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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.

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Oct
09
Sponsored by
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.