FierceBiotech

FDA approves new streamlined workflow option for Roche's cobas HPV Test

New process allows labs to use same Pap test vial instead of transferring sample to new vial, thus simplifying workflow INDIANAPOLIS, June 26, 2013 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) ...
The American Journal of Managed Care

Roche Molecular Diagnostic's cobas HPV Test Approved by the FDA

A test that can detect the DNA of the human papilloma virus (HPV), to confirm the need for cervical cancer screening in women 25 years and older, has gained the FDA’s support as a primary screening ...
Business Insider

Roche Granted WHO Prequalification For The Cobas HPV Test

(RTTNews) - Biopharmaceutical company Roche Holding AG (RHHBY), announced on Tuesday that its cobas HPV test for use on the cobas 6800/8800 Systems has been awarded the World Health Organization (WHO) ...
FierceBiotech

FDA approves Roche HPV test add-on for identifying women with higher risk of cervical cancer

The FDA approved Roche’s diagnostic for triaging women whose primary cervical cancer screenings have tested positive for the human papillomavirus (HPV). The company’s CINtec PLUS Cytology test is ...
CNN

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

More than 99 percent of cervical cancers are caused by persistent high-risk HPV infection 1 Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; ...
Becker's Hospital Review

FDA Committee: HPV Test Can Replace Pap Smear for Cancer Screening

The U.S. Food and Drug Administration’s Medical Devices Advisory Committee Microbiology Panel unanimously voted that Roche Molecular Systems’ cobas viral DNA test is safe and effective as a ...
DrBicuspid

FDA approves 1st HPV test for primary cervical cancer screening

The U.S. Food and Drug Administration (FDA) has approved a human papillomavirus (HPV) DNA test for women 25 and older that can be used to determine whether these women should have additional ...
Nasdaq

WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche’s role in pioneering ...

Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results Dual-stain biomarkers aid in ...
Seeking Alpha

Survey commissioned by Roche shows that HPV infection, which causes 99% of all cervical cancer cases, remains largely misunderstood by the general public

However, more than 70% of the respondents indicated they would be interested in the option of collecting their own sample for screening if available. The research also demonstrated that with screening ...
Pharmabiz

Roche introduces preanalytical device cobas p 480

Roche, the world's largest biotech company, has launched pre-analytical device cobas p 480 to uncover and summarize primary sample vials used in cytology-based in liquids (LBC) and molecular assays ...
GEN

Roche’s Cobas Test for Chlamydia and Gonorrhea Granted 510(k) Clearance in U.S.

Multiplex PCR Assay for cobas 4800 system uses self-collected male urine and vaginal swab samples. FDA granted 510(k) clearance for Roche’s cobas® CT/NG Test for detecting Chlamydia trachomatis (CT) ...
Nasdaq

Survey commissioned by Roche shows that HPV infection, which causes 99% of all cervical cancer cases, remains largely misunderstood by the general public

Survey findings from over 8,700 people in 12 countries show that half of those polled have inadequate understanding of HPV, with nearly one-third being unsure or unaware of it altogether.1 Findings ...