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Greiner Bio-One to Distribute Oncgnostics Cervical Cancer Test

NEW YORK (GenomeWeb) – Germany laboratory market distributor Greiner Bio-One has signed a marketing and distribution partnership with Oncgnostics to distribute its cervical cancer triage test GynTect, a molecular biology test that uses epigenetic biomarkers and methylation-specific PCR to determine whether an HPV-positive patient is at risk for developing cervical cancer.

Oncgnostics — a company spun off from the gynecology department of the Jena University women's hospital in Jena, Germany, in early 2012 — received a CE IVD mark for GynTect in October 2015. The company licensed methylation-specific PCR technology from MDxHealth in January 2015 in order to develop GynTect, allowing for "the accurate and sensitive assessment of DNA methylation markers … for the early detection of cervical neoplasias that may progress to cancer," Oncgnostics CEO Alfred Hansel said in a statement at the time.

Greiner Bio-One, which will start distributing the test in several European countries, also has an HPV test called the PapilloCheck. In a statement, the company said GynTect could add to PapilloCheck to form a sort of double diagnostic for HPV triage. "In fact, this is a classical win-win situation," Hansel added. "With GynTect, Greiner Bio-One strengthens its position in diagnostics, and we get the ideal partner for national and international distribution of our test. With its long-lasting presence and experience in the relevant diagnostic field Greiner will promote and establish GynTect within the right target group."

GynTect is now available for distribution in Germany, Austria, Switzerland, France, England, Belgium, the Netherlands and Luxembourg, Greiner Bio-One said. The company plans to expand to additional European countries as well as North America and Asia.