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HealthEast Medical Laboratory (HML) announces the implementation of the new molecular diagnostic testing for the Human Papilloma Virus (HPV) infections of the female genital tract.
HML is partnering with Access Genetics to bring Polymerase Chain Reaction (PCR) HPV testing in-house. The methodology we currently use, Digene Hybrid Capture II (HCII) (performed at Mayo Medical Laboratories), simply screens for the presence of High or Low Risk HPV. The PCR methodology will not only tell the clinician if the patient is positive or negative for high and/or low risk HPV, it will also pinpoint the specific genotype(s) of HPV to which the patient has been exposed.
This detailed information can help the clinician determine how to assess the patient's risk for cervical cancer and the course of treatment. The test will be reported out as either "Negative for HPV" or "Positive for HPV" and the individual genotype(s) identified.
As HML gets closer to the determined implementation date, more details will follow on ordering and pricing information. If you have questions or concerns, contact Customer Service at 651-232-3500 or Scott Lindrud, Cytology Section Supervisor, at 651-232-4235.
Information sheets:
Note:
PCR testing has not been cleared and approved by the FDA whereas Digene's HCII method has. The FDA has determined that such clearance is not necessary for this test as long as its performance characteristics have been evaluated. This assay was developed by Access Genetics and its performance characteristics have been determined by HealthEast. Our laboratory is regulated under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 and the College of American Pathologists (CAP) and is qualified to perform this type of high complexity testing.
