The US Food and Drug Administration (FDA) has approved Gen-Probe’s Aptima human papillomavirus (HPV) assay, used to diagnose cervical cancer.
The Aptima HPV assay is an amplified nucleic acid test that detects 14 high-risk strains of HPV associated with cervical cancer and pre-cancerous lesions.
The test, approved to run on the company’s fully automated high-throughput TIGRIS instrument system, identifies messenger RNA over-expressed from two viral oncogenes that are responsible for cervical cancer.
The TIGRIS system can process up to 1,000 patient samples in a day, generating any combination of chlamydia, gonorrhoea, trichomonas or HPV test results.
The approval is backed by the data from the CLEAR trial, which demonstrated that Aptima HPV showed similar sensitivity for the detection of cervical disease as Pap testing.
See Also:
Columbia University Medical Center pathology and cell biology professor Tom Wright said that the new HPV test could make early, accurate decisions about patient care, which may prevent from developing a potentially deadly disease.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
![](/wp-content/themes/goodlife-wp-B2B/assets/images/company-profile-unit.png)
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData