Chembio Diagnostics gets European approval to sell new test
Medford-based Chembio Diagnostics. Credit: Heather Walsh
Chembio Diagnostics Inc. announced Monday that a new rapid blood test, developed with pharmaceutical giant AstraZeneca, has been certified as meeting European health and safety standards.
The test, which detects a biomarker, or substance that shows a disease or infection in the body, has received the CE mark, which is necessary to sell products in European Union member countries.
Chembio and AstraZeneca haven't disclosed what the biomarker is.
The CE designation, an abbreviation of Conformité Européenne, comes a year after Chembio, a small public company in Medford, began receiving funds from AstraZeneca to develop the point-of-care test. AstraZeneca, with headquarters in Cambridge, England, was to pay Chembio up to $2.9 million for the test.
AstraZeneca sells the acid reflux medicine Nexium and other drugs.
“We are pleased to receive the CE mark within 12 months of announcing the collaboration with AstraZeneca,” Chembio CEO John J. Sperzel said Monday. “We look forward to working closely with AstraZeneca in pursuit of additional regulatory approvals.”
Chembio develops and manufactures rapid tests for HIV, syphilis, malaria and other tropical diseases. The tests have been used by the World Health Organization and others to combat recent outbreaks of Ebola and Zika.
The company reported a loss of $4.7 million for the nine months ended Sept. 30, 2018, compared with a loss of $4.4 million for the same period in 2017. Revenues totaled $25.8 million in the nine-month period, up from $18 million in 2017.
Chembio recently won $815,400 in tax breaks over 10 years from the Suffolk County Industrial Development Agency to consolidate the company's Medford and Holbrook operations into a single building in Hauppauge. Executives said the $3.9 million project will automate much of the production activity.
IDA records show that Chembio now employs 223 people in Suffolk and expects to have 201 in three years. The company also has a factory in Malaysia and offices in Germany.
Chembio shares rose more than 8 percent Monday to close at $6.49 on the Nasdaq Stock Market.
James T. Madore writes about Long Island business news including the economy, development, and the relationship between government and business. He previously served as Albany bureau chief.
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