DNA Genotek Announces FDA General Use Clearance for Oragene®·Dx Family of Products
22 Gennaio 2020 - 12:00PM
DNA Genotek Inc., a leading provider of sample collection kits and
end-to-end services and a wholly-owned subsidiary of OraSure
Technologies, Inc. (NASDAQ: OSUR), announced today that the U.S.
Food and Drug Administration (FDA) has granted a general use 510(k)
clearance for its Oragene®•Dx family of products.
Oragene®•Dx is intended for use in the
non-invasive collection of saliva samples for in vitro diagnostic
testing of human DNA. Oragene®•Dx is now the first and only device
with general clearance for collection and stabilization of DNA from
saliva for use in genetic testing of human germline DNA, 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.
“With this 510(k) clearance, genetic test
providers offering diagnostic testing can confidently use our
product within their test protocols without having to provide
information on Oragene®•Dx devices in their FDA submissions,” 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 in
addition to, or instead of, collecting blood samples. The clearance
reinforces DNA Genotek’s commitment to quality, regulatory
compliance – and our customers.”
About DNA Genotek
DNA 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 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, CoreBiome, Diversigen 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.
Company contact:
Roberto CucaChief Financial
Officer610-882-1820Investorinfo@orasure.com
Jeanne MellVP Corporate
Communications484-353-1575media@orasure.com
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