LONDON (Alliance News) - Akers Biosciences Inc on Wednesday said its flagship rapid tests for allergic reactions to the widely used blood-thinner Heparin has been approved for use across China.
Herapin is an anticoagulant, or blood thinner, that prevents the formation of blood clots and Akers' PIFA Heparin/PF4 Rapid Assay and other associated assays have been approved for use across mainland China by the China Food and Drug Administration.
Akers said these are the first and only tests for PF4 antibodies, which is associated with the condition known as Heparin-Induced Thrombocytopenia, to be approved in China.
NovoTek, a Beijing-based pharmaceutical and medical device business development company, holds the exclusive sales and marketing rights for the Akers' PIFA Heparin/PF4 devices in China.
"NovoTek had already begun pilot sales of the tests under a temporary emergency waiver granted by the China Food and Drug Administraion. 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 Heparin-Induced Thrombocytopenia," said Akers.
Akers said its PIFA Herapin/PF4 devices are still the only US Food and Drug Administration-cleared rapid manual assays that quickly determine if a patient being treated with the blood thinner heparin may be developing Heparin-Induced Thrombocytopenia, or HIT.
"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 Akers, 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," he added.
Akers shares were down 2.8% to 175.0 pence per share on Wednesday.
By Joshua Warner; joshuawarner@alliancenews.com; @JoshAlliance
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