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Dx Focus: LabMD to Distribute Mitomics' Prostate Test; Lab21's NSCLC Companion Dx Test


Mitomics said this week that it has signed a non-exclusive agreement with LabMD to market its Prostate Core Mitomic Test in the US.

LabMD, an Atlanta-based clinical pathology laboratory, will distribute the test to its urology customers for patients with suspected prostate cancer who have a negative initial biopsy outcome.

PCMT is a PCR-based mitochondrial DNA test that detects the presence of cancerous cells using previously obtained prostate biopsy tissue.

Mitomics said the test has sensitivity of 84 percent and can accurately rule out prostate cancer with a negative predictive value of 91 percent.

Lab21, a personalized medicine diagnostics firm based in Cambridge, UK, has launched an EML4-ALK companion diagnostic testing service for non-small cell lung cancer patients.

The service will offer PCR-based testing for translocations in the ALK gene associated with response to ALK inhibitor therapy.

Lab21 will perform the test in its accredited laboratories in Cambridge. The test adds to companion diagnostics that the company already offers for portfolio KRAS, EGFR, and BRAF mutation analysis.

Clinical trials have shown that NSCLC patients with translocations in the ALK gene have a better outcome when treated with an ALK inhibitor. Approximately 5 percent of NSCLC patients harbor an ALK translocation and more than 80 percent of those are with the EML4 gene, Lab21 said.

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