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London, Scientists have discovered that there is a type of <keyword id="57072" type="PERSON" weightage="20" keywordseo="Brain-Cell">brain cell</keyword> that can track how far we have travelled and remember where things are, which are added to our <keyword id="8815269" type="UNKNOWN" weightage="20" keywordseo="memory-map">memory map</keyword> of the places we have been.<br /><br />The existence of GPS-like brain cells, which can store maps of the places we've been, like our kitchen or holiday destination, was already widely known, but this discovery shows there is also a type of brain cell sensitive to the distance and direction of objects that can store their locations on these maps.<br /><br />The findings, detailing these cells called <keyword id="10477094" type="UNKNOWN" weightage="20" keywordseo="vector-trace-cells">vector trace cells</keyword> (VTC), were published in the journal <keyword id="1647146" type="PERSON" weightage="20" keywordseo="Nature-Neuroscience">Nature Neuroscience</keyword>.<br /><br />"The discovery of vector trace cells is particularly important as the area of the brain they are found in is one of the first to be attacked by brain disorders such as Alzheimer's disease, which could explain why a common symptom and key early 'warning sign' is the losing or misplacement of objects," said lead researcher Steven Poulter from Durham University in Britain.<br /><br />According to <keyword id="10477093" type="PERSON" weightage="20" keywordseo="colin-lever">Colin Lever</keyword> from Durham University, these cells appear to connect to creative brain networks which help us to plan our actions and imagine complex scenarios in our mind's eye. <br /><br />"Vector trace cells acting together likely allow us to recreate the spatial relationships between ourselves and objects, and between the objects in a scene, even when those objects are not directly visible to us," Lever said.<br /><br /><strong>SEE ALSO:<br /><a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-spicejet-interglobe-aviation-tata-motors-pfizer-asian-paints-niit-lupin-and-others/articleshow/79849749.cms">Top stocks to watch – SpiceJet, InterGlobe Aviation, Tata Motors, Pfizer, Asian Paints, NIIT, Lupin, and others</a><br /><a href="https://www.businessinsider.in/stock-market/news/how-to-check-mrs-bectors-food-specialities-ipo-allotment-status-online/articleshow/79808672.cms?upcache=2">Mrs Bectors Food Specialities IPO allotment today: Here’s how to check share allotment status</a><br /><a href="https://www.businessinsider.in/business/startups/news/google-microsoft-invest-in-dailyhunt-for-its-short-video-platform-josh-making-it-the-latest-unicorn-in-india/articleshow/79850804.cms">Google, Microsoft invest in DailyHunt for its short video platform Josh – making it the latest unicorn in India</a></strong><br />

Scientists discover GPS-like brain cells that can boost our memory map and help track distance discovered

<ul class="summary-list"><li><keyword id="4912868" type="PERSON" weightage="60" keywordseo="moderna">Moderna</keyword>'s <keyword id="2667287" type="PERSON" weightage="60" keywordseo="mRNA">mRNA</keyword> tech could change the game in the decades-long effort to develop an HIV vaccine.</li><li>The company said it expects to begin two vaccine trials in humans by the end of 2021.</li><li>While "excited" by the prospect, HIV researchers caution there's a long road ahead for mRNA vaccines.</li></ul><p>Moderna's investor presentation on Wednesday showcased the Massachusetts-based <keyword id="45082" type="PERSON" weightage="60" keywordseo="biotech">biotech</keyword>'s efforts to develop vaccines against HIV and <a href="https://investors.modernatx.com/static-files/2a60b8d1-1210-4596-b51c-a57b3cba1c8f">eight</a> other <a href="https://www.businessinsider.com/modernas-5-biggest-vaccine-programs-after-covid-19-2021-4">infectious diseases.</a></p><p>The company's mRNA technology, which has built upon <a href="https://www.businessinsider.com/mrna-vaccine-pfizer-moderna-coronavirus-2020-12">decades of research</a>, will now contribute to the long frustrated effort to contain the global HIV/AIDS epidemic.</p><p>Working in collaboration with the National Institutes of Health, Scripps Research, the Gates Foundation, and other partners, Moderna said it would begin testing two HIV vaccine candidates in humans by the end of 2021.