DeZwarteRidder schreef op 17 maart 2020 17:06:
Updated FDA Policy Likely Enables Near-Term Availability of COVID-19 Test in the U.S.
ENGLEWOOD, CO / ACCESSWIRE / March 17, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that the company intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of yesterday's updated FDA policy on coronavirus diagnostic testing.
On March 16, 2020 the FDA announced, "as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests..." Further, the agency made recommendations specifically for test developers stating that "the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated" and other labeling conditions are satisfied.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "While we are still working with FDA on making the COVID-19 Rapid Test available, we believe that this updated policy may enable near-term availability of our recently-licensed point-of-care test. During this public health emergency, we are working tirelessly to satisfy all requirements in order to make the test available to the professional medical community as soon as possible." Disbrow also commented that, "We have already gotten confirmation from the manufacturer that our initial supply is being shipped and is expected to arrive in the U.S. very soon."
The company will continue to provide updates about the near-term availability of the COVID-19 test.