Avellino Lab USA Inc. has developed a diagnostic test for the novel coronavirus SARS-CoV-2, which has been validated in keeping with the U.S. Food and Drug Administration (FDA)'s Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Physicians can order the assay now, while the company continues testing.

Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.

LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.

The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act.

AI-based, digital pathology startup Proscia Inc. has partnered with the University of California at San Francisco (UCSF) to advance the practice of pathology via artificial intelligence (AI). The pair will start with prostate cancer and then plan to move on to validate approaches in several additional pathology subspecialties.

BEIJING – More and more companies and researchers in China are rolling out artificial intelligence (AI)-based systems that can process hundreds of computed tomography (CT) images in seconds to speed up diagnosis of COVID-19 and assist in its containment.

Thermo Fisher Scientific Inc., of Waltham, Mass., has made a bold play in the molecular diagnostics market, including infectious disease testing, with its proposed $11.5 billion acquisition of Qiagen NV, of Venlo, Netherlands. Word of the deal comes after reports late last year that named Thermo Fisher as a potential suitor for Qiagen. However, in late December, Qiagen said it had wrapped up a review of potential strategic alternatives and decided its standalone business plan represented the best opportunity for value creation.

With trauma patients and those suffering from bleeding disorders, being able to quickly assess a person’s bleeding risk can be lifesaving, but most current tests to measure clotting ability are laboratory-based and don’t provide immediate results. To that end, the U.S. FDA has granted Cleveland-based Xatek Inc. breakthrough device designation for its Clotchip portable blood clotting sensor.

New York and Rehovot, Israel-based in vitro diagnostics startup Todos Medical Ltd. is developing blood tests for the early detection of cancer and neurodegenerative diseases using Fourier-transform infrared (FTIR) spectroscopy. Now the company is looking to apply the technology in diagnosing infections, including the novel coronavirus, COVID-19.

LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.