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Akers Biosciences pulls out US FDA application for chlamydia blood test device

Akers Biosciences Inc. withdrew its initial 510(k) application to the U.S. Food and Drug Administration for the company's chlamydia rapid blood test device.

Following a recommendation by the U.S. drug regulator, Akers Biosciences is withdrawing the PIFA chlamydia rapid assay to re-evaluate its options in developing the product.

The PIFA chlamydia rapid assay is a diagnostic test device for chlamydia, a common sexually transmitted infection.

"The setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the company," said John Gormally, CEO of the Thorofare, N.J.-based healthcare equipment company.