when used to assess 157 confirmed-positive samples. The results were fast, with an average time-to-positive of 14 minutes for 93 of those clinical samples. "We see this kind of technology having a benefit in settings liked aged care facilities or overseas laboratories with limited resources and equipment," Professor Stinear said. "The test requires a small shoebox-sized machine, as well as reagents, but everything is portable," he noted. SEE ALSO: <a href="https://www.businessinsider.in/india/news/heres-how-indias-74th-independence-day-celebrations-will-take-place-this-year/slidelist/77523536.cms">Here’s how India’s 74th Independence Day celebrations will take place this year</a> <a href="https://www.businessinsider.in/careers/news/how-much-deloitte-kpmg-ey-and-pwc-accountants-and-consultants-make-from-entry-level-to-executive-roles/articleshow/77533447.cms">How much Deloitte, KPMG, EY, and PwC accountants and consultants make, from entry level to executive roles</a> <a href="https://www.businessinsider.in/science/news/a-dwarf-planet-between-mars-and-jupiter-has-a-salty-ocean-beneath-its-surface-making-it-a-contender-for-alien-life/articleshow/77495476.cms">A dwarf planet between Mars and Jupiter has a salty ocean beneath its surface, making it a contender for alien life</a>

This new test to diagnose Covid-19 in just 20 minutes

Boston, Jul 2 () A review of studies has found major weaknesses in the evidence base for diagnostic accuracy of COVID-19 antibody tests, particularly for point-of-care tests performed directly with a patient, outside a laboratory, and does not support their continued use. Serological tests to detect antibodies against COVID-19 could improve diagnosis and may be useful tools for monitoring levels of infection in a population, but it is important to formally evaluate whether there is sufficient evidence that they are accurate, the researchers said. The study, published ín The BMJ, set out to determine the diagnostic accuracy of antibody tests for COVID-19. The researchers, including those from Harvard Medical School in the US and University of British Columbia, Canada, searched medical databases and preprint servers from January 1 to April 30, for studies measuring sensitivity and specificity of a COVID-19 antibody test compared with a control test. Sensitivity measures the percentage of people who are correctly identified as having a disease, while specificity measures the percentage of people who are correctly identified as not having a disease, they said. Of 40 eligible studies, most (70 per cent) were from China and the rest were from the UK, US, Denmark, Spain, Sweden, Japan and Germany. The researchers noted that half of the studies were not peer reviewed and most were found to have a high or unclear risk of bias -- problems in study design that can influence results. Only four studies included outpatients and only two evaluated tests at the point of care, they said. When sensitivity results for each study were pooled together, they ranged from 66 per cent to 97.8 per cent depending on the type of test method used, meaning that between 2.2 per cent and 34 per cent of patients with COVID-19 would be missed, according to the researchers. Pooled specificities ranged from 96.6 to 99.7 per cent, depending on the test method used, meaning that between 3.4 per cent and 0.3 per cent of patients would be wrongly identified as having COVID-19, they said. The study found that pooled sensitivities were consistently lower for the lateral flow immunoassay (LFIA) test compared with other test methods. The LFIA test is the potential point-of-care method that is being considered for 'immunity passports.' The researchers explained that, if an LFIA test is applied to a population with a COVID-19 prevalence of 10 per cent, for every 1,000 people tested, 31 who never had COVID-19 will be incorrectly told they are immune, and 34 people who had the disease will be incorrectly told that they were never infected. Pooled sensitivities were also lower with commercial test kits (65 per cent) compared with non-commercial kits (88.2 per cent) and in the first and second week after symptom onset compared with after the second week, they said. The researchers point to some limitations, such as differences in study populations and the potential for missing studies. However, study strengths include thorough search strategies and assessment of bias, they said. "These observations indicate important weaknesses in the evidence on COVID-19 serological tests, particularly those being marketed as point-of-care tests," the researchers said. "While the scientific community should be lauded for the pace at which novel serological tests have been developed, this review underscores the need for high quality clinical studies to evaluate these tools," they added. SAR SAR

Weak evidence for accuracy of COVID-19 antibody tests: Study

