Gen-Probe said this week that it has submitted a premarket approval application to the US Food and Drug Administration for its Aptima HPV assay, an amplification-based test that detects high-risk human papillomavirus infections associated with cervical cancer and precancerous lesions.
Aptima HPV detects messenger RNA from two viral oncogenes, E6 and E7, in 14 high-risk HPV types associated with cervical cancer.
Gen-Probe is seeking regulatory approval to run Aptima HPV on the company's fully automated Tigris instrument. The company said that approximately 200 such instruments are currently in use by US clinical laboratories to run Gen-Probe's molecular tests for chlamydia and gonorrhea.
The company filed the premarket approval application after completing a pivotal study called the Clinical Evaluation of Aptima HPV RNA, or CLEAR, trial, which involved more than 13,000 women undergoing routine Pap testing at 19 US clinics. The trial conducted two arms to validate clinical utility, consistent with consensus HPV testing guidelines recommended by leading US medical organizations, Gen-Probe said.
German diagnostic firm Astra Biotech this month introduced a new osteoporosis diagnostic test kit, which uses RT-PCR to detect polymorphisms in the COLIA1 and VDR genes to improve the identification of defects that result in abnormalities in bone matrix mineralization.
The osteoporosis test kit includes all necessary primers, enzymes, positive controls, and buffers for 100 assays, Astra Biotech said.
The new kit is in vitro diagnostic-compliant and is available in all European countries recognizing the CE Mark. The test kit is not yet available for sale in the US.