Roche (RHHBY) has a broad portfolio of diagnostic tests with more than a hundred high-quality Elecsys assays for immune testing along with a new generation of fully automated cobas analyzers for improved medical decision making, scheduling and efficiency.
The company is striving hard to further strengthen its Diagnostics division. Roche recently received positive news when Health Canada approved its cobas 800 HPV (Human Papillomavirus) Test for use as a first-line primary screening test for cervical cancer in women aged 25 years and above.
Additionally, Roche launched its fully automated CINtecPLUS test in Canada, which enables improved detection and early intervention of pre-cancerous cervical disease. The launch of the cytology test in Canada will help identify women with high-grade pre-cancerous cervical lesions who need immediate colposcopy.
Roche's cobas 4800 HPV Test will provide both pooled high-risk HPV DNA results and individual detection of HPV 16 and HPV 18, which cause approximately 70% of cervical cancer. The approval was based on encouraging results from the ATHENA trial wherein it was observed 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 suffered from high-grade cervical disease that was missed by cytology.
We remind investors that in Apr 2014, the FDA also approved Roche's cobas HPV Test for use as a first-line primary screening test for cervical cancer in women aged 25 years and above.
We are impressed by Roche’s efforts to strengthen its Diagnostic Division. The Diagnostics Division generated sales of $10.5 billion in 2013, up 4% from a year ago. The approval of new tests will further boost the sales of this division.