The FDA is taking aim at entities marketing Zika tests without approval, firing off letters to three companies so far this month.
In “it has come to our attention” letters, the FDA calls out MD Biosciences for marketing its Zika Virus RNA by RT-PCR Assay as well as Texas Children’s Hospital and Houston Methodist Hospital for marketing their Zika Direct Test.
MD Biosciences made its test available on Feb. 29, saying the assay can be performed in a few hours. However, MD Biosciences later announced that testing services will not be offered, pending clarification with the FDA regarding “any pre-market approval requirements pertaining to this assay.”
Eddie Moradian, CEO of MD Biosciences, says the company has no comment, “except that we welcome the discussion and will be fully cooperating with the FDA regarding our laboratory developed test.”
Texas Children’s and Houston Methodist announced Feb. 23 the release of “the country’s first hospital-based rapid tests for the Zika virus.” They say the tests were developed by pathologists and clinical laboratory scientists “in a matter of weeks.”
The pair are working collaboratively with the FDA and sharing information regarding the tests’ design, validation and performance characteristics, says spokeswoman Christy Brunton.
“The FDA has not asked us to discontinue use of our tests. Currently, our rapid Zika tests are only offered to our registered patients,” she tells IDDM.
In a third letter, the FDA names First Diagnostic for marketing its ATFirst’s One Step Zika Antibody Test, which is intended for simultaneous detection and differentiation of IgG and IgM antibodies to Zika virus in human serum, plasma or whole blood.
However, Jonathan Adam Barash, president of First Diagnostic, says its test is in the development phase and not being marketed.
“We were shocked to receive the letter, actually,” Barash tells IDDM. He says he subsequently participated in a conference call with FDA officials, who later acknowledged that the agency mistakenly thought the company was marketing the test. However, the FDA would not confirm Barash’s statement.
Tara Goodin, FDA spokeswoman, says the agency encourages laboratories to develop Zika tests, but the tests should not be used for clinical diagnoses without approval, clearance or authorization.
“Because of the serious public health impact of the Zika virus in certain populations, the FDA is requesting that those with tests for the detection of Zika virus in patient samples submit a request for emergency use authorization to the agency,” she tells IDDM.