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QDx Pathology to Market Mitomics' PCR-Based Mitochondrial DNA Prostate Cancer Test in US

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Canadian molecular diagnostics firm Mitomics said today that it has entered into a non-exclusive licensing agreement with QDx Pathology to develop, market, and process a mitochondrial DNA test for determining the presence of malignant cells in normal-appearing prostate biopsies.

The test, which QDx Pathology will market under the name QPredict Prostate Mitomic Test, is based on Mitomics' currently marketed Prostate Core Mitomic Test, or PCMT.

QDx, based in Cranford, NJ, is a national, independent, CLIA-certified clinical and anatomical pathology laboratory. Under the agreement with Mitomics, QDx will "leverage its existing network of urologists, pathologists, and processing centers to expand the availability of the technology" in the US, Mitomics said in a statement.

Mitomics' laboratory-developed test uses quantitative PCR to detect changes in mitochondrial DNA in formalin-fixed, paraffin-embedded biopsy samples.

Large-scale deletions in mitochondrial DNA can indicate cellular changes indicative of the development of prostate cancer; and can be detected in otherwise normal-appearing tissue that may have surrounded a malignancy, a concept known as the cancerization field effect.

The test is designed for physicians to administer to patients who had a negative biopsy but who still appear to display common symptoms associated with prostate cancer.

Recent research from the company, published in January in Prostate Cancer and Prostatic Diseases, demonstrated that PCMT had a sensitivity of 84 percent and could accurately rule out prostate cancer with a negative predictive value of 91 percent.

"We believe the Mitomic technology is an important piece of the puzzle in detecting prostate cancer in patients with initial negative biopsies," M.N. Qureshi, president and medical director of QDx Pathology, said in a statement. "Using existing prostate biopsy tissue, the test negates the need for an additional biopsy procedure and can be performed quickly with rapid turnaround time. We believe that facilitating the early detection of low-volume prostate cancer should, in turn, lead to more definitive treatment."

Financial terms of the agreement were not disclosed.

Mitomics' PCMT test is also currently available to physicians in the US through Mitomics' CLIA lab in Aurora, Colo.

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