BETHLEHEM, Pa., Nov. 25, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it is reaffirming its fourth quarter 2013 financial guidance, which the Company last updated in a press release it issued on November 21, 2013.
This reaffirmation is being made after the Company learned today that a customer of its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration (FDA) requesting that this customer immediately discontinue marketing its service in the U.S. This customer represented less than 5 percent of OraSure's 2013 consolidated net revenues through September 30, 2013.
The Company continues to believe its consolidated net revenues will range from $27.5 to $28.0 million and that its consolidated net income will be approximately $0.07 - $0.08 per share for the fourth quarter of 2013.About OraSure Technologies OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration for the Company's OraQuick® In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market - making it the first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. 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, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.
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