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FDA approves LI firm's 15-minute diagnostic test for coronavirus

Chembio research and development director Dhammika Gunasekera, right,

Chembio research and development director Dhammika Gunasekera, right, and scientist Kathleen Simonetti perform a coronavirus test in the company's Long Island laboratory.  Credit: Courtesy of Chembio Diagnostics Inc.

A Hauppauge company's rapid diagnostic test for the coronavirus has been approved by the FDA for use in the United States, officials said.

Chembio Diagnostics Inc. announced it will begin shipping the blood test this month after winning “emergency use authorization” from the federal Food and Drug Administration. Test results are produced in 15 minutes.

The Chembio test joins others already in use on Long Island and elsewhere.

A rapid test from Abbott Laboratories in Illinois has been available at three urgent care centers in Nassau and Suffolk counties, starting this week. Medical products distributor Henry Schein Inc., the Island's largest public company by revenue, is selling rapid tests from BioMedomics Inc. in North Carolina and SD BioSensor Inc. in South Korea.

Demand for the 15-minute tests has soared with the number of coronavirus cases and deaths. Patients flocked to the AFC Urgent Care locations in Farmingdale, West Islip and East Meadow on Wednesday for the Abbott test.

The rapid tests may ease the shortages on Long Island where too few tests and processing delays have left patients in limbo.

The Chembio point-of-care test was developed with British test maker LumiraDX in about a week. The local company announced March 20 it had won a $4 million purchase order from the Brazilian government.

The blood test “can help improve clinical outcomes through the management of individual patients by enabling clinicians to understand the likelihood of past and present infection and to manage populations as a whole,” said Richard Eberly, who took the reins at Chembio as CEO last month.

He said the rapid test helps physicians determine a patient’s current or past exposure to the coronavirus by detecting the presence of antibodies in the blood that are produced by the body in response to the virus. The number of IgM and IgG antibodies signals whether the patient may still be infectious and could possibly transmit the virus to others, he said.

Last month, President Donald Trump vowed to speed up the FDA’s approval of tests and vaccines for the coronavirus. He and Gov. Andrew M. Cuomo have said increased testing is critical to slowing the virus’ spread.

In Brazil, the Chembio test will be used in the public health system under an emergency use authorization from the Ministry of Health.

The quick development of a coronavirus test highlights “Chembio’s ability to respond in an expeditious manner to global pandemics with differentiated solutions, as demonstrated previously with Zika and Ebola,” said Gail S. Page, a company director and former interim CEO.

Chembio is moving to a new headquarters, factory and warehouse at 555 Wireless Blvd., where about 250 people will work. The new facility will replace operations in Medford and Holbrook. The company also has small facilities in Malaysia, Germany and Brazil.

Page said Thursday the coronavirus test will come from its Hauppauge and Medford factories while the results reader will come from the company's unit in Germany. "We will be ramping up in the month of April and continuing to manufacture in line with the demands of the market," she said.

Chembio, with its shares traded on the Nasdaq stock market, reported a loss of $13.7 million last year on revenue of $34.5 million.

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