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HealthLinx Inks Deals for Prostate Cancer Biomarkers, Ovarian Cancer Dx

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – HealthLinx separately announced this month a collaboration with the Garvan Institute of Medical Research to assess HealthLinx's IP for prostate cancer, and the appointment of CPC Clinical Research to aid it in obtaining approval from US regulators for its ovarian cancer test.

In one deal announced today, the Australian biomarker-based diagnostic test development firm said that it and the Garvan Institute, based in Sydney, will conduct a study to evaluate the expression of HealthLinx biomarkers in plasma samples and its relationship with chemotherapy. The study will also assess the survival rates of patients with prostate cancer.

The Garvan Institute will provide plasma samples, both before and after treatment with chemotherapy drug docetaxel. HealthLinx will apply its proprietary assays to determine plasma concentrations of its biomarkers. The institute will then analyze the subsequent data.

The study will begin this month and results are expected in the third quarter, HealthLinx said.

Earlier this month, HealthLinx said it appointed CPC Clinical Research to help it in obtaining US Food and Drug Administration clearance for its OvPlex protein biomarker ovarian cancer diagnostic test.

CPC, based in Aurora, Colo., will help HealthLinx prepare a pre-IDE submission to the agency and coordinate meetings between HealthLinx and FDA.

"CPC will be fundamental in providing high-quality, independent services that will ensure the timely completion and validation of the OvPlex test," said Nick Gatsios, CEO of HealthLinx. "The partnership may also identify additional opportunities for HealthLinx to expand its business activities in the US."

OvPlex is currently available in Australia, the UK, and Singapore. HealthLinx is conducting a second study of the test involving 1,150 women to prove that it has a diagnostic accuracy of more than 97 percent for early stage ovarian cancer.

CPC is not-for-profit clinical research and community health organization offering Phase I to Phase IV clinical research services.

Financial and other terms of the two deals were not disclosed.

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