Fox Rothschild Secures FDA Permission for 15-Minute Coronavirus Screening TestMarch 27, 2020 – Press Releases
A team of health law attorneys in Fox Rothschild LLP’s New York office have secured FDA authorization to distribute a coronavirus screening test that delivers results within just 15 minutes from a pinprick with no instrumentation required.
Margaret J. Davino utilized a newly updated FDA policy designed to accelerate testing for the novel coronavirus. They represent Ideal Rehab Care Inc., an authorized distributor for the COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device manufactured by Healgen Scientific LLC, a China-based medical device manufacturer.
The FDA decision on March 26 authorized more than two dozen serology tests to screen for coronavirus.
According to FAQs on the agency’s website, pursuant to the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA “does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated.”
“We’re thrilled that the FDA was able to act so quickly, not only to revise its policy on March 16, but to implement that policy and grant authorizations just 10 days later,” Davino said. “This is a tremendous example of government, scientists and industry working with a unified purpose in the face of an unprecedented emergency to solve one of the most pressing issues in this crisis.”
Joseph W. Rohe, a member of Fox Rothschild’s International Trade practice, is representing Ideal Rehab Care to clear the way for importing the tests from Singapore as soon as possible.
Rohe, who is resident in Fox Rothschild’s Greenville, SC, office, said he anticipates a similarly cooperative approach to the legal work on importing the tests. “We’re very encouraged that the FDA has strongly signaled its willingness to help in the import process. Every day we can shave off in getting these tests in the hands of doctors will mean lives saved.”
Shahnam Sharareh, PharmD, RAC, assisted the team with validation and requirements for validation.