Press Release Details

Quest Diagnostics Introduces HPV High-Risk Reflex Testing for Inconclusive ThinPrep Pap Tests


TETERBORO, N.J., June 23, 2000 —

In March 2000, the U.S. Food and Drug Administration approved the use of this DNA-based technology, which detects the 13 key types of human papillomavirus that indicate a high risk of developing cervical cancer, as a follow-up to patients whose Pap tests have inconclusive, or "ASCUS," results. ASCUS, or Atypical Squamous Cells of Undetermined Significance, is a category of Pap test results that typically occurs in three to five per cent of patients. It is a source of frustration for clinicians because of the uncertainty about what they should do next for their patients, which sometimes results in further treatment that is costly and, possibly, unnecessary.

"We are now able to reduce the uncertainty for patients and their doctors that is associated with ASCUS results," said Joy Nassif, Vice President of Anatomic Pathology. "Quest Diagnostics is the first laboratory to offer this advanced high risk DNA test as a reflex from the ThinPrep specimen vial, potentially saving the patient another visit to her gynecologist."

As an established technology, HPV testing is currently covered by Medicare and many other health care plans. Quest Diagnostics is working with major insurers to review current coverage in light of the additional volumes of testing expected, coupled with lower anticipated volumes of repeat Pap tests and other diagnostic procedures such as colposcopies and biopsies. In a May 1999 article in the Journal of the American Medical Association, researchers at Kaiser Permanente (Manos and Kinney) validated the potential for improved patient care at lower cost through this combination of reflex testing. Preliminary information from the National Cancer Institute’s "ASCUS Low-Grade Triage Study" (ALTS) indicates this may be the preferred approach for clinicians in the future.

An independent market survey conducted by Quest Diagnostics in the Fall of 1999 indicated that physicians who supplemented Pap testing with HPV tests on ASCUS results performed fewer repeat Pap tests, colposcopies and biopsies. Nearly all of the participants in the survey foresaw increased utilization of HPV testing as more clinical data becomes available.

Until now, physicians were required to place a separate order for HPV testing, which included detection of both high-risk and low-risk viral subtypes at twice the cost. By making the new high-risk HPV DNA test offering available as a reflex to ASCUS ThinPrep Pap Test results, patients with ASCUS results receive the double benefit of only requiring one specimen, and not having to wait for months for re-testing. Traditionally, when a second specimen is required following an abnormal result, patients are required to wait three to six months for a repeat Pap test to avoid false-negative results. With the additional HPV information, physicians can decide to proceed directly to additional treatment or return the patient to periodic screening.

"We feel the recent FDA approval for the high-risk HPV DNA test, along with the growing body of clinical data showing the benefits of immediate follow-up of ASCUS Pap results with this test, provides a clear opportunity for improved health care for our female patients," said Dr. Harvey W. Kaufman, Chief Laboratory Officer for Quest Diagnostics. "By performing this single-probe test from the ThinPrep vial, we are able to provide a unique combination of better treatment for patients in a more cost effective manner for insurance carriers.

"The ability to reduce the uncertainty associated with waiting months for additional testing, or having additional procedures such as a colposcopy performed when it may not be necessary, is a tremendous step forward in women's health care," Dr. Kaufman continued. "Quest Diagnostics is continuously seeking ways to improve the quality of life for women through improved screening and diagnostic information."

Quest Diagnostics is the nation's leading provider of diagnostic testing, information and services with annualized revenues of more than $3 billion. The testing performed on human specimens helps doctors diagnose, treat and monitor disease; enables employers to detect workplace drug abuse; and supports pharmaceutical and biotechnology companies in clinical trials of new therapeutics worldwide. Quest Informatics analyzes laboratory and other medical data to help health care providers improve the care of patients. Additional company information can be found on the Internet at:

ThinPrep is a registered trademark and ThinPrep Pap Test is a trademark of Cytyc Corporation.