</p><p>The COVID-19 vaccine developer's long-term goal is to show that its mRNA-based vaccine can produce <a href="https://www.avac.org/blog/rise-broadly-neutralizing-antibodies">broadly neutralizing antibodies</a>, a type of immune response that researchers believe will be protective against circulating HIV strains around the world.</p><p>"Think about the people who die of HIV every year, the people who aren't alive because they don't have the amazing therapy available in this country," CEO Stephane Bancel told Insider <a href="https://www.businessinsider.com/moderna-developing-covid-19-flu-rsv-combo-vaccine-2021-4">in an interview Tuesday</a>. In <a href="https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics">2019</a>, 700,000 people died of AIDS-related causes, the disease caused by HIV, and an estimated 1.7 million individuals contracted HIV.</p><p>However, two veteran HIV/AIDS researchers told Insider that while they're excited by the prospect of using mRNA technology to develop an HIV vaccine, there's a long road ahead for all players involved. Moderna's mRNA technology will indisputably speed up the "fine-tuning" of HIV vaccine development, but only continued testing will show if the end result is actually safe and effective. </p><p>Emory University virology professor Rafick-Pierre Sekaly, who has studied HIV for two decades, said it would be "crazy not to test" whether mRNA technology could bypass the expensive, slow process of generating these protein fragments in the lab.</p><p>"We had such a spectacular outcome with <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> that we absolutely need to embark on this platform and test it," Sekaly said. "None of the other [HIV] platforms have generated any inkling of promising results." </p><p><em><strong>Read more: </strong><a href="https://www.businessinsider.com/modernas-5-biggest-vaccine-programs-after-covid-19-2021-4">Moderna is betting its mRNA technology will lead to a new wave of vaccines for diseases like HIV. Here are the top 5 it's working on beyond COVID-19.</a></em></p><h2><strong>Moderna's partnership will build on a new and unproven vaccine approach </strong></h2><p>William Schief, an immunology professor at Scripps Research and vaccine design director of the International AIDS Vaccine Initiative, presented Moderna's investors with unpublished data from an HIV vaccine trial presented at a <a href="https://www.scripps.edu/news-and-events/press-room/2021/20210203-hiv-vaccine.html">virtual AIDS research conference</a> in February.</p><p>The trial, which started in 2018, was conducted with 48 HIV-negative adults, and will serve as preliminary basis off which Moderna and its collaborators will further study and test a vaccine approach targeting broadly neutralizing antibodies. Subjects were given either a low or high dose of the <a href="https://www.iavi.org/news-resources/press-releases/2018/iavi-announces-clinical-trial-of-next-generation-hiv-vaccine-candidate-designed-to-induce-antibodies-to-block-hiv-infection">protein-based vaccine candidate</a>, which was designed to activate certain "naive" B cells of the immune system. </p><p>When activated, the B cells produce proteins that eventually give rise to the hoped-for broadly neutralizing antibodies.</p><p>"The importance of priming these naive B cells is the key first step," Schief said on the investor call. "If you can't get that to work, the whole thing isn't going to work."</p><p>After being treated with the experimental vaccine, 47 out of 48 participants showed the targeted levels of naive B cells critical in eventually producing the antibodies, though the data remains subject to peer review. The final study volunteer dropped out. </p><p>Moderna's cost and time-efficient mRNA technology will speed up the process of conducting clinical trials, Schief said. Relatively speaking, conventional in-lab protein manufacturing is slow and expensive. </p><p>"It took us years just to do that one trial, many years," he added, referring to 48-person study. "We need to do a lot of human clinical trials, and we think that Moderna mRNA is the technology that will let us do that."</p><p>Moderna plans to test two mRNA-delivered HIV vaccine candidates in humans, both of which will test for safety and efficacy. The first is based on the initial study's protein component, while the other will determine whether synthetic HIV-like antigens can provoke the desired immune response. Both trials will start by the end of <a href="https://www.businessinsider.com/modernas-5-biggest-vaccine-programs-after-covid-19-2021-4">this year</a>. </p><div type="image" title="Stephane Bancel" height="3179" width="4239" msid="82150635" hostid="261"></div><h2><strong>Compared to the virus behind COVID-19, HIV is a 'very different ballgame'</strong></h2><p>Dr. Ian Frank, an HIV vaccine researcher at the University of Pennsylvania who's helped develop HIV vaccines including one that made it to <a href="https://www.aidsmap.com/news/sep-2007/merck-hiv-vaccine-fails-trials-halted">late-stage trials in 2007,</a> said that the mRNA approach to developing an HIV vaccine has the advantage of speed and flexibility. Without scrutinizing the data from Schief's study, which is still undergoing peer review, it's a little difficult to understand the nuance, he said.</p><p>However, if the data show the vaccine created broadly neutralizing antibodies, this approach would signal a complete paradigm shift for HIV vaccine research, Frank said.</p><p>Despite the success of using mRNA to immunize against COVID-19, HIV is a "very different ballgame," Sekaly, the HIV researcher at Emory University, said. Once infected with HIV, the virus remains permanently active in a small number of cells in the body if left untreated, unlike the virus that causes COVID-19.</p><p>This means that a successful HIV vaccine has to overcome a higher hurdle than any other vaccine in history, Frank said. It would need to prevent infection, or the immune response underlying it, entirely. Other vaccines, including both Moderna and Pfizer-BioNTech's COVID-19 vaccines, only prevent the development of an infection into illness. </p><p>"For us to have an HIV vaccine that is effective in a way that will lead to prevention of infection, there's some fine tuning of this vaccine that is gonna need to happen," Frank said.</p><p>Although "excited" by the prospect of the Moderna partnership in HIV vaccine trials, Sekaly stressed that the mRNA-based delivery approach is still unproven beyond COVID-19, and emphasized the need for patient safety in clinical trials. </p><p>Both Frank and Sekaly said that the company's mRNA platform would likely enable any promising vaccine candidates to move from early to mid-stage clinical trials within a year - a much faster pace than vaccine development has historically gone.  </p><h2><strong>Moderna's mRNA candidates have breakthrough potential in the frustrating, costly search for an HIV vaccine</strong></h2><p>Speaking to Insider, company CEO Bancel acknowledged the inherent challenge in developing a safe and effective HIV vaccine, a global health problem whose solution has eluded researchers for four decades.</p><p>The last HIV vaccine candidate that had made it to late-stage studies in South Africa stopped in February 2020 after there was "<a href="https://www.sciencemag.org/news/2020/02/another-hiv-vaccine-strategy-fails-large-scale-study">absolutely no evidence of efficacy</a>," its head researcher told <keyword id="41551" type="ENTERTAINMENT" weightage="60" keywordseo="science">Science</keyword>. </p><p>An earlier version of the vaccine used in the South African study had only shown 31% efficacy in a previous <a href="https://www.nejm.org/doi/full/10.1056/nejmoa0908492">trial in Thailand</a>. Before that, the last HIV vaccine to make it to a late-stage clinical trial <a href="https://www.aidsmap.com/news/sep-2007/merck-hiv-vaccine-fails-trials-halted">concluded in 2007</a>. </p><p>The two remaining late stage clinical HIV vaccines trials, Mosaico and Imbokodo, are being run by Johnson &amp; Johnson and will not release results before the end of 2021.</p><p>Like the South African study halted in 2020, both trials use an inactive viral vector carrying genetic material <a href="https://www.nature.com/articles/d41586-019-02319-8">based on HIV's many strains</a> from around the world, as well as a synthetic protein mimicking part of a particle's envelope protein.</p><p>Even without Moderna involved, the HIV vaccine designed by Schief's team takes a different approach to tackling the virus than the one used in the J&amp;J trials. By using the same delivery method as both Moderna's and Pfizer-BioNTech's COVID-19 vaccines, researchers will be able to fine-tune versions of their vaccine even further, Frank said.</p><div type="image" title="AP21034450685389" height="2663" width="3550" msid="82150637" hostid="261"></div><h2><strong>COVID-19 vaccines have benefited from decades of HIV vaccine research</strong></h2><p>Although he finds the prospect of an mRNA vaccine exciting, Frank said Moderna and its partners have a long road ahead in proving if their mRNA-delivered protein approach is successful.