A medical products manufacturer in Hauppauge has developed a new diagnostic test for the coronavirus and received a $4 million purchase order from Brazil, officials said Friday.
Chembio Diagnostics Inc. completed work on the rapid point-of-care test in about a week, in partnership with another test maker, LumiraDX in London.
The businesses announced on March 12 that they would create a coronavirus test for their respective testing platforms. A blood test using Chembio’s DDP platform has been developed but awaits the approval of regulators in Brazil and the United States, executives said Friday.
They said Chembio will begin a pilot study at U.S. research centers to provide the results necessary to win “emergency use authorization” from the U.S. Food and Drug Administration. None of the research centers are on Long Island, according to a spokesman.
President Donald Trump has pledged to speed up the FDA’s approval of tests and vaccines for the coronavirus. Trump and Gov. Andrew M. Cuomo have said increased use of diagnostic tests is critical to slowing the virus' spread.
Javan Esfandiari, Chembio’s chief science and technology officer, said Friday its testing platform “enabled our team to develop a high-quality test” for the coronavirus “efficiently and rapidly.” The test “will detect the presence of antibodies in blood indicating that a person had an immune response [to the coronavirus], regardless of whether symptoms developed from infection or if the infection was asymptomatic,” he said.
Brazil’s Bio-Manguinhos, which provide tests, vaccines and medicine to the Ministry of Health, will purchase the Chembio coronavirus test upon its approval by Brazilian regulators under an emergency use authorization program. The order is valued at $4 million.
Esfandiari said Chembio has previously supplied tests for HIV, syphilis, Zika and other viruses for use in Brazil’s public health system. Last year, the company purchased a testing business in Rio de Janeiro for $150,000 in cash and more than $3 million in Chembio shares.
Chembio shares closed up 7 cents, or 24%, to $3.63 on the Nasdaq stock market on Friday.