Gen-Probe Inc has submitted a Premarket Approval Application (PMA) to the FDA for its APTIMA HPV (human papillomavirus) assay, a new molecular test that detects high-risk HPV infections that are associated with cervical cancer and precancerous lesions.
"Developing and testing our APTIMA HPV assay was our largest and most complex R&D program for a new diagnostic test, so we are very pleased to have filed for regulatory approval ahead of our year-end goal," said Carl Hull, Gen-Probe’s president and chief executive officer. "We believe our assay, if approved by the FDA, could contribute significantly to women’s health by reducing the number of ‘false positive’ HPV test results that lead to unnecessary and expensive medical procedures. From a business perspective, this regulatory submission represents the last of five we have completed in the United States this year. When approved, we expect these new products to start an important new sales growth cycle for the Company."
Gen-Probe’s pivotal study, known as the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, involved more than 13,000 women undergoing routine Pap testing at 19 U.S. clinics. The trial included two arms to validate clinical utility, consistent with consensus HPV testing guidelines recommended by leading US medical organizations. One arm enrolled women whose Pap results were classified as atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of changes associated with progression to cervical cancer. In these cases, HPV testing can help determine appropriate patient management. The other arm enrolled women over age 30 whose Pap results were normal. This arm assessed the ability of the APTIMA HPV test to identify women who were at greater risk for cervical cancer.
The APTIMA HPV assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer. More specifically, the assay detects messenger RNA (mRNA) from two viral oncogenes, E6 and E7, which are more prevalent in the severe cervical lesions likely to progress to cervical cancer. Gen-Probe believes targeting E6/E7 mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA.
The CLEAR trial is the first large study of the APTIMA HPV assay in a US patient population. Gen-Probe intends to present the results of the trial at a future medical meeting.
Gen-Probe is seeking regulatory approval to run the APTIMA HPV assay on the company’s fully automated, high-throughput TIGRIS instrument system.
Source: Gen-Probe Inc