{"id":57872,"date":"2021-09-20T06:06:18","date_gmt":"2021-09-20T06:06:18","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=79076"},"modified":"2021-09-20T06:06:18","modified_gmt":"2021-09-20T06:06:18","slug":"fda-clears-first-technology-to-distinguish-between-bacterial-and-viral-infections-using-the-bodys-immune-response-the-memed-bv-test-and-memed-key-platform","status":"publish","type":"post","link":"https:\/\/lebanonnewsgazette.com\/fda-clears-first-technology-to-distinguish-between-bacterial-and-viral-infections-using-the-bodys-immune-response-the-memed-bv-test-and-memed-key-platform\/","title":{"rendered":"FDA Clears First Technology to Distinguish between Bacterial and Viral Infections Using the Body\u2019s Immune Response \u2013 The MeMed BV\u00ae Test and MeMed Key\u00ae Platform"},"content":{"rendered":"<div>\n<p align=\"center\"><strong>FDA <\/strong><strong>Clears<\/strong> <strong>First <\/strong><strong>Technology <\/strong><strong>to<\/strong> <strong>Distinguish between Bacterial and Viral Infections <\/strong><strong>Using <\/strong><strong>t<\/strong><strong>he <\/strong><strong>Body\u2019s <\/strong><strong>Immune Response <\/strong><strong>\u2013<\/strong><strong> The <\/strong><strong>MeMed <\/strong><strong>BV<\/strong><strong>\u00ae Test and MeMed Key\u00ae Platform<\/strong><\/p>\n<ul type=\"disc\">\n<li><em>MeMed <\/em><em>BV<\/em> <em>is a first-of-its kind <\/em><em>test<\/em> <em>that decodes the immune response<\/em><em> to <\/em><em>accurate<\/em><em>ly <\/em><em>distinguish between <\/em><em>bacterial or viral infection<\/em><em>s<\/em><em> within minutes<\/em><\/li>\n<li><em>MeMed Key is a <\/em><em>pioneering<\/em><em> platform <\/em><em>that enables <\/em><em>rapid and <\/em><em>sensitive measurements of multiple proteins at the point-of-need<\/em><\/li>\n<li><em>The MeMed technology suite enables better informed antibiotic treatment decisions<\/em><em>,<\/em> <em>a<\/em><em>n<\/em> <em>essential <\/em><em>tool in the fight against the <\/em><em>global <\/em><em>threat of resistant bacteria<\/em><\/li>\n<\/ul>\n<p><strong>HAIFA, Israel<\/strong><strong>, Boston, MA;<\/strong> <strong>September 20th<\/strong><strong>,<\/strong> <strong>202<\/strong><strong>1<\/strong> \u2013 MeMed, a leader in the emerging field of advanced host-response technologies, today announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the MeMed BV\u00ae test on the point-of-need platform MeMed Key\u00ae to help healthcare providers distinguish between bacterial and viral infections. The technology has been cleared for both children and adults.<\/p>\n<p>Bacterial and viral infections are often clinically indistinguishable, leading to the prescription of antibiotics for the treatment of viral infections, for which they are ineffective. Antibiotic misuse drives the emergence of antimicrobial resistance (AMR), one of the biggest healthcare challenges of our time.<br \/>\nThe novelty of MeMed\u2019s technology is that it decodes the body\u2019s immune response to infection, the \u2018host response\u2019, rather than focusing on detecting the presence of a microbe. This allows robust diagnosis\u00a0when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests, or when the cause of infection are emerging new pathogens. It enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria.