Hauppauge-based Chembio Develops Rapid COVID-19 Test

Chembio picture (1)

Shares of a  Long Island-based company shot up after it said it developed a rapid diagnostic test designed to detect COVID-19, received a $4 million order for distribution in Brazil, and is gearing up to test it in the United States.

Hauppauge-based Chembio Diagnostics, which focuses on developing tests for infectious diseases, on March 20 said it obtained the order from Bio-Manguinhos for its DPP COVID-19 IgM/IgG System.

The company’s stock shot up about 24 percent or 70 cents to as high as $4.65 on March 20 before closing for the day at $3.63, as about 2.2 million shares traded, roughly 10 times the average.

The announcement provided an injection of potentially good news for Chembio, as well as those who could benefit from the test, pushing the stock up, while ending the day toward the lower end of its 52-week range from $2.25 to $7.90.

Sunnyvale, Calif.-based Cepheid, meanwhile, on March 21 said it had obtained emergency use authorization from the U.S. Food and Drug Administration for its rapid test to detect the virus causing COVID-19. 

The Cepheid test was designed to operate on Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, including 5,000 in the United States, taking 45 minutes to produce a result.

“We have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly,”  Dr. David Persing, Cepheid chief medical and technology officer, said.

Cepheid President Warren Kocmond said these “automated systems do not require users to have specialty training to perform testing” and can run around the clock with tests set to begin shipping next week.

Chembio’s product, on the other hand, is a single-use, rapid point-of-care test that detects certain antibodies to COVID-19 in blood via fingerstick, using a handheld analyzer. 

The company uses a patented technology requiring a small drop of blood from the fingertip and a disposable test to provide results in approximately 15 minutes. 

The company said the order “to support the urgent needs of Brazil’s Ministry of Health” was with the Bio-Manguinhos subsidiary of the Oswaldo Cruz Foundation or Fiocruz, responsible for developing and producing vaccines, diagnostics and biopharmaceuticals, primarily for Brazil’s national public health system.

Chembio also said it will begin testing the DPP COVID-19 IgM/IgG system at multiple sites in the United States. 

“The testing program has been designed to generate the clinical validation data that Chembio needs in order to submit the DPP COVID-19 IgM/IgG System for emergency use authorization by the FDA and to commercially launch the system under new FDA guidelines,” the company said in a written statement. 

Javan Esfandari, Chembio’s chief science and technology officer, said the “test will detect the presence of antibodies in blood indicating that a person had an immune response” to COVID-19 “regardless of whether symptoms developed from infection or if the infection was asymptomatic.”

Chembio already has supplied Bio-Manguinhos with tests to detect HIV and other infectious diseases.  The company’s Brazilian subsidiary has filed for approval from ANVISA, the Brazilian health regulatory agency, for the DPP COVID-19 IgM/IgG System under that country’s emergency use authorization program.