BETHLEHEM, Pa., April 07, 2022 (GLOBE NEWSWIRE) — OraSure Applied sciences, Inc. (NASDAQ: OSUR), a world chief in point-of-care and in-home specimen assortment and diagnostic testing applied sciences, introduced at the moment at the moment its OMNIgene®The GUT Dx Microbiome Harvesting Gadget (OMD-200) has obtained de novo clearance from america Meals and Drug Administration (FDA) and the corporate is launching the gadget commercially.
ALL®GUT Dx allows the non-invasive assortment of human fecal specimens and stabilization of bacterial neighborhood DNA for subsequent microbiome profiling evaluation by an assay validated to be used with OMNIgene®GOOD Dx.
“This innovation will help our prospects as they search to provoke microbiome-based medical trials or therapies and search the reliability of an FDA-cleared gadget. Given the innovation within the subject, we consider we’re about to see a lot of FDA-cleared therapeutics and diagnostics utilizing microbiome biomarkers,” stated Kathleen Weber, President of Molecular Options for OraSure Applied sciences. “Microbiome therapies and diagnostics have the potential to assist healthcare suppliers deal with and forestall illness on a extra personalised stage, and OraSure is positioning itself as a pacesetter within the microbiome area. »
DNA Genotek has a confirmed observe report in supporting corporations providing diagnostic assessments within the subject of human genomics. Their portfolio of microbiome assortment units is utilized in over 90 nations and has been featured in over 200 scientific publications so far.
About OraSure Applied sciences
OraSure Applied sciences allows the worldwide neighborhood to enhance well being and well-being by offering entry to correct and important data. OraSure, with its wholly owned subsidiaries, DNA Genotek, Diversigen and Novosanis, gives its prospects with end-to-end options that embody instruments, companies and diagnostics. The OraSure household of corporations is a pacesetter within the improvement, manufacture and distribution of speedy diagnostic assessments, pattern assortment and stabilization units and molecular service options designed to find and detect important medical situations. OraSure’s product portfolio is offered worldwide to medical laboratories, hospitals, medical practices, clinics, public well being and neighborhood organizations, analysis institutes, authorities companies, pharmaceutical corporations, industrial entities and on to customers. For extra details about OraSure Applied sciences, please go to www.orasure.com.
About Genotek DNA
DNA Genotek Inc., a subsidiary of OraSure Applied sciences, Inc., is concentrated on offering prime quality organic pattern assortment merchandise and end-to-end companies for human genomics and microbiome purposes. The Oragene of society®• Dx and ORAcollect®• The Dx product strains are the primary and solely saliva-based DNA assortment units FDA 510(okay) cleared for in vitro diagnostic use. DNA Genotek additionally provides research-only merchandise for accumulating and storing giant quantities of DNA or RNA from a number of pattern varieties. DNA Genotek markets its merchandise worldwide and has a world buyer base with 1000’s of consumers in over 100 nations. For extra details about DNA Genotek, go to www.dnagenotek.com
This press launch incorporates sure forward-looking statements, together with with respect to the Firm’s merchandise, product improvement actions, regulatory submissions and clearances and different issues. Ahead-looking statements usually are not ensures of future efficiency or outcomes. Recognized and unknown elements that would trigger precise efficiency or outcomes to vary materially from these expressed or implied by such statements embrace, however usually are not restricted to: the chance that the Firm’s exploration of strategic alternate options won’t lead to any definitive transaction or improve shareholder worth and should create distraction or uncertainty that would adversely have an effect on outcomes of operations, enterprise or investor notion; the diversion of administration’s consideration from the corporate’s day-to-day operations and common enterprise obligations because of the firm’s exploration of strategic alternate options; skill to unravel the corporate’s ongoing manufacturing challenges and meet buyer demand; skill to market and promote merchandise, whether or not by our inner direct gross sales drive or third events; the affect of great buyer focus within the genomics trade; failure of distributors or different prospects to fulfill buy forecasts, historic buy ranges or minimal buy necessities for our merchandise; skill to fabricate merchandise in accordance with relevant specs, efficiency requirements and high quality necessities; the flexibility to acquire, and the timing and price of acquiring, essential regulatory approvals for brand spanking new merchandise or new indications or purposes for present merchandise; skill to adjust to relevant regulatory necessities; skill to successfully resolve warning letters, audit observations, and different findings or feedback from america Meals and Drug Administration (“FDA”) or different regulatory companies; the affect of the novel coronavirus (“COVID-19”) pandemic on the Firm’s enterprise and its skill to efficiently develop new merchandise, validate the expanded use of present assortment merchandise, obtain approvals and essential regulatory authorizations and to market these merchandise for COVID-19 testing; adjustments in relationships, together with disputes or disagreements, with strategic companions or different events and reliance on strategic companions to carry out important actions beneath collaborative preparations; skill to fulfill elevated demand for the Firm’s merchandise; affect of changing distributors; stock ranges at distributors and different prospects; the Firm’s skill to realize its monetary and strategic goals and to proceed to extend its revenues, together with the flexibility to increase its worldwide gross sales; the affect of rivals, competing merchandise and technological adjustments; discount or postponement of public funding out there to prospects; competitors from new or improved applied sciences or decrease value merchandise; skill to develop, market and market new merchandise; market acceptance of saliva or urine assessments, swabs or different merchandise; market acceptance and adoption of microbiome informatics, microbial genetics know-how and associated analytical companies; adjustments in market acceptance of merchandise primarily based on product efficiency or different elements, together with adjustments in testing tips, algorithms or different suggestions by the Facilities for Illness Management and Prevention (“ CDC”) or different companies; skill to fund analysis and improvement and different merchandise and operations; skill to acquire and preserve distribution channels for brand spanking new or present merchandise; dependence on single sources of provide for important merchandise and elements; the provision of associated merchandise manufactured by third events or merchandise essential for the usage of our merchandise; the affect of US authorities contracts; affect of adverse financial situations; skill to keep up sustained profitability; skill to make the most of internet working losses carried ahead or different deferred tax property; the volatility of the value of the Firm’s shares; uncertainty regarding patent safety and potential patent infringement claims; the uncertainty and prices of litigation regarding patents and different mental property rights; availability of patent or different know-how licenses; skill to enter into worldwide manufacturing agreements; obstacles to worldwide advertising and manufacturing of merchandise; skill to promote merchandise internationally, together with the affect of adjustments in worldwide funding sources and testing algorithms; antagonistic actions in international forex alternate charges; loss or impairment of capital sources; skill to draw and retain certified personnel; publicity to product legal responsibility and different sorts of litigation; adjustments in worldwide, federal or state legal guidelines and rules; buyer groupings and stock practices; gear failures and the flexibility to acquire essential uncooked supplies and elements; the affect of terrorist assaults and civil unrest; and normal political, industrial and financial situations. These and different elements that would have an effect on our outcomes are mentioned in additional element in our filings with the SEC, together with our registration statements, our Annual Report on Type 10-Ok for the fiscal yr ended December 31, 2021 , our quarterly reviews on Type 10-Q and different filings. with the SEC. Though forward-looking statements assist present details about future prospects, readers needs to be conscious that forward-looking statements will not be relied upon. Readers are cautioned to not place undue reliance on forward-looking statements. Ahead-looking statements are made as of the date of this press launch and OraSure Applied sciences undertakes no obligation to replace such statements.