<\/p>\n<p>\u201cFor those of us who care for acutely ill children, we have been waiting decades for accurate, rapid diagnostics to confidently guide the care of moderately ill children without a clear focus of infection or recognizable viral illness. This novel test offers promise to help differentiate those children with self-limited viral illness from those with possible bacterial infection, thereby supporting the judicious use of antibiotics,\u201d <strong>said<\/strong><strong> Rich Bachur, MD, Professor of Pediatrics and Emergency Medicine, Harvard Medical School, and Chief, Division of Emergency Medicine, Boston Children&#8217;s Hospital.<\/strong><\/p>\n<p>\u201cIt has been a decade long journey to reach this point from concept to impacting patient lives,\u201d <strong>said <\/strong><strong>Dr. <\/strong><strong>Eran Eden, <\/strong><strong>MeMed\u2019s<\/strong><strong> co-founder and CEO<\/strong><strong>. <\/strong>\u201cThis FDA clearance is a breakthrough moment in the field of advanced host-response and could not have been achieved without the dedication of the MeMed team, our clinical partners in the US and around the globe, and the support of the US Department of Defense and EU Commission.\u201d<\/p>\n<p><strong>Sergey <\/strong><strong>Motov<\/strong><strong>, MD, Professor of Emergency Medicine, Maimonides Medical Center<\/strong><strong>, New York, said<\/strong><strong>:\u00a0<\/strong>\u201cHost-response technologies are a new frontier in the management of patients with infectious diseases, with great potential to improve patient outcomes. Every day, I see adults with a complicated\u00a0medical history presenting to the emergency room with a suspected respiratory tract infection. A technology like MeMed BV can significantly aid in their management.\u201d<\/p>\n<p>\u201cWe are\u00a0now\u00a0using\u00a0MeMed BV in my department routinely\u00a0to aid\u00a0in determining whether a child with fever has a bacterial or viral infection.\u00a0For example, we\u00a0recently\u00a0had a complicated\u00a0case of a young child with fever but without a clear source. MeMed BV helped in early identification of a severe bacterial infection, that would otherwise be masked by viral PCR detection, lead to a change in the course of treatment, and made a big difference in the patient\u2019s outcome,\u201d <strong>said\u00a0Dr Adi Klein, Director of <\/strong><strong>the <\/strong><strong>P<\/strong><strong>ediatric <\/strong><strong>D<\/strong><strong>ivision, Hillel <\/strong><strong>Yaffe<\/strong><strong>\u00a0Medical\u00a0Center\u00a0and\u00a0Head of the Israeli Clinical Pediatric Society. <\/strong>\u201cIntroducing MeMed\u2019s technology has had a significant impact on our\u00a0medical practice, enabling\u00a0us to be better stewards of antibiotics\u00a0and improving patient outcomes.\u201d<\/p>\n<p>FDA clearance was based on a multi-center blinded clinical validation study enrolling over 1,000 children and adults and addresses goals laid out in the US <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3D_0gJ3FhuVB_quv35pNhZgBoY3uAeVh18YxIRPMEGNRJ6HH-LADeYnxLP1rIeVoqNc3_yzJg8VTEO6__zAmU4dl96h0ZBI-_L2LXLrhyK7ZglQDiR-WrN4mj12dLwh30ZPMF072BIgg5ASRStuIQZJF5QYlGZjr9AC0wEgGC78yfN7ORyc2_2-RY_aPe2a1V1NIeMOJb2b3Z79l2ZSPJJpQ%3D%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGn_q8D_s346bQspqwZMcFgM7LLNw\"  rel=\"nofollow noreferrer\">National Action Plan <\/a><a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DINzCc4-BvgRVMhHj70FFyUJ2aK8jItTWQwqiAiljCTDCQJFPpAdkGF-oTR4rWslaEuiG39EspX_K0wnIfqIL8obaf_Z7--_INwlcEoXW30GQMAjOrf7ke_mWEeKI9qZJa3KyNwqBtM-X7iFHtgo4-6KV29PTHZ-RGiU3dN4XfLEug34qJrt77egkgk3BCap8&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNFCVSX1lCu7X9WDnOXOuoLdhWuvOA\"  rel=\"nofollow