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

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.

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.

The development and authorization of COVID-19 POC and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that lessons learned from our experiences with COVID-19 could be leveraged to facilitate a large-scale effort for swift, widespread access to accurate and reliable tests for a variety of diseases. Source: Health Affairs.

“The Biden administration is preparing to launch the first of several Covid-19 testing hubs to coordinate and oversee a $650 million expansion of testing in K-8 schools and congregate settings like homeless shelters.” HHS expects “to open the first hub in April, as part of a public-private partnership that could eventually add up to 25 million tests per month to the nation’s testing totals, two sources briefed on the plans told POLITICO.” This initiative “is the first attempt at formalizing a national testing strategy – something public-health experts have wanted for months.” It follows a marked decline in US COVID-19 testing from about 2 million per day in January to 1.5 million currently. The article mentions “Bruce Tromberg, a scientist at the National Institutes of Health who leads the federal government’s Rapid Acceleration of Diagnostics initiative.” Source: Politico

At the Feb 24, 2021, U.S. Congressional Optics & Photonics (O&P) Caucus launch event, NIBIB Director Bruce Tromberg spoke about the impact that optics and photonics technologies have had in advancing cutting-edge methods, discoveries and devices in biology and medicine. Source: Optics & Photonics.