With advancements in medical technology, novel diagnostic tools are emerging to facilitate early and accurate detection of <keyword id="24487" type="General" weightage="20" keywordseo="Alzheimers" source="Orion">Alzheimer's</keyword> disease, according to a report on Friday. Alzheimer's disease, a progressive neurodegenerative disorder, poses significant challenges to individuals, caregivers, and healthcare systems worldwide. Early detection plays a crucial role in managing the disease and improving patient outcomes. Researchers and medical device manufacturers have been working tirelessly to develop innovative solutions for early Alzheimer's detection, revealed the report by <keyword id="1670029" type="General" weightage="100" keywordseo="globaldata" source="Orion">GlobalData</keyword>, a leading data and analytics company. Prominent among these advancements is the development of blood-based biomarker tests, such as the recently introduced AD-detect blood test, amyloid beta biomarkers, tau protein biomarkers, and neurofilament light (NfL) Biomarkers. These groundbreaking tests detect specific biomarkers associated with Alzheimer's disease, providing a non-invasive and accessible method for early detection and monitoring of the disease progression. Leading pharmaceutical companies and research institutions are actively involved in clinical trials and studies to evaluate the effectiveness of these biomarker tests. The results so far have been promising, showing great potential for improving early diagnosis and intervention strategies for the neurodegenerative disease, the report said. "Early detection of Alzheimer's disease allows for timely interventions, including lifestyle modifications and potential treatment options, which can significantly impact the quality of life for individuals affected by the disease. The development of blood-based biomarker tests is a significant breakthrough in the field, offering a more accessible and convenient approach to detecting Alzheimer's at its early stages," said <keyword id="17233470" type="General" weightage="80" keywordseo="cynthia-stinchcombe" source="Orion">Cynthia Stinchcombe</keyword>, <keyword id="17367395" type="General" weightage="80" keywordseo="medical-analyst" source="Orion">Medical Analyst</keyword> at GlobalData, in a statement. "The advancements in diagnostic tools for early detection of Alzheimer's disease bring hope to millions of people worldwide. By increasing awareness, supporting ongoing research, and ensuring widespread access to these innovative diagnostic tests, we can make significant strides in improving the lives of those affected by Alzheimer's and moving closer to effective treatments," Stinchcombe added. The month of June is designated as Alzheimer's and <keyword id="17723100" type="General" weightage="50" keywordseo="brain-awareness-month" source="Orion">Brain Awareness Month</keyword>. It is dedicated to raising awareness about Alzheimer's disease, brain health, and supporting individuals and families affected by this condition. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/ramkrishna-forgings-titagarh-rail-consortium-bags-12227-crore-order-from-railways/articleshow/101039655.cms">Ramkrishna Forgings-Titagarh Rail consortium bags ₹12,227 crore order from railways</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/retail/e-commerce/news/magicpin-clocks-50-monthly-growth-on-ondc-with-over-30000-daily-orders/articleshow/101039648.cms">Magicpin clocks 50% monthly growth on ONDC with over 30,000 daily orders</a>

More diagnostic tools for early detection of Alzheimer's underway: GlobalData

<div class="KonaFilter image-container display-table"><div><div class="image on-image">Shutterstock</div></div></div><ul class="summary-list"><li>A Silicon Valley blood-testing startup called Telomere Diagnostics sells a $99 kit that tells customers the average length of their telomeres.</li><li>Telomeres are seen by some researchers as a holy grail of aging. Unlike other factors, such as your genetics or upbringing, telomere length appears to change in response to behaviors like diet and exercise. </li><li>But two of Telomere Diagnostics' original founders, along with a NASA researcher who specializes in telomeres, raised doubts about the efficacy of the test.</li><li>A former Telomere Diagnostics employee also alleged that the company's lab was "filthy" and said she didn't "believe in the <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">science</keyword>" behind the test.</li></ul>Age is just a number, unless you're talking about your "cellular age."Cellular age, according to a Silicon Valley company called Telomere Diagnostics, reveals more about your health than a birth date ever could.Telomere Diagnostics sells a $99 at-home blood-testing kit that tells customers the average length of their telomeres, the tiny protective caps on our DNA believed to protect us from aging's steady wear and tear.Then the company offers health advice based on the test results.Telomeres are seen by some researchers as a holy grail of aging. That's because unlike other factors such as your genes or upbringing, telomere length appears to change in response to a variety of activities. Commit to regular exercise and your telomeres will grow, Telomere Diagnostics claims. Start binging on fast food and they'll shrink."It's like a fitness tracker for your DNA," Jason Shelton, the CEO of Telomere Diagnostics, told Business Insider. "It can change based on actions you take, and you can see the results immediately."But two of Telomere Diagnostics' three original founders, along with a NASA researcher who specializes in telomeres, aren't so sure.Elizabeth Blackburn, a biologist at the University of California at San Francisco, who won the Nobel Prize for her work on telomeres, in 2009, cofounded Telomere Diagnostics in 2010. The company still shows images of a Nobel Prize on its website, but Blackburn left the company more than five years ago because of concerns she had about its products.Elissa Epel, another UCSF researcher who cofounded the company with Blackburn, left at the same time for the same reasons.Both researchers told Business Insider that they questioned the efficacy of Telomere Diagnostics' test. And a former Telomere Diagnostics employee said she witnessed practices that raised doubts about the company's cleanliness, commitment to scientific accuracy, and handling of private health information.