Emily Hayesehayes@labpulse.comCollaborationCan a new national forum bust roadblocks to laboratory testing for COVID-19?Through the new forum, stakeholders may provide feedback to national leaders, with the goal of fostering innovation and expanding access to testing for the U.S. public, the HHS explained in a July 21 statement. Admiral Dr. Brett Giroir, assistant secretary for health and member of the White House Coronavirus Task Force, is leading the new initiative.July 21, 2020Colorectal CancerMailing FIT kits to Medicaid patients could boost colon cancer screening ratesUsing results from a randomized trial, the study simulated the costs and benefits associated with mailed FITs with prepaid return envelopes compared with a mailed reminder alone for colon cancer testing in a population of 35,000 Medicaid patients overdue for screening. Looking over a year, researchers concluded that the anticipated number of colorectal cancer (CRC) screenings, including FIT and colonoscopies, would be higher for the group that had the fecal tests mailed directly (23.2%) than those just getting mailed a reminder about the need for screening (15.8%).July 20, 2020InfectiousRapid testing, diagnosis is essential for reining in coronavirusIn a study involving mathematical modeling, researchers examined scenarios around transmission, contact tracing, timing of testing, and isolation of people who have been infected. Currently, it is thought that about 40% of transmission is from people who are asymptomatic. It is crucial to isolate an index case and carry out testing of potentially affected people in less than three days, the study found.July 19, 2020Emergency Use AuthorizationU.S. nursing homes gear up for coronavirus antigen testing at point of careThe U.S. Department of Health and Human Services (HHS) on July 14 announced plans for a one-time procurement of point-of-care antigen testing equipment, which will be distributed to long-term care facilities to enable onsite assessment. In a statement about the plan, the HHS noted that the equipment will be cleared by the U.S. Food and Drug Administration. Currently, two antigen testing products have an emergency use authorization -- Becton Dickinson's Veritor system and Quidel's Sofia 2 unit.July 16, 2020InfectiousPathologists shortchanged in workforce data | Universal testing in nursing homes | Neurofilament blood test comes of age in concussionDear LabPulse Member,July 16, 2020AccreditationPathologist workforce data miss the mark, need revisionThe study was sponsored by the College of American Pathologists (CAP) and followed up on an article with workforce data published in JAMA Netw Open in May 2019. Alarmingly, that study concluded that the number of active pathologists dropped from 15,568 to 12,839 between 2007 and 2017, a trend that suggested great risk for a shortage of specialists in the field in the future. These data were based on information published by the American Association of Medical Colleges (AAMC), which in turn drew from the American Medical Association (AMA) Physician Masterfile.July 16, 2020Research and DevelopmentEvidence builds for neurofilament light blood test in brain injury patientsThe authors of the study, which was funded by the NIH and the U.S. Department of Defense (DOD), see the results as an encouraging step for the development of serum NfL as a noninvasive biomarker and potential alternative to NfL in cerebral spinal fluid (CSF) for the assessment of TBIs. Researchers published prospective experience with two cohorts: 45 hockey players with acute concussion treated in Sweden, and 230 TBI patients and healthy controls at the NIH's Clinical Center, a research hospital in Bethesda, MD.July 14, 2020Point-of-Care TestingWeek in Review: Getting to know COVID-19 | Biomarkers for preeclampsia, liver disease | Quest puts HPV/Pap cotesting to the testDear LabPulse Member,July 9, 2020InfectiousWHO clarifies coronavirus transmission, launches review of world responseThe WHO published a scientific brief on transmission in a question and answer format on the organization's website July 9. Ideas about transmission have been evolving and at times confusing, following comments by the WHO that asymptomatic transmission was rare and with scientists speaking out on aerosol (airborne) transmission in indoor settings, such as restaurants and churches, and urging the WHO to address this risk.July 8, 2020Molecular DiagnosticsFDA provides guidance on pooling to boost coronavirus test throughputRecommendations for labs and manufacturers on SARS-CoV-2 molecular diagnostics to be used for pooling of samples were included in a section on EUAs for IVD on the agency's website that was updated July 6. Pooling is one of the creative solutions labs have used to scale up amid a shortage of testing-related products. Combining individual samples into pools that can be tested together can save supplies, greatly boost efficiency, and works well in scenarios where there is a presumption of many negative samples.July 7, 2020Previous PagePage 2 of 27Next PageTop StoriesRegulatory ApprovalSeegene obtains IVDR certification for 30 diagnostic assaysThe newly certified assays include eight for gastrointestinal infections, seven for women's diseases, five for respiratory diseases, four for tuberculosis, three for meningitis, two for human papillomavirus (HPV), and one for drug resistance.Policy and RegulationAdvocacy groups in letter urge FDA to develop regulations for lab-developed testsCollaborationNucleai, Adlai Nortye collaborate on biomarkers for clinical trialsCOVID-19Long COVID symptoms reported by 17% of unvaccinated peopleSponsor ContentVisit our Molecular Diagnostics Community
