First-of-its-kind sexual infections test from Hologic approved by FDA
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Hologic's Marlborough headquarters
The U.S. Food and Drug Administration has approved the first two tests to detect certain sexually transmitted infections outside of the genitals, and one of those tests belongs to Marlborough medical device maker Hologic.
The Aptima Combo 2 Assay can detect chlamydia and gonorrhea via samples from the throat and rectum. Previously, tests were only cleared for testing samples from urine or the genitals.
In a statement, the FDA said the tests, including one belonging to California-based Cepheid, fill an unmet public need.
“It is best for patients if both of these sexually transmitted infections are caught and treated right away, as significant complications can occur if left untreated,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s clearances provide a mechanism for more easily diagnosing these infections.”
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