<h2>The emerging science of telomeres</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image">NIHTelomeres, in white, are structures at the tips of chromosomes, in blue.</div></div></div>In 2009, Blackburn <a href="http://biochemistry2.ucsf.edu/labs/blackburn/index.php?Itemid=3"> shared the Nobel Prize in medicine</a> for her work demonstrating that our cells' chromosomes - the wishbone-shaped structures that contain our DNA - are capped with delicate structures, or telomeres, that help shield our genetic material from wear and tear.It gave rise to a fervor of telomere research. Nearly 1,300 papers containing the word "telomeres" came out in 2017 - a nearly fourteenfold increase from 1991, when there were fewer than 100 such papers.But the links between telomere length, health, and aging are not yet clear cut.Shorter telomeres have been tied to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5042389/">higher rates of disease</a>,<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5379954/"> faster tumor growth</a>, and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2790562/"> overall age-related degeneration</a>. But longer telomeres have not been tied to the opposite outcomes; several recent studies have failed to find <a href="https://www.ncbi.nlm.nih.gov/pubmed/28887594">any link between long telomeres</a> and positive health effects, and longer-than-normal telomeres have also been tied to an <a href="https://www.ncbi.nlm.nih.gov/pubmed/27498151">increased risk of cancer</a>.Many activities appear to have the power to grow or blunt telomeres, from exercise to smoking, but scientists have not yet been able to prove that this relationship is causal. That means that we still do not fully understand telomeres or their role in aging and disease. So trying to lengthen or shorten your telomeres as a health intervention is arguably premature and, at worst, harmful, some experts say.And there is no recognized optimal telomere length for health. According to Blackburn, that makes the idea of telling someone their cellular age based on the length of their telomeres problematic - at least for now.Still another hurdle is that measurements of telomere length vary depending on the method used to test them. Some testing procedures look at the length of all the telomeres in a given blood sample and give you the average - the method that Telomere Diagnostics uses - while other tests focus exclusively on the shortest telomeres in a sample.But telomere science is a highly promising area for future studies, many researchers say. When looking across large populations, telomeres hold intriguing clues about how everything from diet to smoking affects our cells and their ability to self-repair and replenish."The research uses of telomere analyses, done with high quality controls and on sufficiently large and carefully done cohort studies, are scientifically valuable," Blackburn said. "It is just the value right now of commercial testing of individuals without clearly telling those tested the whole story that I find questionable."<h2>A NASA scientist says astronaut Scott Kelly 'threw a wrench' into one hypothesis about telomeres</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image"><a href="https://www.nasa.gov/content/scott-kelly-and-mark-kelly-at-the-johnson-space-center">NASA</a>Twin astronauts Scott Kelly, right, and Mark Kelly are helping NASA explore what life in space does to the human body.</div></div></div>Because of their potential connection to aging, stress, and disease, telomeres are of particular interest to researchers at NASA.As part of its <a href="https://www.businessinsider.com/nasa-twin-study-new-results-mark-scott-kelly-2017-10"> NASA Twin Study</a>, researchers are using Scott Kelly and his identical twin brother, Mark, to explore how the intense stress of spaceflight spurs changes inside the body. Scott lived in space for a year while his Mark stayed on Earth, and scientists examined Scott's genes after he returned.They found evidence of a body trying to protect itself from strain. But his telomeres did not respond the way scientists had expected. Instead of shrinking, as telomeres are believed to do in response to stress or negativity, they grew longer.<a href="https://www.nasa.gov/twins-study/meet-the-researchers/telomeres">Susan Bailey</a>, a professor of radiation-cancer biology and one of the lead NASA researchers studying the Kelly twins, told Business Insider that the discovery "threw a wrench into the hypothesis" that healthy behaviors lengthen telomeres while unhealthy ones shorten them.It was a reminder, she said, of how much we still don't know about the links between telomeres, health, and aging."There's a lot of good research that shows shorter telomeres are linked with heart disease, whereas longer ones are associated with an increased risk of things like cancer," Bailey added. "I think you have to balance those things. It's not just, 'Oh, I have longer telomeres, so I'm going to live longer and be healthier.' You may live longer, but you may get cancer, too."