OraSure’s Oragene®•Dx Saliva Collection Kit Included in Industry’s First FDA Authorization for a Whole Exome Sequencin...
January 21 2021 - 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 Oragene®•Dx (OGD-610) saliva collection device was included as
a component in the De Novo authorization granted by the U.S. Food
& Drug Administration (FDA) to Helix for their
Helix® Laboratory Platform1, a whole exome sequencing
platform. This is the first exome sequencing-based platform
authorized by the FDA. Oragene®•Dx is a product of OraSure’s DNA
Genotek subsidiary.
Oragene®•Dx (OGD-610) was also included as a
component in the 510(k) clearance Helix received for its
Helix® Genetic Health Risk App2 for late-onset Alzheimer’s
Disease for over-the-counter use – the first test to be cleared on
the Helix® Laboratory Platform.
“The inclusion of our Oragene®•Dx saliva
collection device in the FDA authorization granted to Helix for the
first and only whole exome sequencing platform highlights how
genetic test providers offering diagnostic testing can confidently
use our product within their protocols,” says Kathleen Weber,
Executive Vice President Molecular Solutions. “This saves time and
cost for diagnostic companies that want to leverage an FDA-cleared
saliva collection device into their methodologies for both
supervised (i.e. prescription) and unsupervised at home collection.
The team at DNA Genotek congratulates Helix on this important
work.”
In 2020, Oragene®•Dx received U.S. Food and Drug
Administration (FDA) general use 510(k) clearance and remains the
first and only device with general clearance for collection and
stabilization of DNA from saliva for use in genetic testing,
including prescription or over-the-counter (direct-to-consumer)
use. Saliva samples collected using Oragene®•Dx are stabilized for
use in downstream diagnostic testing applications and can be
transported and/or stored long-term at ambient temperatures.
“Now, more than ever, it’s important to offer
non-invasive, at-home sample collection for clinical testing,” said
Marc Laurent, VP of Operations and Partnerships, Helix. “DNA
Genotek’s product and support were an important part of our efforts
to obtain FDA authorization. We are proud to have worked with the
team at DNA Genotek and to include the Oragene®•Dx saliva
collection device in our FDA authorization.”
This FDA Authorization makes it possible for
Helix and its partners to develop and obtain market authorization
for future tests using subsets of sequencing data generated from
the Helix® Laboratory Platform, including for cancer,
cardiovascular disease, and carrier screening.
About OraSure Technologies
OraSure Technologies empowers the global community to improve
health and wellness by providing access to accurate, essential
information. OraSure, together with its wholly-owned
subsidiaries, DNA Genotek, Diversigen, and
Novosanis, 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 about OraSure, 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 Helix Helix is the
leading population genomics company operating at the intersection
of clinical care, research, and genomics. Its end-to-end platform
enables health systems, life sciences companies, and payers to
advance genomic research and accelerate the integration of genomic
data into clinical care. Powered by one of the world’s largest CLIA
/ CAP next-generation sequencing labs and the first and only FDA
authorized whole exome sequencing platform, Helix supports all
aspects of population genomics including recruitment and
engagement, clinically actionable disease screening, return of
results, and basic and translational research. In response to the
COVID-19 public health crisis, Helix has launched a sensitive and
scalable end-to-end COVID-19 test system to meet the needs of
health systems, employers, governments, and other organizations
across the country. Learn more at www.helix.com.
Investor
Contact:Sam MartinArgot
Partners212-600-1902orasure@argotpartners.com |
|
Media
Contact:Jeanne MellOraSure
Technologies484-353-1575media@orasure.com |
_____________________
1 The Helix® Laboratory Platform is a qualitative in vitro
diagnostic device intended for exome sequencing and detection of
single nucleotide variants (SNVs) and small insertions and
deletions (indels) in human genomic DNA extracted from saliva
samples collected with Oragene®•Dx (OGD-610).
2 The Helix® Genetic Health Risk App uses qualitative
genotyping to detect clinically relevant variants in genomic DNA
isolated from human saliva collected from individuals ≥18 years
with Oragene®•Dx OGD-610 for the purpose of reporting and
interpreting Genetic Health Risks (GHR).
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