Clinical OMICS

MAR-APR 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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18 Clinical OMICs March/April 2018 www.clinicalomics.com Diagnostics MeMed Wins $4.1M DOD Grant toward Manufacturing of POC Platform MeMed has won a $4,079,159 grant from the U.S. Department of Defense (DOD) to support transition of the company's prototype ImmunoPoC point-of-care (POC) blood-testing platform toward a final product, including transfer to man- ufacturing and implementation of cloud connectivity. The grant from the DOD's Congressionally Directed Medical Re- search Programs (CDMRP) complements a $9.2 million contract from the DOD's De- fense Threat Reduction Agency awarded in April 2017 to MeMed, with the goal of supporting the final stages of prototype development. ImmunoXpert, the company's lead product, is designed to measure three blood-borne immune markers to accu- rately detect whether a patient has a bacterial or viral infection, with the goal of better informing physician decisions on antibiotic treatment. The prototype is for a POC test designed to provide results within minutes—a second-generation version of MeMed's first-generation Im- munoXpert test. ImmunoXpert is cleared for clinical use in the EU, where it is CE-IVD certified; as well as in Switzerland and Israel. Im- munoXpert is now in pilot distribution in these areas with a broader commer- cial roll-out underway, MeMed said. "This grant will allow us to set up manufacturing processes for our POC platform, ultimately enabling MeMed's novel blood test that has been clinical- ly validated for differentiating between bacterial and viral infection to reach the patient in a shorter time," MeMed CTO Kfir Oved, M.D., Ph.D., said in a statement. n Cognoa Wins FDA Class II Designation for AI-Based Autism Diagnostic Cognoa said that its artificial intelligence (AI)-based software platform for behav- ioral health conditions has received the FDA's Class II diagnostic medical device designation for autism. The designation will expand its ability to offer its solution to enterprise customers, healthcare pay- ers, and directly to clinicians in primary care settings. In a study published by Stanford re- searchers February 12, 2018, in the Journal of Autism and Developmental Disorders, the electronically administered, seven-ques- tion autism spectrum disorder (ASD) screen showed 89.9% sensitivity and 79.7% specificity in detecting ASD. "In a high-risk clinical setting, the MARA [Mobile Autism Risk Assessment] shows promise as a screen to distinguish ASD from other developmental/behavioral disorders." Cognoa's platform has been clinically validated to identify autism in children as early as 18 months of age. While ASD can be diagnosed as early as age two, most children are not diagnosed with ASD until after age four, according to the U.S. Cen- ters for Disease Control and Prevention (CDC). n cancers, and individuals with inflam- matory diseases that increase pro- tein levels could increase the rate of false-positive results. "[CancerSEEK] needs to be validated in a large pro- spective study on healthy individuals to see exactly what the sensitivity and specificity is in that cohort," explained Lennon. Such a study is currently underway at Geisinger Health System. Geisinger has initiated the first, 18-month phase of the study, which will enroll 10,000 women between the ages of 65 and 75 with no previ- ous history of cancer. If the first phase goes well, the DETECT study plans to enroll an additional 40,000 partici- pants in a 5-year, $50 million research initiative funded by the Marcus Foun- dation, a private philanthropic group. Participants with two positive test results will undergo additional testing to identify and treat potential tumors. According to Adam Buchanan, assis- tant professor, who is leading the research at Geisinger, one of the most important and challenging aspects of the study is "making that clinical handoff from a research endeavor to a clinical endeavor for those who are eventually found to have can- cer." In addition to evaluating how participants react to test results, the DETECT study will also assess how well CancerSEEK detects different stages of cancer. Early detection could turn the tide in the war on cancer for many individ- uals, but, despite CancerSEEK's prom- ising results, the search for oncology's "holy grail" is far from over. However, as Dr. Schiffman told NPR, "This is the paper that's going to set the field in motion." (continued from previous page) Imgorthand / Getty Images sdominick / Getty Images

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