CBLPath Offers New FDA Approved, First-of-Kind ALK Molecular Test

New Companion Diagnostic Helps Identify Candidates for the Latest FDA Approved Non-Small Cell Lung Cancer Therapy


RYE BROOK, N.Y. — CBLPath announced today that it now provides the new anaplastic lymphoma kinase (ALK) companion diagnostic, which recently received approval from the U.S. Food and Drug Administration (FDA). The test aids physicians in making the best treatment decisions for patients with non-small cell lung cancer (NSCLC) who may be candidates for XALKORI®(crizotinib) targeted therapy.

CBLPath is offering the new Vysis® ALK Break Apart FISH Probe Kit through its affiliation with Abbott Molecular, Inc., which received FDA approval for its test concurrently with Pfizer, Inc., the maker of XALKORI — a targeted therapy approved for use in late-stage NSCLC in patients with ALK gene rearrangements.

Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with specific molecules involved in tumor growth and progression. Some 3–7% of all non-small cell lung cancer patients — typically non-smokers — have been found to have ALK gene rearrangements that may benefit from XALKORI targeted therapy.

The Vysis ALK Break Apart FISH Probe Kit test run by CBLPath identifies patients who are more likely to benefit from XALKORI therapy. Rearrangements of the ALK gene are examined via fluorescence in situ hybridization (FISH), which employs genetic mapping using fluorescent tags to analyze genetic and chromosomal abnormalities.

“Our laboratory is committed to providing these leading-edge tests as part of the growing trend in oncology toward companion diagnostics and targeted therapies, which can more effectively treat malignancies with fewer side effects than other drugs,” said CBLPath Chief Medical Officer Carlos D. Urmacher, M.D., FCAP, FASCP. “The recent concomitant approval by the FDA demonstrates the important role of companion diagnostics in providing the safest, most effective treatment for each patient and the growing role of personalized medicine in healthcare.”

Personalized medicine emphasizes the tailoring of healthcare decisions and practices to individual patients, often through the use of genetic information.

To speak with a CBLPath representative about ordering the new ALK test, call 877.225.7284. To see the company’s entire array of tests, visit www.CBLPath.com and click Test Menu.

For more information about the FDA’s approval of XALKORI and the ALK companion diagnostic, visit the News & Events section at www.fda.gov.

About CBLPath
CBLPath is a national specialty lab with a unique leadership position in the convergence of anatomic, molecular and digital pathology. Beginning from a clinical perspective, we harness molecular testing and digital pathology on an anatomic pathology foundation. CBLPath is committed to helping our clients deliver better medicine, faster. At our core are pathologists; excited about technology and innovation and its promise of helping patients. Through the Best Practice™ Partnership Program we help our pathologist-clients effectively compete against centralized reference laboratories, grow their Practice and remain independent — Keeping Medicine Local™. We provide our subspecialty physician clients comprehensive diagnostics and timely, accurate reports enabling the best patient care. For more about the company, please visit www.CBLPath.com.