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FDA Approves Expanded Use for Roche Cytology Test in Patients With Cervical Cancer

NEW YORK – Roche announced Wednesday that its CINtec Plus Cytology test received approval from the US Food and Drug Administration for expanded use in patients with human papillomavirus. 

The biomarker-based test can now be used as triage for patients with positive Cobas HPV tests and is more sensitive than traditional Pap cytology, according to the company. The test provides clinicians with more information about which patients "will benefit most from immediate follow-up," Roche said in a statement. The test received original FDA approval in March, and the company's Cobas HPV test received FDA approval in April. 

The test detects the simultaneous presence within a single cell of the p16 and Ki-67 biomarkers, which are associated with HPV infections that are transforming and could lead to cervical cancer. A positive test result signals that a patient is more significantly at risk for the disease, Roche said. The cytology test runs on the BenchMark Ultra IHC/HIS system and is performed with the same sample as used for HPV or Pap cytology tests.

"The biomarker information helps to clarify a woman’s risk of disease, reduce the potential for over- or undertreatment, and is a major step forward in individualizing a woman’s care,” said Roche Diagnostics CEO Thomas Schinecker.