</p><p>"The strategy has the potential to be a breakthrough, but it's the first step in a hard climb," Frank said. Moderna's mRNA technology will definitely give researchers the ability to test quickly, but that's all he can conclude. </p><p>"I'm sure they can get a candidate vaccine," Frank said. "The challenge will be how effective of an immune response it elicits." </p><p>The COVID-19 were been the breakthrough moment for mRNA vaccines, creating inroads for <a href="https://www.insider.com/vaccines-for-cancer-hiv-coming-thanks-to-covid-19-vaccine-2021-4">further HIV and cancer research</a>. However, according to a recent <a href="https://www.nber.org/system/files/working_papers/w28587/w28587.pdf">National Bureau of Economic Research</a> paper, it was actually decades of collective failure and the billions of dollars poured into HIV vaccine research that laid the foundation for the COVID-19 vaccines.</p><p>Published in March, author Jeffrey E. Harris found that 86% of clinical COVID-19 vaccines could trace their scientific basis to past HIV vaccine trials. From this vantage point, Moderna's mRNA platform is actually just a brief interlude from directly HIV-oriented scientific research driving the latest efforts in curbing the HIV/AIDS epidemic.</p><p><em>Andrew Dunn contributed reporting. </em></p>

Moderna's mRNA technology could help in the decades-long search for an HIV vaccine

Why a coronavirus vaccine won't be ready for public distribution until 2021, according to a top virologist

<p><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><p class="source"><span>Gisela Greif/Bayer Animal Health GmbH</span></p><p class="caption">Babesia parasites inside a red blood cell, as seen with a scanning electron microscope.</p></div><p></p></div></div>Tiny parasites normally spread by ticks are increasingly sneaking into the US blood supply.</p><p>Called <em>Babesia</em>, the blood-loving parasites rarely kill. Many people don't even have symptoms after an infection.</p><p>It's not harmless, though. Babesiosis - the disease caused by <em>Babesia</em> - can be lethal to those with weak immune systems, among others who often need blood transfusions.</p><p>What's more, <strong>there's "no way of knowing" how many infected people are donating blood, </strong>according to a major blood donation center Tech Insider contacted. There's also no large-scale, US government-approved way to test for <em>Babesia</em> in the <a href="http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics">15.7 million blood donations</a> transfused into <a href="http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003387">5 million Americans</a> every year.</p><p>Those aren't the only <em>Babesia-</em>related issues troubling the Food and Drug Administration (FDA), which oversees the US blood industry. Tick-borne babesiosis infections are on the rise and, in lock-step, so are those linked to blood transfusions. <strong>Even though it's rare, babesiosis is the pathogen most often <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM449523.pdf">spread by blood transfusions</a>, according to reports in <a href="http://www.nejm.org/doi/pdf/10.1056/NEJMra1202018">The New England Journal of Medicine</a> and <a href="http://journals.lww.com/infectdis/Citation/2012/11000/Transplacental_Transmission_of_Human_Babesiosis.1.aspx">Infectious Disease in Clinical Practice</a>.</strong></p><p>Thankfully, the FDA and other organizations are trying to do something about the growing threat.</p><h2>A lurking danger</h2><p><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><p class="source"><span>Getty Images</span></p><p class="caption"> Nymph black-legged ticks (right) are tiny compared to adults (left) but are the most common vectors for Babesia microti, the parasite that causes babesiosis. </p></div><p></p></div></div>Almost all cases of babesiosis trace back to the bite of an infected deer tick, also called black-legged ticks. These are the same creepy crawlies responsible for the spread of Lyme disease - another tick-borne scourge experts have labeled an epidemic and a "<a href="http://www.techinsider.io/lyme-disease-ticks-may-cost-billions-with-no-vaccine-2015-7">public health fiasco</a>."</p><p><strong>Babesiosis isn't caused by bacteria or viruses.</strong> Rather, one-celled parasitic animals called sporozoans are responsible. And of the <a href="http://dx.doi.org/10.1128/CMR.13.3.451-469.2000">100-or-so known species</a>, <em>Babesia microti</em> are the sporozoans that most often infect humans.