Akers Biosciences has decided to withdaw its initial 510(k) application for PIFA Chlamydia in order to re-evaluate its options with regards to this product development opportunity, upon a recommendation from the US Food and Drug Administration (FDA).
John J. Gormally, Chief Executive Officer of Akers Bio, said: “The setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the Company, and the board believes this course of action will allow the board and management to better evaluate all options.
He said that at the same time, the company will stay focused on driving sales growth of its currently commercialized products and, in particular, PIFA Heparin/PF4 Rapid Assay, through expanded distribution and a strategic focus on clinical end-users and integrated delivery network customers.