OSUR OraSure Technologies Inc

OraSure Technologies, Inc. (NASDAQ:OSUR) announced today that a study conducted by Human Longevity, Inc. (HLI) and published in the Journal Scientific Reports (Nature Publishing Group) on August 25, 2016 proposes the use of the OMNIgene•GUT microbiome sample collection and stabilization device sold by OraSure’s wholly-owned subsidiary, DNA Genotek Inc., in global microbiome studies.  The published report can be found online at http://www.nature.com/articles/srep31731.

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Research into the human microbiome is emerging as highly informative to our overall understanding of health and disease risk.  The article discusses the need for standardization of sample collection and stabilization to ensure accurate downstream results in microbiome studies and compares OMNIgene•GUT to existing accepted methods including use of both fresh and frozen samples. 

The HLI authors state: “Stabilization of biological samples is crucial for accurate analysis of microbiome data, and for comparison across studies.” They then conclude: “This stabilization and collection device (OMNIgene•GUT) allows for ambient temperature storage, automation, and ease of shipping/transfer of samples. The device permitted the same data reproducibility as with frozen samples, and yielded higher recovery of nucleic acids. Collection and stabilization of stool microbiome samples with the DNA Genotek collection device, combined with our extraction and WGS (whole genome sequencing), provides a robust, reproducible workflow that enables standardized global collection, storage, and analysis of stool for microbiome studies.”

"DNA Genotek is pleased to provide a broad spectrum of kits for nucleic acid collection and stabilization from multiple sample types to enable HLI’s extensive research into genomics and metagenomics,” said Brian Smith, Senior Vice President and General Manager, at DNA Genotek Inc. “We are also proud to offer HLI end-to-end logistics support through our custom kitting and fulfillment services. HLI is a thought leader in the field and we are honored that they have provided such positive feedback, supporting the use of our product in support of discoveries impacting global health and wellness.”

OMNIgene•GUT is an all in one system for the easy self-collection and stabilization of microbial DNA from feces/stool for gut microbiome profiling. The device allows for ambient temperature storage and transportation and provides a liquid sample to enable high throughput automation in a laboratory, offering reduced costs and increased consistency and standardization.

OMNIgene•GUT OMR-200 is available for sale in the USA, and is intended for research use only, not for use in diagnostic procedures. This product has not been approved or cleared by the U.S. Food and Drug Administration.  OMNIgene•GUT OM-200 is available for sale outside the U.S. and is CE marked for in vitro diagnostic use.

About DNA Genotek

DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease 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 is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.

Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com

Ron Ticho
SVP, Corporate Communications
484-353-1575
media@orasure.com