</p><p>Once inside a person's bloodstream, the microscopic creatures swim around until they find a red blood cell. They force their way inside, hijack the cell, and divide until it bursts. Then the sporozoans seek out new prey.</p><p><strong>Red blood cells bursting with parasites are, of course, not good for you.</strong> Babesiosis typically causes headaches, chills, sweats, and a high fever within weeks or months of infection. (Except in an unknown fraction of people who don't - but more on this shortly.)</p><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Alan R Walker/Wikimedia (CC BY-SA 3.0)</span></p><p class="caption">Babesia sporozoans in dog blood.</p></div><p></p></div></div></p><p>Like Lyme disease, babesiosis is pretty easy to treat if you're healthy. The prescription drugs <a href="http://dx.doi.org/10.1056/NEJM200103083441014">azithromycin and atovaquone</a>, which cost tens to a few hundred dollars per round, usually fight off a babesiosis infection in a <a href="http://dx.doi.org/10.1056/NEJMra1202018">matter of days</a>.</p><p><strong>However, even with treatment, as much as <a href="http://www.columbia-lyme.org/patients/tbd_babesia.html">20% of infections are fatal</a> in a cluster of high-risk groups</strong>: infants, the elderly, people without a spleen, and those with weakened immune systems, including cancer patients on immunosuppressive drugs.</p><p>Unlike Lyme disease, which triggers a big rash in <a href="http://www.sciencedirect.com/science/article/pii/S0891552015000240">60-75% of infections</a>, babesiosis has no dead-giveaway signs. Weeks or months after infection by <em>Babesia</em>, you might think you have a stubborn flu or, with milder cases, a cold - perhaps not anything serious.</p><p><strong>But 25% of infected adults and 50% of infected kids show <a href="http://www.nejm.org/doi/full/10.1056/NEJMra1202018">no symptoms at all</a>. </strong>Without treatment, such infections can last months or even years.</p><p>And therein lies the problem.</p><p>"There are tons of people out in [Long Island, New York] who've been infected but don't get sick," Debra Kessler, director of special donor services at the New York Blood Center, told Tech Insider. "They come in and donate blood because they feel fine."</p><p>Right now, the only thing specific to babesiosis that's preventing asymptomatic people from donating infected blood is a check box on a <a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/UCM213552.pdf">standard screening questionnaire</a>.</p><p>Those unknowingly infected by <em>Babesia</em> are ticking the wrong box:</p><p><div class="KonaFilter image-container display-table"><div><div class="image"><p class="source"><span><a href="http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm332017.htm">FDA</a></span></p></div><p></p></div></div></p><h2>Tip of the 'bloodberg'</h2><p>The Centers for Disease Control (CDC) logged <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM446274.pdf">3,862 reported cases</a> of babesiosis in the US from 2011-2013. About three-fourths of reported infections were in the elderly.</p><p>National data before 2011 is scant. That's because the CDC wasn't demanding it - it didn't deem babesiosis a "<a href="http://wwwn.cdc.gov/nndss/">national notifiable condition</a>," which all state health agencies should report annually, until 2011.</p><p><div class="KonaFilter image-container display-table"><div><div class="image"><p class="source"><span><a href="http://www.cdc.gov/parasites/babesiosis/data-statistics/index.html">CDC</a></span></p></div><p></p></div></div></p><p>With the data the CDC has now, they can see babesiosis cases always spike during the summer.</p><p>That's because ticks flourish in forests and fields during warm periods, feasting upon hapless humans and other mammals.</p><p><div class="KonaFilter image-container display-table"><div><div class="image"><p class="source"><span><a href="http://www.cdc.gov/parasites/babesiosis/data-statistics/index.html">CDC</a></span></p><p class="caption">Known US cases of babesiosis in 2013 by month.</p></div><p></p></div></div></p><p>Five high-risk states - <strong>Rhode Island, Massachusetts, Connecticut, New York, and New Jersey</strong> - are the biggest hotbeds for babesiosis. Together they account for more than 85% of cases.</p><p>Yet infections appear across the the Northeast and the Midwest, too, since both regions are crawling with black-legged ticks:</p><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span><a href="http://www.cdc.gov/parasites/babesiosis/data-statistics/index.html">CDC</a></span></p><p class="caption">Babesiosis cases by county in 2013.