Esoterix Molecular Genetics Introduces New Early Detection Tool For HPV - A Cervical Cancer Precursor
MINNEAPOLIS, MN -- (INTERNET WIRE) -- 08-01-2002 -- Esoterix Molecular Genetics announced today the launch of a new two-step approach for the detection and identification of HPV (Human Papillomavirus). HPV is the most common sexually transmitted disease, with 24 million people in the United States currently infected and up to one million new infections occurring each year. HPV is one of the most understood viruses linked to human cancer and is now recognized as the major cause of cervical cancer.
An abnormal Pap test is a red flag for HPV infection. Nearly two million of the fifty-five million Pap examinations conducted annually in the United States are returned with an indication of atypical squamous cells of undetermined significance, or ASCUS. The National Institute of Health recommends HPV screening after any abnormal or ASCUS Pap. Two recent studies (Gynecologic Oncology, November 2001 and Journal of Pathology, October 2001) support the effectiveness of testing for HPV in cervical cancer screening programs.
HPV analysis requires a two step process; detection followed by HPV type identification. While most labs combine the assays, Esoterix offers HPVdetX and HPVIDx, a two step assay. The patient is only charged for one assay if the second assay is not warranted.
HPVdetX is Esoterix's step one in the HPV diagnostic assay. HPVdetX utilizes highly sensitive Polymerase Chain Reaction (PCR) to detect the presence of HPV. HPVIDx is Esoterix's second step. Using PCR technology, HPVdetX allows for the detection of HPV DNA in an individual's sample, while HPVIDx genotypes for 48 published viral types by utilizing Restriction Fragment Length Polymorphism (RFLP) technology. HPVdetX and HPVIDx also detects types without a published or unknown restriction enzyme band pattern, further assisting in the early detection of the disease.
A positive HPVdetX result may be reflexed to HPVIDx for precise identification. The ability to perform HPVdetX with reflex to HPVIDx eliminates the need for a second office visit and specimen collection.
In addition to patient cost savings and convenience, Esoterix HPVdetX and HPVIDx increase the detection rate of HPV infection to 95% versus the 79% provided by a Pap smear.
"HPVIDx uses genotyping that provides the specific virus category enabling patient history to begin and lends to advanced knowledge for appropriate treatment options," explains Ron McGlennen, MD, who leads Esoterix Molecular Genetics. "The combination of HPVdetX and HPVIDx will detect the virus in vitro and in vivo stages, providing comprehensive results for the management of ASCUS Pap smears."
Another benefit of the Esoterix HPV product line is that the test can be performed on a broad spectrum of samples: traditional Pap, monolayer Pap smear, fresh or paraffin embedded biopsy, cyto brush submission or Dacron swab.
Founded in 1995, Esoterix, Inc. is a unique company providing technology-based laboratory services and information solutions to enhance healthcare providers' ability to manage and care for patients. Esoterix's testing services include expertise in Allergy and Asthma, Coagulation/Hematology, Endocrinology, Infectious Disease, Molecular Genetics, Oncology and Toxicology. Esoterix also has a central laboratory, Esoterix Center for Clinical Trials, dedicated to biopharmaceutical research. Esoterix has 590 employees and is privately funded through Behrman Capital of New York. (
www.esoterix.com)
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