Shares of Chembio Diagnostics (CEMI) - Get Chembio Diagnostics, Inc. Report, a microcap diagnostic testing company, jumped Friday after the company announced the launch of commercial distribution of a Food and Drug Administration emergency-use-authorized rapid point-of-care COVID-19 antigen test.
The company said that product inventory for the SCov-2 Ag Detect Rapid Test is immediately available for shipment across the U.S.
"We believe this product is an important addition to our portfolio at a time when testing volume is increasing as Delta variant infections are on the rise," said Charles Caso, vice president of sales and marketing for Chembio.
Shares of Chembio were rising 18.4% to $3.19 a share.
The test provides results in 20 minutes from a nasal swab and requires no instrumentation. The test can be used for patients within five days of being symptomatic and asymptomatic patients.
The company said that the U.S. has seen a spike in seven-day average confirmed COVID-19 cases from a 2021 low of 11,651 on June 18 to 133,056 as of Aug. 18. The company cited Centers for Disease Control and Prevention tracking data.
The test has not been FDA cleared or approved, but has been granted emergency authorization for use by authorized laboratories.
The company is now offering its Status COVID-19/Flu product that differentiates the flu from COVID-19 using a single nasal swab sample.
"Based on recent research, we expect that the spread of COVID-19 will eventually transition from a pandemic to an endemic state, with the virus surviving among the population at a lower incidence," the company said earlier this year.
"In this scenario, coupled with the return to normalcy in society, we see COVID-19 testing remaining a crucial and integral component of broader respiratory testing."