noreferrer\">for<\/a><a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DqJzCSNNDXGIi6YS4jOXFoniF-cZYx0cYspZwmyTZ9_9ZCvvbjGqTqfVNSUAUwiMx-Vi29pBb0PDSP1lvcwYW9r75CV4xPtLU1VZo4L6kWCUxtL45J8ue0Bcc7OznDdjmf2QarV9O0D1xKaGVn1a8PoPMxsb7i9PKD8LBT23igVdODgjK_b0RL9ntttzXDcrG&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGiKYfJbrdqXIbFyoVKePJ6zWB6sA\"  rel=\"nofollow noreferrer\"> Combat<\/a><a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3D0MtvHVRJVpKJoPdG6Lci3i38qIiloxXDWseA-0Gw4u9c8fNpgQ5JCREZ1_Oc22Vq_vDIHDFd7i5PQy0RIrI3BdmBQfPQCxzWylkDp8F1DB6TiEuhaazgEr9lgZ6b4nbXP2jUr5fMX0-GOcO5sEVeauVgA5uSFaTQKiiJD_OODiLX9PJLrlMqYRuuMcjV4GyK64geffDkAm_eUJhnej_xK-nwzp_MwmXVzgcj52NVfoU%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNHOGBHtmLEcEI10YkJpXF5--2-dAA\"  rel=\"nofollow noreferrer\">ing Antibiotic Resistant Bacteria<\/a>. The test provides highly accurate results with Area Under the Curve of 90% and 97% (primary and secondary endpoints). MeMed has established its US base in Boston and is ramping up commercial activities to ensure broad availability of its products across the US.<\/p>\n<p><strong>About MeMed <\/strong><br \/>\nOur mission is to translate the immune system&#8217;s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. To learn more about MeMed and our solutions, please visit <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DCFQ-iqatUlmY8p6XoEBsZZTVAdomYh8tHRTzGJUo5YzwQdoLKqBOdc5h-JuZIBSRHHyxRnhM8TIOIaVGt6U_D5fKWHai_n7jnpBsDD95hp0%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNF6yBUHYSmzXq2mVAFR-jXm_dUoGA\"  rel=\"nofollow noreferrer\">http:\/\/www.me-med.com<\/a><\/p>\n<p><strong>About MeMed BV<\/strong><strong>\u00ae<\/strong><br \/>\nMeMed BV<strong>\u00ae<\/strong> is a first-of-its-kind immune-based protein signature test, developed and validated over the course of decade-long collaborations with leading academic and commercial partners. It provides physicians with an indispensable tool to help distinguish between bacterial and viral infections across multiple pathogens, even if the infection site is inaccessible or unknown.\u00a0MeMed BV<strong>\u00ae<\/strong> measures and computationally integrates the levels of three immune system proteins: TRAIL, IP-10 and CRP. When run on the MeMed Key\u00ae platform, MeMed BV\u00ae provides a result within 15 minutes. MeMed BV<strong>\u00ae<\/strong> has been independently validated on thousands of patients and the results have been published in leading peer-reviewed journals (including\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DsKxM4Dls445W1a06QCAlLhFZaLf931oiWKpL01Gapme_IOqRGoX3YvXc-J2MkhD1F5NyizNhTDuUTehh7yM3c_oPz2jRO-SGrHHMMYztWQAM9xb4rola38bPOFPYvNd_j92tWiVUBarCHdXf2TBGog%3D%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNFNsafCc9CPeSx5wOEhmuEYTAg8xQ\"  rel=\"nofollow noreferrer\">Pediatrics<\/a>,\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DvBqf0TGvG4Oi7VBA90UjhlSVzlYf9vNZWygLWDEaudanGj71fkdmdNk-VzT8iGy2LxcZy2CaKj7-Bx6djmEQILK3v6WzTfv2Pioama0bBaz2G5XDAO7J31cY5BcSB6GI3XNqU3RrIrA0LIMZUbHzuALKU_jPfZMl3hEQPWO4uBk%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNH2r9lSjssw0y9oY0kfZiJP0JP9qA\"  rel=\"nofollow noreferrer\">The Lancet ID<\/a>,\u00a0\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DcEh3z25hxCZHtR67qsQAdYlBB-CkfpkWXGoXsmKaEM5ii0DI-To6Zjvq27dWuAVxtO9y5suTDEZwpw7ssAVki0nhqaO10LgIahhltGeVZn1BGXtDurti5ycmzh7iP3L8Krje7Zlt1DgMATaHRPMcsg%3D%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGE4asHBjRAltnj_donMtVgJKUzWQ\"  rel=\"nofollow noreferrer\">PLOS One<\/a>,\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DIEb1CKM3EyokrB8G6am_PWRQUfhXen0-P0P600AAVpkCuuTspA5SNAcYl4gDucRfTWO0cEhW9cg-Dp_1X1z7wliAwnv75IIMQExmwAO48EFxLGV488Pyn908VPByXJCz&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGGNQmp1ous6W5C51Ol686Ur8uvNQ\"  