The FDA’s approval last month of “two rapid at-home antigen tests, Abbott’s BinaxNOW and Quidel’s QuickVue, [which] will soon be sold over the counter on drugstore shelves, without the need for a prescription.” The article says these approvals have critical potential impact on the testing front and will help the US catch up to other developed nations in terms of rapid antigen testing. The piece highlights comments in an interview by Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering, who said, “We are in a risky period with variant growth, incomplete vaccination, return to school, increased population mobility and reduced mask wearing. ... The need to do screening, using accessible tests at home, on a large scale and on a regular cadence, is even more important.” Source: Scientific American

Greenlight Guru, the medtech industry's leading medical device quality management software (MDQMS) platform, today announced its selection as the premier QMS for the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program, led by the National Institute of Biomedical Imaging and Bioengineering. This program aims to improve the speed of innovation in the development, commercialization and implementation of technologies for COVID-19 testing. Source: Prnewswire

NIBIB-funded engineers have developed a flexible epidermal patch that can simultaneously and continuously monitor cardiac output and metabolic levels of glucose, lactate, caffeine, or alcohol. The patch is a major step towards continuous non-invasive health monitoring.

he US RADx program has spawned a phalanx of diagnostic products to market in just 12 months. Its long-term impact on point-of-care, at-home and population testing may be even more profound. Source: Nature Biotechnology

The Centers for Disease Control and Prevention and the National Institutes of Health announced a new initiative on Wednesday to help determine whether frequent, widespread use of rapid coronavirus test slows the spread of the virus. Source: The News Times.

Two US counties will receive a surge of free, rapid, at-home Covid-19 tests in an effort to study how people use them and how that impacts Covid-19 trends in the community, according to an announcement Wednesday by the National Institutes of Health. Source: CNN.

The CDC, in collaboration with the NIH, has launched an innovative community health initiative called “Say Yes! COVID Test.” Up to 160,000 residents in two US communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month.

NIH has awarded four additional contracts for the development and scaled-up manufacturing of new COVID-19 diagnostic testing technologies through its Rapid Acceleration of Diagnostics Tech (RADx) initiative. The awards total $29.3 million and will help increase testing capacity for COVID-19.

ROSALIND, a software leader in extracting meaningful insights from diverse pools of life science data, today announced the launch of a web-based platform for monitoring the emergence of SARS-CoV-2 variants and evaluating the effects on the performance of diagnostic tests. The new platform, called the ROSALIND Diagnostic Monitoring (DxM) system, is available starting today and will be used by diagnostic test manufacturers and regulators to monitor assay performance against the rapidly evolving SARS-CoV-2 variants. Source: Business Wire.