Akers Biosciences, Inc., a medical device company, announced that the China Food and Drug Administration (CFDA) has approved for medical use throughout Mainland China the company's flagship rapid tests for allergic reactions associated with the widely used blood-thinner, heparin.
The company's PIFA Heparin/PF4 rapid assay and PIFA PLUSS PF4 version which tests whole blood are the first and only tests for PF4 antibodies associated with the condition known as heparin-induced thrombocytopenia (HIT) to be approved in China.
NovoTek, a Beijing-based pharmaceutical and medical device business development company, holds the exclusive sales and marketing rights for Akers' PIFA Heparin/PF4 devices in China. NovoTek had already begun pilot sales of the tests under a temporary emergency waiver granted by the CFDA. It now expects to roll out its marketing of the tests to hospitals throughout China where NovoTek has also obtained an exclusive license for a direct thrombin inhibitor used for treating patients diagnosed with HIT.
Akers' PIFA Heparin/PF4 devices are becoming more widely used in the US, where they remain the only US FDA-cleared rapid manual assays that quickly determine if a patient being treated with the blood thinner heparin may be developing HIT. Patients suffering HIT are at risk of developing limb- and life-threatening complications, so the timely test result provided by the company's Heparin/PF4 devices is paramount to effective, clinical decision making.
"Unlike in the US, where Akers Bio's tests are gradually replacing a pre-existing, slow and costly laboratory testing process for HIT, China, as far as we know, has no established testing procedure whatsoever for the condition," said Raymond F. Akers, Jr. PhD, co-founder and executive chairman.
"We believe NovoTek's total solution for diagnosing HIT using our tests, and providing an antidote where HIT is diagnosed, has the capacity to dramatically reduce the serious complications which can arise from the use of heparin," continued Dr. Akers.
"In the US, where some 12 million people are exposed to heparin annually, 1 to 5 percent of those patients receive a HIT diagnosis," said Dr. Akers.
"In China nearly all anticoagulation is performed using heparin. China's healthcare system is rapidly westernizing and we believe the need for reliable and timely diagnosis of HIT is becoming increasingly recognized there."
"We believe China could ultimately become one of Akers' biggest markets for the PIFA Heparin/PF4 devices," added Dr. Akers.