Originally published Feb. 20.
By Turna Ray
Lab21, a UK-based clinical lab services and diagnostics company, has begun providing companion diagnostic testing to personalize treatments for non-small cell lung cancer patients.
Specifically, the company is providing testing services to help physicians determine which of their NSCLC patients harbor EML4-ALK translocations and therefore are more likely to respond to ALK inhibitors, such as Pfizer's Xalkori (crizotinib) and other drugs under development.
In the US, Xalkori was approved by the US Food and Drug Administration last year alongside Abbott's ALK mutation test, which runs on a fluorescence in situ hybridization-based platform. Although Xalkori is indicated only for NSCLC patients who are determined to be ALK-positive by an FDA-approved test, the drug's label doesn't mention Abbott's test by brand name. However, for the time being, Abbott has the only FDA-approved companion diagnostic in this setting.
The European Medicines Agency last year accepted Pfizer's application for marketing authorization for crizotinib, but has yet to issue a decision. According to the UK's New Drugs Online website, Pfizer has also registered for regulatory approval for crizotinib there, and the drug is slated for cost-effectiveness review by the National Institute for Health and Clinical Excellence in 2013.
A Lab21 spokesperson told PGx Reporter that the companion diagnostic the company is offering is a proprietary assay that uses quantitative RT-PCR to gauge EML4-ALK translocations. The company is not offering the test in the US, the spokesperson clarified.
There are approximately 1 million NSCLC patients worldwide and small subset of them, around 5 percent, have ALK translocations. The most common ALK translocations, more than 80 percent, occur with the EML4 gene.
"Clinical trials show that patients suffering from NSCLC with translocations in the ALK gene have a significantly improved outcome when treated with an ALK inhibitor," the company said in a statement.
Lab21 is hoping to drive broad use of its testing service with a number of ALK inhibitors, not just crizotinib. "The test could be used to stratify patient populations for any ALK inhibitor. There are a number in development," the spokesperson said.
The EML4-ALK translocation test expands Lab21's portfolio of diagnostic service offerings, which includes KRAS, EGFR, and BRAF mutation analysis. The company views the EML4-ALK service as complementary to its EGFR service, since both tests can help guide personalized treatment decisions for NSCLC patients.
The EML4-ALK translocation test allows "oncologists to tailor a patient’s treatment in order to achieve the best possible outcome and … this service will allow access to testing throughout the UK, Europe, and Middle East," Mike Annable, division director of Lab21's clinical laboratory division, said in a statement.
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