Brian Caseybcasey@auntminnie.comModerate Complexity TestHHS: FDA review not needed for coronavirus LDTsIn the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.August 19, 2020InfectiousAACC says December meeting will be all-virtualIn an email to members, AACC said the group's board of directors had made a "pivotal decision" to hold the annual meeting entirely as a virtual event. AACC 2020 will continue to be held December 13-17, the same dates as the in-person meeting.August 18, 2020LawsuitFeds arrest president of blood testing firm on fraud chargesMark Schena was arrested on charges that he and Arrayit allegedly misled investors, manipulated the company's stock price, and conspired to commit healthcare fraud by submitting over $69 million in fraudulent claims for allergy and COVID-19 tests. The arrest was announced in a June 9 press statement by the U.S. Attorney's Office for the Northern District of California.June 9, 2020PCRWhat are the risks of false-negative COVID-19 tests?In the article, the authors maintain that the sensitivity and other aspects of reverse transcription polymerase chain reaction (RT-PCR) testing for COVID-19 have not been clearly reported. RT-PCR testing is most useful when tests are positive, but it's less useful for ruling out infection with SARS-CoV-2, the virus that causes COVID-19. Therefore, a negative RT-PCR test does not mean a person is free of the disease, noted Dr. Priya Sampathkumar of the Mayo Clinic in Rochester, MN, in a release.April 12, 2020Health TopicsTesting delays hamper hospitals in COVID-19 responseHospitals say that delays of up to a week in getting COVID-19 diagnostic test results are creating a crunch in intensive care units (ICUs) as patients must remain hospitalized until their results come back. And supplies for COVID-19 diagnostic kits are in such short supply that some facilities are dividing media in half to double their testing capacity.April 9, 2020Health TopicsDid BodySphere jump the gun on '2-minute' COVID-19 test?And in the end, it apparently was false. News reports have questioned the company's claims, and BodySphere's chairman and CEO has walked back the company's assertion that it had received the FDA's imprimatur. But the firm said it still intends to sell the test on the market.April 2, 2020Moderate Complexity TestFDA gives states, vendors more power in coronavirus fightThe FDA has been under heavy pressure to ease its regulations on diagnostics to get more tests into the field for the SARS-CoV-2 coronavirus, which causes the COVID-19 respiratory disease. Clinicians and public health authorities have claimed that not enough tests are available to meet demand, so the agency has made a series of regulatory changes over the last several weeks that relax its oversight.March 15, 2020PCRFDA grants EUA to Thermo's coronavirus diagnostic testThe FDA granted the EUA to Thermo Fisher's TaqPath COVID-19 combo kit, a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test that can diagnose the SARS-CoV-2 virus, which causes COVID-19.March 15, 2020InfectiousTEST -- ignoreMarch 14, 2020Moderate Complexity TestTrump emergency plan boosts diagnostic testing rolloutIn an address at the White House Rose Garden, Trump announced a series of sweeping measures designed to eliminate government regulations that may have been hindering the federal response to the coronavirus outbreak. Most of Trump's address was devoted to the administration's plans for making diagnostic testing more available across the country -- an issue that has become a flash point for criticism of the administration's response to the virus.March 12, 2020Previous PagePage 3 of 6Next PageTop StoriesHIVHIV vaccine trial begins enrollment in U.S., South AfricaA clinical trial for a preventive HIV vaccine has begun enrollment in both the U.S. and South Africa.Alzheimer'sAlzheimer’s drug approval poised to reshape APOE testing marketStockInvitae receives noncompliance notice from NYSEArtificial IntelligenceAI model reveals kidney tumor features, potential for treatment response predictionSponsor ContentAt-home or Lab-based STI testing/collection