The U.S. National Institutes of Health (NIH) said it has developed a novel method of sample preparation for tests for the SARS-CoV-2 virus, which could trim time and costs for diagnostic testing for COVID-19. This approach bypasses the RNA extraction step, thus eliminating the need for some supplies, and NIH said this technique is available for co-development or licensing with the private sector, giving the smart testing company access to a patent-protected technology with an existing demand already built in.
The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.
Neuropace Inc. nabbed $9 million in the form of a five-year NIH grant as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The grant will support the study of the Mountain View, Calif.-based company’s Responsive Neurostimulation (RNS) system in patients with Lennox-Gastuat syndrome (LGS), a debilitating form of epilepsy.
The World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria signed a cooperation and financing agreement to implement 10 initiatives in 2021 through 2023 aimed at addressing persistent challenges impeding global progress against the three diseases and protecting hard-won gains from new pandemics like COVID-19.
The Biden administration released its full budget proposal for fiscal year 2022, increasing the FDA’s budget authority to nearly $3.6 billion, up 10% over 2021. The Alliance for a Stronger FDA said that though analysis is needed to parse out the details, the proposal will be supported.
The May 25 appearance of Francis Collins, director of the U.S. National Institutes of Health, before a congressional committee revolved in large part around the Biden administration’s so-called ARPA-H proposal, but the administration’s proposal to waive intellectual property rights for vaccines was also on tap.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of infusion sets; Recall announced for Roche testing systems; NIH announces technique for improved photoreceptor imaging.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM.