Chembio Launches Commercial Distribution of Third-Party COVID-19 Antigen Assay
August 27 2021 - 8:00AM
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.”
The SCoV-2 Ag Detect™ Rapid Test has not been FDA cleared or
approved but has been authorized by FDA under an EUA for use by
authorized laboratories. It has been authorized only for the
detection of proteins from SARS-CoV-2, not for any other viruses or
pathogens. Its emergency use is only authorized for the duration of
the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
About Chembio DiagnosticsChembio
is a leading point-of-care diagnostics company focused on detecting
and diagnosing infectious diseases, including COVID-19, sexually
transmitted disease, and fever and tropical disease. Chembio’s
products are sold globally, directly and through distributors, to
hospitals and clinics, physician offices, clinical laboratories,
public health organizations, government agencies, and consumers.
Learn more at www.chembio.com.
DPP is Chembio’s registered trademark, and the Chembio logo is
Chembio’s trademark. For convenience, these trademarks appear in
this release without ® or ™ symbols, but that practice does not
mean that Chembio will not assert, to the fullest extent under
applicable law, its rights to the trademark. SCoV-2 Ag Detect™ is a
trademark of InBios International, Inc., and Status™ is a trademark
of LifeSign LLC.
Contact: Philip Taylor Gilmartin
Group415-937-5406investor@chembio.com
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