rel=\"nofollow noreferrer\">BMJ Peds<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Dzm5zhVFgx2O5n3t4wip4ucEjKQceLtg90s6_4xixi9u_eJiC-3UQs4dWTXqtH3t90lwVroqEyju5LoDWraDIel5FELIB--DR_I_MtWzhYH-5xc_Fl9GGzkGmAbt2DkB-iPEvk0lBi_zLYjVRdgR8emZown4Qe2ef6qxAdjhA4rJsum3w-ZArKf6Bxy1KmKLXZhAydeWCKjNJawmHzg_nm96CrrZ2_BeuEDG6ZS08KDo3IRAm_g1IAxx0OGJE1Pnqk6TFkngazZgVGiEi1ctGM-PhF8xDSoES1-2RhNxGmCERudRyJOrwdwjturCoVrYd_Ab9fU-eGfsVXlUAYi6SJoTZnZ5xgE3e1RseHCw2nw7mRXdHFkXX1PUnLBHp7NfSM8X-ybv36rGKdHQ5G2MQxRYxP7Vd5qUbBU4JkHKIf85S436R6E6uvPC29EFCgD5z&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNEzoL3BjVqjNy6ICdjnbKibLuhsnw\"  rel=\"nofollow noreferrer\">European Journal of Clinical Microbiology &amp; Infectious Diseases<\/a>). The MeMed BV\u00ae test has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.<\/p>\n<p><strong>About MeMed Key<\/strong><strong>\u00ae<\/strong><br \/>\nMeMed Key<strong>\u00ae<\/strong> is a pioneering technology platform, enabling highly sensitive measurements of multiple proteins, within minutes, at the point of need. It opens the way to quantification of a vast array of human proteins in healthy and disease states, where and when it actually matters. The MeMed Key<strong>\u00ae<\/strong> development program has been partially funded by the US Department of Defense and the EU Commission. MeMed Key<strong>\u00ae<\/strong> has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.<\/p>\n<p><strong>MeMed Contacts:<\/strong><br \/>\nAdee Mor, VP Marketing, MeMed<br \/>\n<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DKmXpWpVtAMyFORFvHs9NeeGUq6-dFfzq5VhwbGUUP9Vd17Mc3kivZJdllUdpBvreeMs-I9K3rJNdGCn2daNMJw%3D%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGWLIoJFK4tVq9Q_CR8cULl_Bh1Og\"  rel=\"nofollow noreferrer\"><u>pr@me-med.com<\/u><\/a><br \/>\nKfir Emmer, CFO, MeMed<br \/>\n<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DXDBDTLfeMG2iaHvJp2TGVtdKWHI_35zBxa89tdwDGrPI6cKR-zqWwYhB2MIePge5wRD4qnQiobdVw8elBDMnmIXTjlBzMGrZvfu0gH202kM%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNEe2Sr9DC-Vf3tV-Eg_68GKVqm0Cg\"  rel=\"nofollow noreferrer\"><u>kfir.emmer@me-med.com<\/u><\/a><\/p>\n<p><strong>Media relations contact:<\/strong><br \/>\nConsilium Strategic Communications <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Dk1eW02RY9mci-PS0F4Z3j0IXhAQJoHtEqojFAovIpkk7JOLov5RKHd__C7vFpGVXTZDAk1qSNBE0-x3CeuCqMMlBPtVx5df6BH4QUpGTciOuGxHTWHRK9628v2l7Pal8&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGp9sh-nNsnlE_IlEjFA5L3aN8hNQ\"  rel=\"nofollow noreferrer\">MeMed@consilium-comms.com<\/a><\/p>\n<p>Please click <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DnUpJUViQRHTlZjUA8d9ukKnSvs0qYJ7le3z-0HPlQyo5cxKts8mwkfHVNRqeDdohck32rm7ilHssl3z4uixzoOA8Kv3iALCqdJQwOpTwjpdEEYXVEQXUM_9YL1PBZLBP662oq2o0Jie2tuKXDBbWmQ%3D%3D&amp;source=gmail-html&amp;ust=1632204317837000&amp;usg=AFQjCNGtIMXmaXrYPd-po7kjv7RS-eb_zw\"  rel=\"nofollow noreferrer\"><strong>here<\/strong> <\/a>to see the full release in Hebrew<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA Clears First Technology to Distinguish between Bacterial and Viral Infections Using the Body\u2019s Immune Response \u2013 The MeMed BV\u00ae Test and MeMed Key\u00ae Platform MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes MeMed Key is a pioneering platform that enables [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[182,17,53,343],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.6 - 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