{"id":51752,"date":"2022-12-08T20:02:06","date_gmt":"2022-12-08T19:02:06","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/c2n-diagnostics-precivityad-and-precivityad2-blood-tests-at-ctad-2022-highlight-the-potential-and-use-of-blood-based-biomarkers-in-the-diagnosis-of-alzheimers-disease\/"},"modified":"2022-12-08T20:02:06","modified_gmt":"2022-12-08T19:02:06","slug":"c2n-diagnostics-precivityad-and-precivityad2-blood-tests-at-ctad-2022-highlight-the-potential-and-use-of-blood-based-biomarkers-in-the-diagnosis-of-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/c2n-diagnostics-precivityad-and-precivityad2-blood-tests-at-ctad-2022-highlight-the-potential-and-use-of-blood-based-biomarkers-in-the-diagnosis-of-alzheimers-disease\/","title":{"rendered":"C2N Diagnostics\u2019 PrecivityAD\u00ae and PrecivityAD2\u2122 Blood Tests at CTAD 2022 Highlight the Potential and Use of Blood-Based Biomarkers in the Diagnosis of Alzheimer\u2019s Disease"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<i>Neurologists and Memory Care Specialists Better Able to Evaluate and <\/i><i>Change Medical Management of Patients with Cognitive Impairment Using C<sub>2<\/sub>N<\/i><i> Diagnostics\u2019 PrecivityAD\u00ae Blood Test, New Research Shows<\/i>\n<\/p>\n<p class=\"bwalignc\">\n<i>Additional Research Findings Confirm Excellent Performance of the PrecivityAD2\u2122 Blood Test and p-tau217 Ratio Test in Screening High Risk Individuals for Entry into Clinical Trials<\/i>\n<\/p>\n<p>ST. LOUIS&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/Alzheimers?src=hash\" target=\"_blank\" rel=\"noopener\">#Alzheimers<\/a>&#8212;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.c2n.com%2F&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=C2N+Diagnostics&amp;index=1&amp;md5=ce6a1b5a89517926bba296fb7ee093ae\" rel=\"nofollow noopener\" shape=\"rect\">C<sub>2<\/sub>N Diagnostics<\/a>, LLC (\u201cC<sub>2<\/sub>N\u201d) provided today a recap of the multiple presentations at the 15<sup>th<\/sup> Clinical Trials on Alzheimer\u2019s Disease (CTAD) Congress, November 29 \u2013 December 2, 2022, in San Francisco, highlighting the clinical utility and performance of the company\u2019s blood-based biomarkers for the evaluation of patients with cognitive impairment.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221208005796\/en\/1659816\/5\/Picture1.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221208005796\/en\/1659816\/21\/Picture1.jpg\"><\/a><\/p>\n<p>\n<b>Findings Highlight How Patients Benefited from PrecivityAD\u00ae Blood Test Results<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fprecivityad.com%2F&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=PrecivityAD%26%23174%3B&amp;index=2&amp;md5=2f5dff404ac5f14e742f567b7aef005a\" rel=\"nofollow noopener\" shape=\"rect\">PrecivityAD\u00ae<\/a> blood test is bolstered by new research that found the test provided clinically informative results in approximately 85% of cases.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nNeurologists and other memory care specialists reported they were more confident to rule-in or rule-out a diagnosis of clinical AD based on the PrecivityAD\u00ae blood test result.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nThese clinicians also frequently used the blood test result to guide their treatment plans.\n<\/li>\n<\/ul>\n<p>\nThe PrecivityAD\u00ae blood test showed clinical utility in medical decision-making around diagnostic certainty and drug therapy management for 347 patients aged 60 years or older who were under evaluation for mild cognitive impairment or dementia.\n<\/p>\n<p>\nThe study (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT05477056&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=NCT05477056&amp;index=3&amp;md5=289f34cb9c334886bec137e831157f10\" rel=\"nofollow noopener\" shape=\"rect\">NCT05477056<\/a>) found that most memory care specialists among the 43 providers who participated made patient care decisions once they received a patient\u2019s Low or High Amyloid Probability Score (APS) from the PrecivityAD\u00ae blood test. APS represents the estimated likelihood from 0 (low likelihood) to 100 (high likelihood) that the patient has amyloid plaques in the brain, which in this context, is consistent with an AD diagnosis.\n<\/p>\n<p>\nIn the study, likelihood of clinical AD in patients with a Low APS decreased on average from 58% (pre-test) to 23% (post-test)(p&lt;0.0001). Likelihood of clinical AD for patients with a High APS increased on average from 71% (pre-test) to 89% (post-test)(p&lt;0.0001). While the PrecivityAD\u00ae test results did not influence overall usage rates of Alzheimer\u2019s directed therapies when examining the entire 347 patients as a single cohort (52% pre-test vs. 57% post-test, p=0.25), the test significantly influenced treatment appropriateness within the different APS likelihood categories. Patients in the Low APS category went from a reported treatment usage rate of 48% (pre-test) to 26% (post-test) for a 46% relative decrease (p&lt;0.0001). Patients in the High APS category went from a treatment usage rate of 52% (pre-test) to 88% (post-test) for a 57% relative increase (p&lt;0.0001).\n<\/p>\n<p>\nAs an example of the benefit derived from using the PrecivityAD\u00ae blood test, one neurologist in the study reported that they would \u201cnever have been able to determine amyloidopathy in this complicated patient without biomarker testing.\u201d\n<\/p>\n<p>\nThe findings are part of the Quality Improvement PrecivityAD\u00ae (QUIP I) Clinician Survey, one of the first clinical utility studies examining real world impact of a blood-based biomarker test for aiding in AD diagnosis and management.\n<\/p>\n<p>\n\u201cThese findings are important because the current standard of care in the diagnostic evaluation of patients with mild cognitive impairment and dementia are poorly correlated with AD pathology of brain amyloidosis. Using current standard tools, this can lead to misdiagnosis rates of 30\u201350%. The data from C<sub>2<\/sub>N\u2019s QUIP I study shows that even among experienced memory care specialists, considerable uncertainty exists in an AD diagnosis without the use of a disease biomarker,\u201d stated Dr. Joel Braunstein, C<sub>2<\/sub>N\u2019s president and CEO. \u201cUsing a clinically and analytically validated blood test like the PrecivityAD\u00ae test, providers became considerably more confident to make a diagnosis and changed their prescribing practices to align with the post-test likelihood of AD.\u201d\n<\/p>\n<p>\n<b>Studies Back Up the Strong Performance of C<sub>2<\/sub>N\u2019s New PrecivityAD2\u2122 Blood Test and Use of the p-tau217 Ratio to Identify Early Tau Pathology<\/b>\n<\/p>\n<p>\nAdditional Late-Breaking results presented at CTAD 2022 support the usefulness of the PrecivityAD2\u2122 blood test, which is C<sub>2<\/sub>N\u2019s <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnam11.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fwww.businesswire.com%252Fnews%252Fhome%252F20221129005757%252Fen%252FC2N-Diagnostics-Introduces-the-PrecivityAD2%2525E2%252584%2525A2-Blood-Test%26data%3D05%257C01%257Cadam.shapiro%2540aspr.bz%257Cf8d8080e7f524fdcc47108dad8abf6cb%257Ca85cfc0268f54339b4c4abd1a2e2e6dc%257C0%257C0%257C638060530926490996%257CUnknown%257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%253D%257C3000%257C%257C%257C%26sdata%3D3iW1cgb%252FMz7YoGZT5lDN97ylE7BYxZyf16D%252FPbNuUJU%253D%26reserved%3D0&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=next-generation+blood+test&amp;index=4&amp;md5=31f04d3657dd236e0079831a544fcf68\" rel=\"nofollow noopener\" shape=\"rect\">next-generation blood test<\/a> to aid in the detection of brain amyloid and tau in the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.AHEADStudy.org&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=AHEAD+Study+clinical+trial&amp;index=5&amp;md5=2741a022cabb247bdf92369e59285908\" rel=\"nofollow noopener\" shape=\"rect\">AHEAD Study clinical trial<\/a>, based in part on precise measurements of phosphorylated (p) and non-phosphorylated (np) fragments of the tau protein: p-tau217\/ np-tau217 ratio.\n<\/p>\n<p>\nDr. Keith Johnson, Professor of Radiology at the Harvard Medical School and Associate Radiologist and the Director of Molecular Neuroimaging in the Division of Nuclear Medicine and Molecular Imaging (Department of Radiology) at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04468659&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=the&amp;index=6&amp;md5=d52779179546b5e2b33fb8cad931379b\" rel=\"nofollow noopener\" shape=\"rect\">the<\/a> Massachusetts General Hospital (MGH), presented findings on behalf of the AHEAD 3-45 investigators. The data presented showed that\n<\/p>\n<p>\nC<sub>2<\/sub>N\u2019s plasma p-tau217 ratio measure is useful for identifying individuals with evidence of tau tangle pathology prior to the appearance of Alzheimer\u2019s symptoms.