<h2>From Nobel Prize to brazen startup</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image">Getty Images / Justin SullivanElizabeth Blackburn, right, celebrates her Nobel Prize in medicine.</div></div></div>After she discovered telomeres, Blackburn believed that measuring them could give doctors and patients a way to spot signs of poor health early. So in 2010 she founded Telome Health along with Epel and another UCSF researcher, Jue Lin, who still serves on the company's scientific advisory board but told Business Insider she was "not very" involved with them. The startup aimed to help accelerate the pace of telomere research."Our vision was to enroll people in research [with a consent form], tell them their results in a responsible way, and learn more about the effects of testing," Epel said.Blackburn served as a cofounder, board member, and chair of the company's scientific advisory committee.Several of Blackburn's colleagues in the field expressed doubts about the usefulness of the blood test between 2010 and 2013, but she called the test's utility "a no-brainer" in 2013 interview with <a href="https://www.nytimes.com/2013/04/09/science/elizabeth-blackburn-molecular-biologist-charts-her-own-course.html">The New York Times</a>.A few months after that interview, Blackburn left Telome Health. The decision, she told Business Insider, was the result of an internal conflict. A board member wanted to team up with a supplement company called TA Sciences, which was making a plant-extract pill that it claimed could lengthen telomeres and fight aging and disease.Blackburn said she had concerns that the supplement, known as TA-65, "carried a very scientifically plausible risk of being cancer-causing." The board out-voted Blackburn."This was sufficient for me ... to sever [my] relationship with the company," she said.TA-65 is made with telomerase, an enzyme that appears to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3045570/">spur telomeres to elongate</a>. But that growth may also <a href="https://www.ejcancer.com/article/S0959-8049(97)00062-2/abstract">seed the germination of cancer cells</a> by making it easier for them to proliferate, according to research from several biologists, including Blackburn.Jim Cich, the president of TA Sciences, told Business Insider that he believed Blackburn's doubts "revolved around a worry a few people had in the early days of telomere biology," adding that those concerns were "currently out of date with the thinking of most telomere biologists."But a study <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4915101/">published in the journal Genome Medicine</a> in 2016 suggested that deactivating telomerase - as opposed to reactivating it, as TA-65 claims to do - could be a promising anticancer treatment.Cich, however, said TA-65 was safe and effective."TA Sciences has spent several million dollars on product testing including double-blind, placebo-controlled clinical trials that demonstrate the effectiveness and safety of TA-65," he said.Within a year of leaving the company, Blackburn had stepped down from all leadership roles and donated all of her equity to a nonprofit. Epel and Lin Blackburn's cofounders, also left at that time for the same reason."The company's direction was drifting away from the scientific basis underpinning its formation," Blackburn thought.But the work continued. The company changed its name to Telomere Diagnostics and began selling its telomere testing kits, called TeloYears, for $99. Lin, the third cofounder, rejoined the company's scientific advisory board at this time.When asked about the test's accuracy, Jason Shelton, Telomere Diagnostics' CEO, said that since he took on a leadership role at the company, in 2014, "We have remained strongly committed to advancing telomere science." To that end, the company published an <a href="http://jalm.aaccjnls.org/content/early/2017/04/20/jalm.2016.022137">article in a peer-reviewed journal</a> last year that said the company's telomere-measuring techniques were scientifically valid.Shelton said the company's relationship with TA Sciences "was terminated" when he took over in 2014.Today, Telomere Diagnostics sells a different supplement that it says is based on scientific research that has found links between various vitamins - including vitamins D and E - and longer telomeres.Telomere Diagnostics is now doing well financially, according to Alexandre Levert, a board member who represents a French shareholder in the company. Levert told Business Insider that 2017 was one of the "strongest years so far" in terms of revenue.