Roche Diagnostics’ cobas 4800 HPV test gets Health Canada approval

11 June 2014 (Last Updated June 11th, 2014 18:30)

Roche Diagnostics has received approval from Health Canada for its cobas 4800 HPV (human papillomavirus) test for use as a first-line primary screening test for cervical cancer in women aged 25 and older.

Roche Diagnostics has received approval from Health Canada for its cobas 4800 HPV (human papillomavirus) test for use as a first-line primary screening test for cervical cancer in women aged 25 and older.

The company has also launched the fully automated CINtec PLUS test to enhance the detection and early intervention of pre-cancerous cervical disease.

CINtec PLUS cytology test, also approved by Health Canada, helps in identifying women with high-grade pre-cancerous cervical lesions who need immediate colposcopy.

The company's portfolio of cervical cancer screening products offers the most comprehensive strategies for cervical cancer prevention and treatment.

"If caught early, cervical cancer is one of the most preventable and curable cancers with a survival rate of more than 90%."

Roche Diagnostics Canada president and general manager Ian Parfrement said: "We will partner with healthcare professionals and authorities to redefine and adapt current practice guidelines to encourage clinicians to incorporate these new tests in their patient protocols.

"If caught early, cervical cancer is one of the most preventable and curable cancers with a survival rate of more than 90% and with our cervical cancer screening solution we will certainly improve patient care and people's health."

The cobas 4800 HPV test provides both pooled high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, which are responsible for about 70% of cervical cancer.

The approval of cobas 4800 HPV test is based on results from the landmark ATHENA trial, which enrolled more than 47,000 women.

The trial showed that one in four women who are HPV 16 positive will have cervical disease within three years and that nearly one in seven women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.

Results from the ATHENA trial also included a comparison of a cobas 4800 HPV Test screening strategy to alternative strategies using Pap cytology and HPV testing.