OraSure’s Oragene(R)?Dx Saliva Assortment Package Provided in Industry’s Initial Fda Authorization for a Full Exome Sequencing System

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BETHLEHEM, Pa., Jan 21, 2021 (World NEWSWIRE by using COMTEX) —
BETHLEHEM, Pa., Jan. 21, 2021 (Globe NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a chief in point-of-treatment diagnostic assessments, specimen collection devices, and microbiome laboratory and analytical companies, today introduced that its Oragene(R)?Dx (OGD-610) saliva collection machine was integrated as a component in the De Novo authorization granted by the U.S. Food items & Drug Administration (Food and drug administration) to Helix for their Helix(R) Laboratory System1, a total exome sequencing system. This is the very first exome sequencing-dependent system licensed by the Food and drug administration. Oragene(R)?Dx is a merchandise of OraSure’s DNA Genotek subsidiary.

Oragene(R)?Dx (OGD-610) was also incorporated as a element in the 510(k) clearance Helix been given for its Helix(R) Genetic Wellbeing Danger App2 for late-onset Alzheimer’s Sickness for over-the-counter use – the very first take a look at to be cleared on the Helix(R) Laboratory System.

“The inclusion of our Oragene(R)?Dx saliva selection system in the Food and drug administration authorization granted to Helix for the to start with and only complete exome sequencing platform highlights how genetic check companies providing diagnostic testing can confidently use our products inside of their protocols,” claims Kathleen Weber, Govt Vice President Molecular Alternatives. “This will save time and value for diagnostic corporations that want to leverage an Food and drug administration-cleared saliva assortment device into their methodologies for both supervised (i.e. prescription) and unsupervised at house assortment. The team at DNA Genotek congratulates Helix on this important operate.”

In 2020, Oragene(R)?Dx obtained U.S. Food stuff and Drug Administration (Fda) normal use 510(k) clearance and continues to be the initially and only unit with standard clearance for selection and stabilization of DNA from saliva for use in genetic tests, including prescription or over-the-counter (immediate-to-client) use. Saliva samples collected using Oragene(R)?Dx are stabilized for use in downstream diagnostic testing applications and can be transported and/or saved extensive-expression at ambient temperatures.

“Now, much more than at any time, it’s critical to supply non-invasive, at-home sample collection for scientific tests,” stated Marc Laurent, VP of Functions and Partnerships, Helix. “DNA Genotek’s product and guidance were being an significant aspect of our initiatives to acquire Fda authorization. We are happy to have worked with the group at DNA Genotek and to include the Oragene(R)?Dx saliva assortment gadget in our Fda authorization.”

This Fda Authorization tends to make it doable for Helix and its companions to establish and get market authorization for potential tests using subsets of sequencing knowledge created from the Helix(R) Laboratory System, which includes for cancer, cardiovascular disorder, and provider screening.

About OraSure Systems
OraSure Technologies empowers the global community to make improvements to well being and wellness by furnishing accessibility to precise, crucial information. OraSure, collectively with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, gives its buyers with end-to-finish answers that encompass resources, expert services and diagnostics. The OraSure family of organizations is a leader in the development, manufacture, and distribution of quick diagnostic tests, sample assortment and stabilization equipment, and molecular expert services remedies created to uncover and detect essential health-related circumstances. OraSure’s portfolio of products and solutions is bought globally to clinical laboratories, hospitals, physician’s workplaces, clinics, community well being and group-dependent corporations, exploration institutions, govt companies, pharma, industrial entities and direct to buyers. For a lot more info about OraSure, go to www.orasure.com

About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing substantial-top quality organic sample selection merchandise and finish-to-end services for human genomics and microbiome purposes. The Firm’s Oragene(R)?Dx and ORAcollect(R)?Dx product traces are the 1st and only Food and drug administration 510(k) cleared saliva-primarily based DNA selection units for in vitro diagnostic use. DNA Genotek also offers Research Use Only products and solutions to acquire and maintain significant amounts of DNA or RNA from many sample sorts. DNA Genotek markets its solutions around the globe and has a world buyer base with 1000’s of customers in around 100 nations. For much more information and facts about DNA Genotek, take a look at www.dnagenotek.com

About Helix
Helix is the foremost population genomics corporation functioning at the intersection of medical care, exploration, and genomics. Its finish-to-finish system allows health devices, lifetime sciences businesses, and payers to progress genomic study and speed up the integration of genomic info into clinical treatment. Driven by a single of the world’s greatest CLIA / CAP next-technology sequencing labs and the very first and only Fda licensed entire exome sequencing system, Helix supports all features of populace genomics including recruitment and engagement, clinically actionable illness screening, return of success, and simple and translational investigation. In response to the COVID-19 public health and fitness disaster, Helix has launched a delicate and scalable finish-to-close COVID-19 examination technique to satisfy the requires of overall health methods, employers, governments, and other corporations across the country. Find out additional at www.helix.com.


1 The Helix(R) Laboratory System is a qualitative in vitro diagnostic unit meant for exome sequencing and detection of solitary nucleotide variants (SNVs) and small insertions and deletions (indels) in human genomic DNA extracted from saliva samples gathered with Oragene(R)?Dx (OGD-610).

2 The Helix(R) Genetic Wellbeing Threat Application takes advantage of qualitative genotyping to detect clinically applicable variants in genomic DNA isolated from human saliva collected from folks bigger-than or equivalent to18 several years with Oragene(R)?Dx OGD-610 for the objective of reporting and decoding Genetic Wellbeing Dangers (GHR).


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