NEW YORK (360Dx) – Aggredyne said today that the US Food and Drug Administration has granted clearance for its AggreGuide A-100 ADP Assay, a cartridge used to measure the effect of antiplatelet medications that target P2Y12, a platelet receptor.
The clearance allows the company to market the assay throughout the US and further expands the menu of tests that can be used with the firm's A-100 instrument, Aggredyne said. In 2013, the FDA cleared the A-100 instrument and a companion A-100 AA assay cartridge used to determine the effect of aspirin on platelet activity.
Houston-based Aggredyne said that the A-100 ADP cartridge was evaluated for clearance at several US clinical sites using FDA-approved combinations of dual anti-platelet therapies, including medications such as clopidogrel bisulfate (Plavix), ticagrelor (Brilinta), and prasugrel (Effient).
The ADP cartridge simulates whole-blood flow in motion within a microfluidic reaction chamber, similar to the flow of blood within the human body, Aggredyne said. The companion A-100 instrument uses laser light scattering to quickly quantify platelet aggregates in the sample. A single test requires a few drops of whole blood.
With the clearance, the firm offers a full portfolio of "platelet testing technologies for hospitals, diagnostic labs, or any duly-certified entity in the US," Aggredyne CEO and President Robert Hux said in a statement. "We are now working toward obtaining the necessary regulatory classification to allow placement of our platelet testing devices directly in physician offices," he said.