FDA Commissioner Stephen Hahn apologized last week for overstating the benefits of convalescent plasma therapy for COVID-19 patients. The bone of contention stems from Hahn saying that preliminary findings from a Mayo Clinic studyshowed there was ‘absolute’ instead of ‘relative’ risk reduction of COVID-19 in patients who were treated with convalescent plasma. The theory behind convalescent plasma is that people who have been afflicted with COVID-19 that have recovered will have antibodies in the blood that helped fight off the infection. The thought is that if people who are sick with the virus are given this plasma they could recover. FDA gave emergency use authorization to the therapy last weekend. The EUA was based on clinical results from the Mayo Clinic study. In an interview with CBS This Morning, Hahn warded off criticisms that FDA was pressured to grant the therapy EUA. “I could have done a better job, and should have done a better job, at that press conference explaining what the data show regarding convalescent plasma," he said. "I can assure the American people that this decision was made based upon sound science and data.”
Foundation Medicine added another chapter to the liquid biopsy story after it won approval for a Pan-Tumor test with multiple companion diagnostic indications. The Cambridge, MA-based company made the Foundation Liquid CDx available on Friday and said the diagnostic is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries. FDA approval was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.
FDA issued an emergency use authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card for rapid detection of COVID-19 infection. Described as being about the size of a credit card, the test is priced at $5 and can generate results in 15 minutes, according to Abbott. The BinaxNOW COVID-19 Ag Card uses Abbott’s lateral flow technology, and testing professionals do not need special equipment for sample processing. The EUA authorizes the test to be used by healthcare professionals in point-of-care settings. The test can also be used by professionals in near-patient settings.