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Fast Track Diagnostics Gets CE Mark for Real-Time PCR Detection of High-Risk HPV

NEW YORK (GenomeWeb) – Siemens' Fast Track Diagnostics said today that it received CE marking for a real-time PCR assay that detects 14 human papillomavirus subtypes in high-risk patients, expanding its sexually transmitted infections portfolio.

The firm has launched a multiplex real-time PCR assay that detects HPV 16, HPV 18, and a pool of 12 other high-risk HPV subtypes, including an endogenous control.

Fernando Beils, head of the Siemens Healthineers molecular diagnostics unit, said in a statement that its new assay can enable clinicians to better diagnose and treat these high-risk strains of HPV.

The firm designed the HPV high-risk assay to meet the requirements of labs "to deliver accurate and specific diagnoses for precision medicine," added Fast Track Diagnostics General Manager Miriam Steimer. "Genotyping of HPV 16 and HPV 18 can provide valuable support in the appropriate diagnosis and follow-up testing of women at risk to develop cervical cancer."

Siemens acquired Fast Track in December for an undisclosed amount. 

HPV infection is one of the most common viral infections of the reproductive tract and is the major risk factor for the development of cervical carcinoma. From more than 150 identified subtypes of HPV, 14 high-risk subtypes are responsible for nearly all cervical cancers, and HPV 16 and 18 alone account for more than 70 percent of cases, Siemens said, citing a University of Cambridge study in the Journal of Pathology. 

Although more than 90 percent of HPV infections are resolved within two years, a small proportion of infections from any of the 14 high-risk subtypes can persist and progress into neoplastic lesions, the firm noted.