OraSure Technologies Receives CLIA Waiver for OraQuick(R) HCV Rapid Test

Nov. 29, 2011, 6:00 a.m. EST

BETHLEHEM, Pa., Nov 29, 2011 (GlobeNewswire via COMTEX) -- OraSure Technologies, Inc. announced today that the U.S. Food and Drug Administration ("FDA") has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick(R) HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

The OraQuick(R) HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus ("HCV"). The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes. With this waiver, the OraQuick(R) HCV test now can be used by more than 180,000 sites in the United States to test persons who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now extend to facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations and physician offices.

"Today, more than 4 million Americans are infected with hepatitis C and the vast majority do not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic."

"A CLIA waiver for our OraQuick(R) HCV test represents a critical milestone in our quest to make the test available to the widest possible range of at risk individuals in the U.S.," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The CLIA waiver will enable healthcare providers, those on the front lines of fighting this devastating disease, to use this simple and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed and treated."

As previously announced, OraSure has entered into agreements with Merck & Co. to collaborate on the development and promotion of the OraQuick(R) HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the United States and internationally. The approval of the CLIA waiver will now enable physicians to utilize the test in their office settings.

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 addition, through its wholly-owned subsidiary, DNA Genotek Inc., the Company also 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. For more information on OraSure Technologies, please visit www.orasure.com.

The OraSure Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6440 

This news release was distributed by GlobeNewswire, www.globenewswire.com 

SOURCE: OraSure Technologies, Inc.

CONTACT:

Investor Contact:

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

Media Contact:

Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com

Source

OraQuick HCV Rapid Test Now Approved for Use With Fingerstick Whole Blood Samples

Infectious Disease Special Edition
ISSUE: MARCH 2011 VOLUME: 1

OraSure Technologies, Inc. has received FDA approval for its OraQuick HCV Rapid Antibody Test, which detects HCV antibodies with a fingerstick whole blood sample.

The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick HCV test. The first product, approved in June 2010, required venous whole blood specimens.

The OraQuick HCV Rapid Antibody Test is the first FDA-approved rapid, point-of-care test to detect antibodies to hepatitis C virus. This test eliminates the need to draw blood and provides results in 20 minutes, which may allow healthcare providers to identify more individuals infected with hepatitis C.

OraSure is partnering with Merck & Co., through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick HCV test.

For more information, visit http://www.orasure.com/.

—Based on a press release from OraSure Technologies, Inc.

Source

OraSure delays filing for oral version of hep C test

CORRECTED - UPDATE 1-OraSure delays filing for oral version of hep C test

Wed Aug 4, 2010 7:50pm EDT

(Corrects paragraphs two and six to OraQuick HCV instead of OraQuick)

* Says filing for oral version of HCV test delayed
* Says FDA commented on lower sensitivity of tests
* Q2 loss/shr $0.01 vs. est loss/shr $0.07
* Q2 rev $19.2 mln vs. est $17.5 mln

Aug 4 (Reuters) - OraSure Technologies Inc (OSUR.O) said it has delayed the filing of a new version of its recently approved hepatitis C virus test after the U.S. health regulator commented on its lower sensitivity.

The primary comments from regulators were related to the lower sensitivity of the oral fluid and fingerstick whole blood versions of the test, OraQuick HCV, compared to the venous whole blood version, which is already on the market.

The company said, based on the comments it has decided to separate the filing for the two claims.

A supplemental application for the fingerstick version was recently sent to the regulator, OraSure said, adding that the filing for the oral fluid has been delayed pending additional discussions with the U.S. Food and Drug Administration.

The company also said it is likely that more clinical data will be needed to support an oral fluid application for the test.

Marketing approval of the test in June had raised hopes of OraQuick HCV getting the nod for multiple specimen types such as oral fluid and fingerstick whole blood sample types. [ID:nSGE65O0GB]

OraSure also posted a narrower-than-expected quarterly loss on higher sales and early receipt of a milestone payment from its partner Merck & Co (MRK.N). [ID:nWNAB3728]

Shares of the company closed at $4.45 Wednesday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Unnikrishnan Nair)

Source

FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

FDA NEWS RELEASE

For Immediate Release: June 25, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

“Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

For more information:

FDA: Medical Devices
NIH: Hepatitis C
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318.htm