Akers Biosciences, Inc., (ABI), a designer and manufacturer of rapid diagnostic screening and testing products, has announced a distribution agreement for its PIFA Heparin/PF4 and PIFA PLUSS PF4 rapid tests with Medline Industries, Inc. Under the terms of the agreement, Medline, which has a network of 40 distribution centers in the United States and 1,200 dedicated sales representatives worldwide, is expected to begin marketing the company's tests to a large network of hospitals and surgery centers across the United States.
PIFA Heparin/PF4 and PIFA PLUSS PF4 are FDA-cleared, single-use tests which quickly determine if a patient being treated with the blood thinner heparin may be developing a drug allergy. The resulting clinical syndrome, referred to as heparin-induced thrombocytopenia (HIT), reverses heparin's intended effect of thinning the blood and transforms it into a clotting agent, which can result in death or limb amputation.
In the United States, approximately 12 million patients are exposed to heparin annually, and 1% to 5% are diagnosed with HIT. The largest number of at-risk patients is those undergoing major cardiac or orthopedic surgery. It is estimated that up to half of cardiac surgery patients develop HIT-antibodies.
Company representatives stress that ABI's PIFA Heparin/PF4 Rapid Assay delivers a result in less than 10 minutes after the blood sample has been prepared. They also assert that the PIFA PLUSS PF4 extension of the test further improves the rate at which hospitals can obtain a HIT-antibody result as it now incorporates ABI’s patented Rapid Blood Cell Separation Technology. This technology eliminates the need for blood sample preparation, meaning the test can be carried out in minutes at the point of care. Learn more about the PIFA PLUSS PF4 rapid test.
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