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Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

Written by Customer Service on . Posted in Public Companies.

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatmentNew indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programsMore sensitive than traditional Pap cytology, this test allows clinicians to determine which HPV-positive women require further diagnostic procedures to prevent disease progressionBasel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec® PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtec PLUS Cytology to triage positive results from the cobas® HPV Test run on the fully integrated, automated and high-throughput cobas® 6800/8800 Systems.
Attachment16092020_MR_FDA approval-EXUse_CINtec PLUS Cytology test

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