The Blood Profiling Atlas in Cancer Consortium (BloodPAC) said it has published a series of generic protocols directed toward analytical validation of next-generation sequencing (NGS) assays for circulating tumor cells, a document intended to serve as a series of standards for development of liquid biopsies. BloodPAC said the FDA has asked the group to commence with a second phase of this effort for assays that detect and monitor disease progression after initial treatments to address any residual disease as well. Jim Godsey, vice president for assay development at San Diego-based Illumina Inc., and co-chair of the analytical variables working group at BloodPAC, said the validation protocols “establish a vital piece of infrastructure that will accelerate the development of new tools to improve cancer care.” Godsey added that the protocols are the end result of collaboration between test developers, academic researchers and the FDA. The guidelines appear in the Sept. 1 issue of Clinical Chemistry.
The U.S. FDA said it will convene a Nov. 9, 2020, hearing of the ophthalmic devices advisory committee to make recommendations for the PMA filing for the Visability micro insert device by Refocus Group Inc., of Dallas. The hearing was initially scheduled for June 9, but was scotched due to the COVID-19 pandemic. The FDA said it will handle the hearing via an “online teleconferencing platform.” The device is preliminarily indicated for bilateral scleral implant for improvement of near vision in phakic, presbyopic patients aged 45-60 years. The agency will post meeting materials no later than two days prior to the date of the hearing.
The U.S. Department of Health and Human Services has teamed up with the Federal Communications Commission (FCC) and the Department of Agriculture to foster rural telehealth development via a memorandum of understanding (MOU) that will expand telemedicine in underserved areas. The HHS statement indicated that the MOU expands on previous efforts by the FCC to permanently expand the infrastructure for access to telehealth services, although the newly christened Rural Telehealth Initiative (RTI) calls for development of an interagency task force that will consider the resources of all three agencies to expand telehealth infrastructure, including access to broadband.
Although the FDA last week granted emergency use authorization (EUA) for convalescent plasma to treat patients hospitalized with COVID-19, the NIH’s COVID-19 Treatment Guidelines Panel said Sept. 1 there is insufficient data to recommend either for or against its use. In updated treatment guidelines, the panel stressed the need for prospective, well-controlled, adequately powered randomized trials to determine whether convalescent plasma is effective and safe. The panel added that convalescent plasma should not be considered standard of care for treating patients with COVID-19. The update echoed what FDA Commissioner Stephen Hahn said when he announced the EUA. He noted the need for “adequate and well-controlled randomized trials” to definitively demonstrate the efficacy of convalescent plasma and to determine its optimal attributes and the appropriate patient populations. The EUA was not intended to make convalescent plasma the new standard of care for treating patients with COVID-19, Hahn said.