<h2>How Telomere Diagnostics determines cellular age</h2>The process of getting your cellular age from the TeloYears test is somewhat similar to the one that genetics and ancestry-testing companies use. Customers get a box in the mail, which contains a kit for providing biological samples (TeloYears uses blood; other companies use saliva). Customers follow the instructions, then ship their blood sample back to the company for processing.Once a doctor signs off on the order, customers receive a report in the mail that purports to tell them whether the age of their cells "in TeloYears" is older or younger than their actual age. This result is an indicator of "how well a person is aging," Shelton said."You can use your results to improve your overall health by finding … the motivation to take steps to slow down the clock on the aging process," the Telomere Diagnostics website reads.Those steps, according to the company, involve more exercise, sleep, and healthier eating."Your TeloYears results can also be used, through repeat testing, to track how your choices are affecting your aging," the description says.All those recommendations are "common sense," Lin, the third cofounder, told Business Insider. Despite this, she said the test would be helpful to many people who "don't have the motivation to improve or maintain their health.""If knowing your telomere length is the thing that allows them to have that motivation, that could be a potential use," Lin said.<h2>'I didn't believe in the science'</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image">Shutterstock</div></div></div>A former Telomere Diagnostics employee, who worked for the company as a supervisor on a contract basis in 2017, spoke with Business Insider anonymously about her experience out of fear of retribution.Several events made her uneasy about the work she was doing, she said. On one occasion, the employee said, a Telomere Diagnostics customer complained that their TeloYears results were inaccurate. The customer said that because they regularly exercised and ate healthy, they must have a younger "cellular age" than the one the test yielded. According to the employee, Telomere Diagnostics responded by sending the customer a new kit, then returned results showing a new "cellular age" that was decades younger."The test is garbage," she said, adding, "I didn't believe in the science."Shelton denied that the company had ever fudged the numbers on a report and said such behavior would be grounds for firing an employee.The former employee also alleged that she observed several organizational errors in the lab that jeopardized patient privacy. She twice saw staff members accidentally mix up customers' test results, she said, which led them to mail one customer's health information to the wrong person. In one of those cases, a customer sent back a report that belonged to another patient, she alleged.Shelton said those two errors did occur, but said "both were promptly rectified."Finally, the employee alleged that Telomere Diagnostics' lab was once infested by mice. She said she raised the issue "over and over again" in meetings with management, but "people wouldn't listen." She quit."That lab is the filthiest, most screwed-up lab I've ever seen in my life," she said, adding, "I'm honestly stunned that they're still in existence."The former employee also worked in the lab of Silicon Valley blood-testing startup Theranos, which was plagued by scandal and <a href="https://www.businessinsider.com/theranos-lessons-tips-silicon-valley-biotech-investors-2018-8">announced plans to formally dissolve</a> in September.Shelton did not deny the allegation about a mouse infestation but said "any traces of pests would be addressed according to accepted pest-control procedures."Levert, the Telomere Diagnostics board member, agreed with Shelton, telling Business Insider that during his "regular" visits to the company's lab he never saw any evidence supporting the former employee's claims."We're putting all of our efforts into a really high-quality lab where we're upgrading regularly," Levert said. "Any inspections we've had have been very positive."<h2>2 founders raise questions over accuracy</h2>Some researchers who specialize in telomeres - including Blackburn and Epel - said the science wasn't yet advanced enough for any company to offer health advice based on measurements of telomere length."Telomere length is another risk factor, just like cholesterol," Epel told Business Insider. "But the current tests for it are probably not accurate for widespread use, or for single use for individuals."Bailey, the NASA scientist, said a few crucial steps were necessary before such tests could be considered trustworthy."At the most basic level, one of the first things we need to do is standardize how telomere length is being measured and make sure we're measuring what we think we're measuring in the first place," Bailey said.But Shelton, Telomere Diagnostics' CEO, said telomeres' malleability is precisely what makes them useful."If you do an ancestry test, there's no amount of push-ups you can do that can change what percent Irish you are," Shelton said. "But your telomere length is one of those unique parts of DNA that's been shown in clinical studies to change based on a variety of lifestyle modifications."Shelton encouraged customers to take the test several times so that they could track how their telomere length shifts based on, say, eating healthier or working out more regularly."We can help inspire people to improve their overall lifestyle and engage on their own personal journey through what is perhaps the oldest and most important problem shared by all mankind," he said. "How do you put more years in your life, and how do you put more life in your years?"But of course the more times a person takes the TeloYears test, the more money Shelton's company makes. <div class="margin-top"> <h3>NOW WATCH: <a href="https://www.businessinsider.com/is-it-bad-to-eat-moldy-bread-2018-8">Never eat the 'clean' part of moldy bread</a></h3> <div> </div> </div>

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