Akers Biosciences (NASDAQ:AKER LON:AKER) has started to supply its test for Heparin allergy or HIT into China after it was cleared for medical use in the country.
NovoTek Therapeutics, its Chinese distributor, has placed a US$2.5mln order that will be fulfilled in tranches throughout 2016.
Beijing-based Novotek has exclusive sales and marketing rights for PIFA Heparin/PF4 Rapid Assay products in China.
Initial sales are anticipated prior to the end of the first quarter.
HIT is a potentially fatal allergy to Heparin, a widely used blood thinning drug. The allergy reverses the effect of Heparin and turns it into a clotting agent, which is especially dangerous for patients undergoing major cardiac, orthopaedic or other surgical procedures.
Between 1% and 5% of those patients using Heparin receive a HIT diagnosis.
The PIFA Heparin/PF4 Rapid Assay and PIFA PLUSS PF4 version (which tests whole blood) are the first and only tests of any kind for PF4 antibodies (associated heparin-induced thrombocytopenia (HIT)) available in China, Akers said.
The rapid assay test is also the only one so far approved in the US, where the company hopes to have 500 hospitals prescribing it by the end of 2016.
Raymond Akers Jr, executive chairman, added: "The China FDA's approval of our test paves the way for Akers Bio and NovoTek to establish the PIFA Heparin/PF4 Rapid Assay devices as the gold standard for HIT testing throughout China."
He added that NovoTek will now set up a complete solution to manage HIT in the Chinese healthcare system through exclusive licences both for the test and as a treatment for patients diagnosed with HIT.
Broker finncap said that against a sales base of US$4mln, Novotek's represents a substantial order.
There are estimated to be 12mln patients who are prescribed Heparin in China and with 1-5% of patients developing HIT, the potential demand is for up to 0.6mln tests per annum, it adds.