\n<\/p>\n<p>\nIn a cohort of 303 cognitively unimpaired individuals who were already deemed amyloid eligible based on a positive amyloid PET from the AHEAD 3-45 screening protocol, plasma p-tau217 ratio was significantly associated with regional tau deposition in the brain at the early (medial temporal allocortex, MTL) and mid-stages (Neocortex) of AD tauopathy (Pearson correlation = 0.43, p&lt;0.0001), as measured by Tau PET imaging. Based on these data, and subject to more research, plasma p-tau217 ratio may be useful for identifying individuals with evidence of tau pathology, even before the onset of AD clinical symptoms.\n<\/p>\n<p>\nDr. Robert Rissman, Professor of Physiology and Neuroscience at the University of Southern California (USC) and Neurosciences at University of California, San Diego (UCSD) and Director of the Alzheimer\u2019s Clinical Trials Consortium (ACTC) Biomarker Unit, also on behalf of the AHEAD study team reported data from 1,085 cognitively normal people. The data presented showed that a developed algorithm that combines plasma levels of A\u03b242\/40 and the p-tau217 ratio, as measured with C<sub>2<\/sub>N\u2019s mass spectrometry-based assays, can detect brain amyloid PET accumulation &gt; 90% accuracy in individuals prior to the onset any AD symptoms. In the context of enrolling individuals for participation in AD treatment or prevention studies, Dr. Rissman suggested that using the combination of plasma p-tau217 ratio and A\u03b242\/40 ratio can greatly shorten study timelines by improving participant enrollment efficiency, reduce participant burden, eliminate unnecessary PET scans, and save costs.\n<\/p>\n<p>\n\u201cWe are grateful for our collaboration with many scientific colleagues present at this year\u2019s CTAD,\u201d Dr. Braunstein added. \u201cCombined with the remarkable altruism of the study participants who made the new findings from this meeting possible, we are learning important insights and building community knowledge around the transformative potential of blood-based biomarkers in AD clinical research and patient care.\u201d\n<\/p>\n<p>\n<b>About C<sub>2<\/sub>N Diagnostics, LLC<\/b>\n<\/p>\n<p>\n<i>C<\/i><i>\u2082<\/i><i>N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation\u00ae. C<\/i><i>\u2082<\/i><i>N strives to provide exceptional laboratory services and products in the field of brain health. C<\/i><i>\u2082<\/i><i>N\u2019s biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer\u2019s Drug Discovery Foundation, BrightFocus Foundation and Alzheimer\u2019s Association. For more information visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.C2N.com&amp;esheet=53029942&amp;newsitemid=20221208005796&amp;lan=en-US&amp;anchor=www.C2N.com&amp;index=7&amp;md5=0b81c57709a585d49090370d805661f2\" rel=\"nofollow noopener\" shape=\"rect\">www.C2N.com<\/a>.<\/i>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<i>COMPANY<\/i>:<br \/>\n<br \/>Joni Henderson<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#x69;&#x6c;t&#111;&#x3a;&#x6a;h&#101;&#x6e;&#x64;e&#114;&#x73;&#x6f;n&#64;&#x63;&#x32;n&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#106;&#x68;e&#110;&#x64;e&#114;&#x73;o&#x6e;&#x40;&#99;&#x32;n&#46;&#x63;o&#109;<\/a><br \/>314-464-0009\n<\/p>\n<p>\n<i>MEDIA<\/i>:<br \/>\n<br \/>Adam Shapiro<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#105;&#x6c;&#x74;&#x6f;:A&#100;&#97;&#x6d;&#x2e;&#x53;h&#97;&#112;&#105;&#x72;&#x6f;&#x40;A&#83;&#80;&#x52;&#x2e;&#x62;z\" rel=\"nofollow noopener\" shape=\"rect\">&#65;d&#x61;m&#x2e;&#83;&#x68;&#97;&#x70;&#105;r&#x6f;&#64;&#x41;&#83;&#x50;&#82;&#x2e;&#98;&#x7a;<\/a><br \/>202-427-3603\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Neurologists and Memory Care Specialists Better Able to Evaluate and Change Medical Management of Patients with Cognitive Impairment Using C2N Diagnostics\u2019 PrecivityAD\u00ae Blood Test, New Research Shows Additional Research Findings Confirm Excellent Performance of the PrecivityAD2\u2122 Blood Test and p-tau217 Ratio Test in Screening High Risk Individuals for Entry into Clinical Trials ST. 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