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Quest Diagnostics Introduces First Commercial Laboratory Test for Identifying the H1N1 Swine Flu Virus

Posted on: Monday, 11 May 2009, 20:38 CDT

Real-time PCR test validated using clinical specimens confirmed

positive for Influenza A H1N1 Swine-origin flu virus

MADISON, N.J., May 11 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that its Focus Diagnostics infectious disease reference laboratory has introduced a laboratory-developed real-time polymerase chain reaction (PCR) test to aid in identifying Influenza A H1N1 Swine-origin (H1N1) flu virus ("S-OIV" or "novel H1N1"), also known as the Swine Flu. The Focus Diagnostics Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test is the first laboratory testing service to be introduced by a commercial laboratory to aid in the identification of patients infected with the novel H1N1 virus and differentiate patients infected with other seasonal Influenza A strains. Focus Diagnostics has a track record of being first to market with new laboratory testing services for emerging infectious diseases, such as West Nile Virus, SARS, and chikungunya virus.

"Our new laboratory test will be an important tool to help health care professionals and public health authorities identify infected patients more quickly, promoting earlier diagnosis and treatment," said Jon R. Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics. "This capability could be particularly important if the novel H1N1 virus continues to spread in the U.S. or re-emerges this fall or winter. Public health officials in the U.S. have done an exceptional job of managing the current Influenza emergency, and we continue to work closely with them to assist their preparedness efforts."

Focus Diagnostics validated its new Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test using clinical specimens submitted to its reference laboratory confirmed as positive for the novel H1N1 influenza virus by public health authorities. Real-time PCR is a highly sensitive testing technique that can detect the presence of a virus' RNA from a patient's nasal or nasopharyngeal specimen. The S-OIV virus responsible for a recent outbreak affecting dozens of countries is a subtype of Influenza virus Type A. The new Focus Diagnostics test simultaneously detects the presence of Influenza A virus RNA and specifically identifies the presence of the novel H1N1 virus.

Focus Diagnostics will perform the Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR laboratory test, in alignment with current public health guidelines, at its reference laboratory in Cypress, California. Physicians, hospitals and other health care practitioners may order the laboratory test directly from Focus Diagnostics or through the Quest Diagnostics national laboratory network. Expected turnaround time for reporting results is within 24 hours of receipt of specimen by the Focus Diagnostics laboratory.

In addition to the new Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test, Quest Diagnostics' regional laboratories, including the Focus Diagnostics reference laboratory, perform a broad range of testing services to detect Influenza viruses, including PCR, rapid cell culture, direct immunofluorescence (DFA) and enzyme immunoassay (EIA) techniques. Depending on the laboratory, the company can perform testing on different types of collected specimens, such as nasopharyngeal swabs, nasal secretions, nasal wash (lavage) and aspirations.

Public health guidelines are governed at the federal, state and county level, and vary across the U.S. While state and county public health guidelines initially required private clinical laboratories to provide positive Influenza virus type A positive specimens to public health authorities for confirmatory testing and diagnosis of novel H1N1 virus infection, some state and county public health authorities now only require confirmatory testing for specimens from certain high risk patients or under certain circumstances.

With the availability of the Focus Diagnostics Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test, physicians will be able to submit patient specimens that are found to be positive for Influenza virus type A through testing performed by a Quest Diagnostics' regional laboratory or other private clinical laboratory to Focus Diagnostics' reference laboratory for novel H1N1 laboratory testing. A physician that believes a patient is at high risk of novel H1N1 infection may order the new Focus Diagnostics test to aid the diagnosis of Influenza virus type A infection, including the novel H1N1 virus. Focus Diagnostics would also submit those test specimens found to be positive as well as the test results to the appropriate public health authorities, as required by local public health guidelines.

"The availability of the new Focus Diagnostics laboratory test will enable physicians and hospitals to quickly identify patients infected with S-OIV and differentiate them from patients infected with other Influenza A strains," said Jay M. Lieberman, M.D., medical director, Focus Diagnostics. "We will continue to aid our public health colleagues in responding to the H1N1 outbreak, and encourage clinicians to follow testing guidelines provided by public health authorities."

Focus Diagnostics has collaborated with the U.S. Centers for Disease Control and Prevention, the World Health Organization and other public health agencies to help identify and develop diagnostic tests for emerging infectious diseases. Focus Diagnostics was instrumental in developing the first laboratory developed test for West Nile Virus after it was identified in New York in 1999. Focus Diagnostics also introduced the first laboratory developed test for SARS and the first FDA-cleared serological test kit for Lyme disease.

For more information about Quest Diagnostics and Influenza testing options, please visit www.QuestDiagnostics.com/SwineFlu.

About Focus Diagnostics

Focus Diagnostics, Inc. is an infectious disease diagnostics company, providing infectious disease reference laboratory services to hospitals and laboratories nationwide, and manufacturing and distributing diagnostic products worldwide. Focus Diagnostics develops innovative tests and products to assist physicians in diagnosing infectious diseases, and often provides the first diagnostic tests in the U.S. for emerging diseases, such as West Nile Virus and SARS. HerpeSelect(R) type-specific HSV serology and West Nile Virus DxSelect(TM) are top-selling Focus Diagnostics products used in laboratories worldwide. Focus Diagnostics is a wholly owned subsidiary of Quest Diagnostics. Visit www.focusdx.com for additional information.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.questdiagnostics.com.

SOURCE Quest Diagnostics Incorporated

Source: PR Newswire

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