Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced its launch of commercial distribution of an FDA Emergency Use Authorized, patent pending, rapid point-of-care COVID-19 antigen test for use in decentralized and traditional testing settings. Product inventory is on-hand and immediately available for shipment to Chembio customers across the United States.
The SCoV-2 Ag Detect™ Rapid Test, manufactured by InBios International, Inc., is a rapid immunoassay test authorized for use in laboratories with a CLIA waiver certification. It provides results in 20 minutes from a nasal swab and requires no instrumentation. The test can be used for both patients who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset and for asymptomatic serial testing.
“We are excited about the addition of this differentiated product to our menu of COVID-19 assays,” said Charles Caso, Vice President of Sales and Marketing for Chembio. “We are now offering U.S. customers SCoV-2 Ag Detect™, a test for COVID-19 antigens in both symptomatic and asymptomatic populations, as well as Status™ COVID-19/Flu A&B, a product that differentiates flu from COVID-19 using a single nasal swab sample. Our expanded commercial team can now offer testing solutions for CLIA waived settings and work and school settings.”
“The SCoV-2 Ag Detect™ Rapid Test complements our internal development efforts on our DPP Respiratory Panel product and our DPP SARS CoV-2 Antigen assay,” continued Mr. Caso. “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. The United States has seen a spike in 7-day average confirmed COVID-19 cases from a 2021 low of 11,651 on June 18, 2021 to 133,056 as of August 18, 2021, per the U.S. Centers for Disease Control and Prevention tracking data.”
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