The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
Astrotech Corp., of Austin, Texas, has a broad range, having developed mass spectrometers in agriculture and manufacturing and selling chemical analyzers for use in the airport security and other applications. Now, it is looking to help in the fight against COVID-19.
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
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