OraSure’s OMNIgene®·ORAL Device Included in EUA Amendment Granted to 3B BlackBio Biotech India for SARS-CoV-2 Test
December 23 2020 - 06:00AM
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices, and
microbiome laboratory and analytical services, today announced that
its OMNIgene®·ORAL (OM/OME-505) collection device was included in
the U.S. Food and Drug Administration (FDA) Emergency Use
Authorization (EUA) amendment granted to 3B BlackBio Biotech, one
of the leading suppliers and developers for RT-PCR diagnostic
assays in India. This is the seventh customer EUA that includes a
collection device from the company’s DNA Genotek subsidiary.
This EUA amendment will allow 3B BlackBio
Biotech’s North American distributor, Genophyll Enterprises, to
expand saliva COVID-19 PCR-based viral diagnostic testing across
the U.S. as well as from their upcoming New Jersey-based
laboratory.
This EUA amendment granted to 3B BlackBio
Biotech includes the addition of qualitative detection of nucleic
acid from SARS-CoV-2 in saliva specimens that are collected with
the assistance of a healthcare provider (HCP) using the
OMNIgene·ORAL (OM-505/OME-505) saliva collection device by
individuals suspected of COVID-19. The 3B BlackBio Biotech
SARS-CoV-2 assay, combined with OMNIgene·ORAL, facilitates the
detection of nucleic acid from SARS-CoV-2 samples using highly
sensitive quantitative PCR technology. A product of OraSure’s DNA
Genotek subsidiary, OMNIgene·ORAL saliva collection devices are
intended for use by individuals to collect and immediately
stabilize saliva specimens suspected of containing SARS-CoV-2
ribonucleic acid (RNA) at ambient temperature for transport.
“A saliva-based collection method for COVID-19
laboratory tests is a valuable addition to our testing portfolio
for helping diagnose SARS-CoV-2 infection,” said Aditi Luthra, CEO,
Genophyll Enterprises. “Now, Genophyll Enterprises has access to a
robust and safe biomaterial collection approach for the detection
of COVID infections. This expansion of testing methods is critical
to informing patient management decisions and containing the spread
of COVID-19.”
“As the pandemic evolves, the need for testing
continues to grow," said Kathleen Weber, Executive Vice-President,
Business Unit Leader, Molecular Solutions at DNA Genotek. “The
addition of OMNIgene·ORAL to 3B BlackBio Biotech’s EUA expands
access to saliva-based collection to more individuals, which will
result in more testing and help provide the confidence we need to
help get back to living with more normalcy."
“3B BlackBio Biotech aims at fulfilling the
current demand of higher testing and has stepped up its production
capacity for RT-PCR kit for SARS-CoV-2 detection. Our kit coupled
with the Saliva Specimen Collection Device of OraSure’s DNA Genotek
will make the sampling easier for the healthcare service provider
(HCP) and will also reduce the patient’s discomfort,” said
Dhirendra Dubey, Managing Director, 3B BlackBio Biotech India
Limited.
About OraSure Technologies
OraSure Technologies empowers the global community to improve
health and wellness by providing access to accurate, essential
information. Together with its wholly-owned subsidiaries, DNA
Genotek, Diversigen, CoreBiome (now operating under the Diversigen
brand), UrSure and Novosanis, OraSure provides its customers
with end-to-end solutions that encompass tools, services and
diagnostics. The OraSure family of companies is a leader
in the development, manufacture, and distribution of rapid
diagnostic tests, sample collection and stabilization devices, and
molecular services solutions designed to discover and detect
critical medical conditions. OraSure’s portfolio of products is
sold globally to clinical laboratories, hospitals, physician’s
offices, clinics, public health and community-based organizations,
research institutions, government agencies, pharma, commercial
entities and direct to consumers. For more information
on OraSure Technologies, please
visit www.orasure.com.
About DNA GenotekDNA Genotek
Inc., a subsidiary of OraSure Technologies, Inc., focuses on
providing high-quality biological sample collection products and
end-to-end services for human genomics and microbiome applications.
The Company's Oragene®•Dx and ORAcollect®•Dx product lines are the
first and only FDA 510(k) cleared saliva-based DNA collection
devices for in vitro diagnostic use. DNA Genotek also offers
Research Use Only products to collect and preserve large amounts of
DNA or RNA from multiple sample types. DNA Genotek markets its
products worldwide and has a global customer base with thousands of
customers in over 100 countries. For more information about DNA
Genotek, visit www.dnagenotek.com.
About 3B BlackBio Biotech3B
BlackBio Biotech, a subsidiary of Kilpest India Limited (a publicly
traded company), is a leading Indian manufacturer of molecular
diagnostic kits. 3B BlackBio Biotech produces the FDA EUA
authorized TRUPCR SARS-CoV-2 kit. The TRUPCR SARS-CoV-2 kit is a
highly sensitive, comprehensive three gene detection assay (E,
RdRp, N genes). In addition to its FDA Emergency Use Authorization,
the kit has also been validated by the Indian Council of Medical
Research, Government of India.
In addition to infectious diseases and virology,
its portfolio of assays include blood-borne diseases, vector borne
diseases, oncology, sexually transmitted infections and coagulation
panels. 3B BlackBio Biotech’s in-house enzyme production, bulk
procurement and India-based operations ensure substantial cost
advantages. The Company is ISO 13485:2016 certified and GMP
compliant. 3B BlackBio Biotech has supplied over 5.5 million tests
to over 400 satisfied customers all across India. For more
information about 3B BlackBio Biotech, visit
www.3bblackbio.com.
About GenophyllGenophyll is a
woman and minority owned small business based in New Jersey.
Genophyll is proud to partner with 3B BlackBio Biotech, the
manufacturer of FDA EUA authorized TRUPCR SARS-CoV-2 kit, to
broaden its ability to serve the North and South America. The
TRUPCR SARS-CoV-2 kit is the only Indian-made RT-PCR for the novel
coronavirus that has received Emergency Use Authorization from the
FDA. 3B BlackBio Biotech’s production capacity is 100,000 tests per
day. This fact, coupled with hands-on technical customer service
support and lower supply costs in India, uniquely positions
Genophyll to offer a high-quality, easy to use, cost-effective
solution. For more information about Genophyll, call, text, or
email us at 732-945-0190 and mail@genophyll.us.
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