</p></div><p></p></div></div></p><p>A few thousand cases in a few years, concentrated in a few states, might not seem like a lot. And against a backdrop of more than 300 million Americans, it isn't.</p><p><strong>But the true scope of <em>Babesia</em>'s grasp on the country is unknown, and the government as well as blood centers are quick to admit it.</strong></p><p>First, the CDC relies on states to compile and report cases to the government. But states aren't required to participate - and not all of them do. (Lyme disease has a similar problem with vast underreporting; <a href="http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html">10 times the reported cases</a> likely exist.)</p><p>"So far 31 states have participated, and the disease has been reported from 36 states," Sanjai Kumar, who studies pathogens for the FDA, said during the agency's most recent <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM449523.pdf">blood safety committee meeting</a> on May 13, 2015.</p><p>Second, most people don't know they have babesiosis, if they have symptoms at all. So it's unknown how many people are undiagnosed.</p><p><strong>Hence, babesiosis is the parasitic disease <a href="http://www.cdc.gov/parasites/babesiosis/resources/babesiosis_policy_brief.pdf">most often</a> <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM449523.pdf">spread by transfusions</a>.</strong></p><p>Back in 1994, it was found that about <a href="http://jid.oxfordjournals.org/content/170/1/231">one in 601 tested blood transfusions</a> in Connecticut - one of the highest-risk states - resulted in a babesiosis infection. But with "expanding areas of transmission and infections" in recent years, an FDA representative told Tech Insider in a statement, <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM446274.pdf">this threat is increasing</a>.</p><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span><a href="http://www.cdc.gov/parasites/babesiosis/resources/babesiosis_policy_brief.pdf">CDC</a></span></p><p class="caption">Known cases of babesiosis caused by blood transfusion.</p></div><p></p></div></div></p><p>The raw numbers make the threat seem almost vanishingly small, with about 90 reported cases in a span of 5 years. But the actual scope of the problem is almost impossible to pin down.</p><p><strong>"I like to refer to the tip of the 'blood-berg,'"</strong> said Barbara Herwaldt, who studies parasitic diseases for the CDC, during the recent committee meeting. "Undoubtedly, the cases that have been recognized represent a fraction of those that have occurred, but the sizes of the relative fractions ... aren't known," Herwaldt said.</p><p>Also, blood donations - and generous donors - don't recognize state borders. People travel, and blood centers ship units to places in need.</p><p>"It's nationwide because the donors from non-endemic areas travel to endemic areas and acquire infection," Kumar said during the recent FDA blood products meeting. "Donors who normally reside in endemic areas may donate elsewhere."</p><p><div class="KonaFilter image-container display-table"><div><div class="image"><p class="source"><span><a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM446274.pdf">FDA</a></span></p><p class="caption">Babesiosis cases caused by blood transfusion in 2013 by state.</p></div><p></p></div></div></p><h2>'No way of knowing'</h2><p>Babesiosis was, for a long time, only a problem known to domesticated animals. Historical records tell us today that the first known human cases dates back to <a href="http://www.ncbi.nlm.nih.gov/pubmed/25780828">1910 in France</a>, but it wasn't until 1957 that researchers first described it in a Croatian farmer.</p><p><em>Babesia</em> soon made its way to Nantucket Island (and North America) in the late 1960s.</p><p>Since then, human populations have exploded in tick-infested regions, and so have the number of disease-carrying ticks. We've pushed disease-carrying ticks into new habitats through human-accelerated climate change. We've expanded prime tick habitat in the form of more suburban communities near forests and grassy fields. We've pushed out or eradicated predators that used to keep deer, mice, and other reservoirs for <em>Babesia</em> in check.</p><p><strong>In effect, we've increased our exposure to ticks and their ability to infect us.