Aggredyne Secures FDA Approval for AggreGuide A-100 ADP Assay to Evaluate Antiplatelet Drug Response

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on April 8, local time in the United States, Aggredyne, headquartered in Houston, Texas, announced that its AggreGuide A-100 ADP Assay Kit had received approval from the U.S. FDA. This kit is an in vitro diagnostic device used to measure the efficacy of various antiplatelet drugs targeting the platelet P2Y12 receptor.

It is reported that the FDA has authorized Aggredyne to market the AggreGuide A-100 ADP Assay Kit in the United States and has approved the company’s further expansion of the menu of additional tests compatible with the A-100 instrument. Both the A-100 instrument and its companion A-100 AA Assay Kit received FDA approval in 2013 for determining the effect of aspirin on platelet activity.

Aggredyne is a rapidly growing medical device company co-founded in 2011 by accountant Robert C. Hux and Edward R. Teitel, M.D., with the aim of developing state-of-the-art medical diagnostic tools to help physicians improve patients’ healthcare experience.

Aggredyne’s core technology is the AggreGuide system, a platelet function analyzer that measures platelet adhesiveness and assesses patient response to antiplatelet medications such as aspirin, Plavix, Effient, and Brilinta. Patient responses to antiplatelet therapy vary, and these variations may be associated with the risk of ischemic events. By utilizing the AggreGuide system to evaluate patients’ platelet function, Aggredyne enables the delivery of the safest and most reliable treatment strategies.

AggreGuide technology was originally co-developed by scientists at Brigham Young University and the University of Utah, and has since been commercialized by Aggredyne.

Many individuals experience side effects such as platelet dysfunction after taking antiplatelet drugs; in severe cases, this may lead to heart attack or stroke due to circulatory obstruction. Variability in individual responses to antiplatelet therapy means that some patients who suffer from adverse effects do not receive adequate protection.

AggreGuide A-100 ADP Detection Kit (Image from the official website)

The AggreGuide A-100 ADP Assay Kit is essentially a convenient platelet analyzer. This kit employs a unique ADP filter cartridge to simulate blood flow within the human body, thereby measuring patient platelet function based on platelet aggregation tendency. Furthermore, the accompanying A-100 instrument utilizes laser scattering to rapidly quantify platelet aggregates in samples, with some tests requiring only a few drops of whole blood.

It is worth noting that the A-100 analyzer operates in a nearly fully automated manner, requiring minimal manual intervention. This testing instrument eliminates the need for blood centrifugation and does not require any reagent mixing. Users can obtain platelet test results within five minutes after whole blood sample collection.

“This approval marks a significant milestone in Aggredyne’s development, enabling us to provide hospitals, diagnostic laboratories, and other institutions with a comprehensive suite of innovative platelet testing technologies,” said Robert C. Hux, CEO of Aggredyne. “The AggreGuide A-100 ADP Assay Kit is the first FDA-cleared assay for measuring the effects of the novel antiplatelet inhibitors Brilinta and Effient. We are actively pursuing regulatory classification for the kit to support the direct placement of our platelet testing devices in physicians’ offices.”

(Compiled by Wang Chan)