OraSure's HCV test gets a boost thanks to an FDA nod to expand the promotion and use of the test, which will be co-marketed by Merck. The test is said to be able to determine HCV positivity within 20 minutes. The approval should also be a boon to both Merck, Vertex and near-term HCV DAA developers as this is an opportunity to expand the pool of treatable patients
OraSure gets wider use for hep C test, shares up
* Test can check for hepatitis C virus in 20 minutes
* OraSure shares up 8.8 percent
Nov 29 (Reuters) - OraSure Technologies received approval to sell its test for the hepatitis C virus to a wider range of clinics and doctors' offices in the United States, sending shares of the company up nearly 9 percent.
The company said on Tuesday the Food and Drug Administration expanded approval for the OraQuick HCV test, allowing more than 180,000 facilities to use it for detecting the serious liver disease in patients.
The FDA approved the test in February, but initially limited its use to clinically trained staff.
The test for the virus can be done via blood samples taken from a vein, or with a finger-stick test, which draws a tiny amount of blood by pricking the finger.
OraSure, based in Bethlehem, Pennsylvania, said patients can get a diagnosis in 20 minutes.
About 4 million people in the United States, and 180 million worldwide, are infected with the hepatitis C virus, the company said. Untreated, hepatitis C can lead to chronic liver disease, liver cancer and the need for a liver transplant.
Infections with the hepatitis C virus are not generally obvious. In most cases there may be no symptoms for years while the hepatitis quietly damages the liver until it is finally diagnosed.
"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," Dr. Willis Maddrey, president of the Chronic Liver Disease Foundation said in a statement provided by OraSure.
Vertex Pharmaceuticals and Merck & Co both received approval to market new hepatitis C drugs earlier this year. The market for such drugs is estimated to be worth about $15 billion by 2019, and both companies are conducting campaigns to raise awareness of the disease.
An increase in hepatitis C testing should help boost sales of the new medicines.
Merck will help promote the OraQuick HCV test in doctors' offices as part of a collaboration agreement, OraSure said.
OraSure shares closed up 69 cents, or 8.8 percent, to $8.55 on Nasdaq.
Showing posts with label OraSure. Show all posts
Showing posts with label OraSure. Show all posts
Tuesday, November 29, 2011
Friday, March 25, 2011
OraSure Technologies seeks to expand laboratory access to OraQuick(R) HCV Rapid Test
BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody Test for use with venous whole blood and fingerstick whole blood specimens.
The OraQuick® HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus and is currently classified as a moderately complex test which can be used by approximately 40,000 laboratories certified as meeting certain quality and training requirements under CLIA. According to the Centers for Medicaid and Medicare Services, if the CLIA waiver application is approved, the OraQuick® HCV test could then be available for use by more than 180,000 sites nationwide, including those that can perform CLIA-waived tests such as outreach clinics, community-based organizations and physician offices.
"If approved, a CLIA waiver would enable greater access to a test that could play a vital role in identifying HCV infection in the United States," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Most importantly, the CLIA waiver will enable healthcare providers, those on the front lines of fighting this disease, to identify more individuals infected with hepatitis C and connect them to care and treatment."
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
The OraQuick® HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus and is currently classified as a moderately complex test which can be used by approximately 40,000 laboratories certified as meeting certain quality and training requirements under CLIA. According to the Centers for Medicaid and Medicare Services, if the CLIA waiver application is approved, the OraQuick® HCV test could then be available for use by more than 180,000 sites nationwide, including those that can perform CLIA-waived tests such as outreach clinics, community-based organizations and physician offices.
"If approved, a CLIA waiver would enable greater access to a test that could play a vital role in identifying HCV infection in the United States," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Most importantly, the CLIA waiver will enable healthcare providers, those on the front lines of fighting this disease, to identify more individuals infected with hepatitis C and connect them to care and treatment."
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
Tuesday, February 22, 2011
FDA OKs OraSure's OraQuick HCV Rapid Test...
BETHLEHEM, Pa., Feb. 22, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick® HCV Rapid Antibody Test has now been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting 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 product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.
The OraQuick® HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick® technology platform, provides results in 20 minutes.
"Receiving FDA approval to test individuals at risk using a fingerstick whole blood sample significantly expands the flexibility and versatility of our OraQuick® Rapid HCV Antibody Test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "By eliminating the need for a blood draw, healthcare providers will be able to identify more individuals infected with hepatitis C and get them into care."
There are an estimated 4.1 million Americans, or 1.6 percent of the U.S. population, that are or have been infected with HCV. New infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
The Company previously received approval to affix the CE mark to its OraQuick HCV test in December 2009 for use with oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. The CE Mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (NYSE:MRK), through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick 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.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
The OraQuick® HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick® technology platform, provides results in 20 minutes.
"Receiving FDA approval to test individuals at risk using a fingerstick whole blood sample significantly expands the flexibility and versatility of our OraQuick® Rapid HCV Antibody Test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "By eliminating the need for a blood draw, healthcare providers will be able to identify more individuals infected with hepatitis C and get them into care."
There are an estimated 4.1 million Americans, or 1.6 percent of the U.S. population, that are or have been infected with HCV. New infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
The Company previously received approval to affix the CE mark to its OraQuick HCV test in December 2009 for use with oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. The CE Mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (NYSE:MRK), through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick 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.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
Friday, June 25, 2010
OraQuick® HCV Rapid Antibody Test approved for sale in the US...
OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S.
GlobeNewswire - Jun. 25, 2010
BETHLEHEM, Pa., June 25, 2010 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick® Hepatitis C ("HCV") Rapid Antibody Test has been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.
"The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," said Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School of Medicine. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."
"We believe that the OraQuick® HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Obtaining FDA approval of our OraQuick® HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company."
OraQuick® HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick® technology platform, provides results in 20 minutes. The OraQuick® HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.
In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention ("CDC"), new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.
In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick® HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market in those countries in which the Company has obtained approval.
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