</strong></p><p>Beyond <a href="http://www.fda.gov/forconsumers/consumerupdates/ucm358486.htm">preventing</a> <a href="http://www.cdc.gov/features/lymedisease/">tick bites</a>, the easiest way to confront this growing threat to the blood supply is to screen blood donors for <em>Babesia</em> with a diagnostic test. Donated blood is <a href="http://www.redcrossblood.org/learn-about-blood/blood-testing">already tested</a> for HIV, Hepatitis B, syphilis, and other diseases.</p><p>The good news is that if someone infected with <em>Babesia</em> donates blood, there are some promising tests. An expert can also identify the parasite using an old-school method: examining suspect blood under a microscope.</p><p>The bad news is that looking at tens of millions of units of donated blood under a microscope every year isn't feasible (nor <a href="http://www.imugen.com/education/babesia.html">very sensitive</a>), and the <a href="http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm332017.htm">FDA has yet to approve a large-scale test the blood industry can use</a>.</p><p><strong>In effect, Kessler told Tech Insider in an email, "[w]e have no way of knowing how many people may be infected and donating."</strong></p><p>FDA <a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm">approval of a diagnostic test</a> isn't a bureaucratic formality. It mandates strong scientific evidence to show a test actually works, see how reliable it is, and single out its shortcomings - including the rate of misleading false-positive and false-negative results.</p><p>Two medical companies - <a href="http://igenex.com/Website/babesiosis.php">IGeneX</a> and <a href="http://www.imugen.com/education/babesia.html">Imugen</a> - are each developing two types of tests to detect babesiosis. One type looks for <em>Babesia</em> microbes directly by detecting their DNA in a person's blood. The other test looks for antibodies that a person's body generates to fight <em>Babesia</em>.</p><p>The FDA refused to discuss either company's products, since that would be <a href="http://www.gpo.gov/fdsys/granule/CFR-2011-title21-vol7/CFR-2011-title21-vol7-sec601-50">against</a> <a href="http://www.gpo.gov/fdsys/granule/CFR-2000-title21-vol7/CFR-2000-title21-vol7-sec601-51">the law.</a> Yet both manufacturers shared results with the FDA in May 2015 - and those results suggest the tests are <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM446274.pdf">upwards of 97% reliable</a> and thousands of times more sensitive than current methods, the blood-under-a-microscope method. Kessler said "licensure should come in the next year" for both types of tests, but didn't indicate the manufacturer.</p><p>Should the new tests work as well as manufacturers claim and get approved, <strong>the FDA has a plan to conservatively <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM446274.pdf%20">prevent 95%</a> of future blood-transfused cases of babesiosis</strong>. They'd do this by mandating antibody screening for blood donors in all 50 states, plus <em>Babesia </em>DNA testing in the five high-risk states.</p><p>But the FDA isn't stopping with diagnostic tests.</p><p>This month it unveiled two critical (if unassuming) tools to detect risks to the blood supply in real-time: <strong>an email survey system, plus a unified database to shared anonymized blood donor information with the government.</strong></p><p>Here's the debut email my wife received in August, since she's a frequent blood donor (if you can donate blood, you should - and regularly - since it saves lives):</p><p><div class="KonaFilter image-container display-table"><div><div class="image"><p class="source"><span><a href="http://nybloodcenter.org/">New York Blood Center</a></span></p></div><p></p></div></div></p><p>An email survey and shared database might sound obvious or even laughable as tools to fight infectious diseases.</p><p>But Mark Walderhaug, a microbiologist and babesiosis researcher at <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/">the FDA</a>, says nothing like it has ever existed between major US blood centers and the government.</p><p>"It's giving us timely, accurate data regarding risks to blood safety," Walderhaug told Tech Insider. "We could only guess at those before."</p><p><em>Learn to protect yourself from tick-borne diseases with resources from the <a href="http://www.fda.gov/forconsumers/consumerupdates/ucm358486.htm">FDA</a> and <a href="http://www.cdc.gov/features/lymedisease/">CDC</a>, and learn about the value of donating blood at the <a href="http://www.redcrossblood.org/donating-blood/why-donate-blood">American Red Cross</a>.</em></p>

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