CBLPath Receives Approval from New York State Department of Health for XALKORI® Companion Diagnostic

Only FDA approved FISH test for NSCLC


RYE BROOK, N.Y. — Today, CBLPath announces it is one of a select few labs within the United States to offer Vysis® ALK Break Apart fluorescence in situ hybridization (FISH) testing for non-small cell lung carcinoma (NSCLC). The Vysis ALK FISH test detects rearrangements in the ALK gene employing fluorescent probes to detect the presence or absence of specific DNA sequences.

Vysis ALK FISH is the only FDA-approved companion diagnostic for XALKORI® (crizotinib). XALKORI was recently approved under the FDA’s priority review program for treatment of patients with late-stage NSCLC who have an abnormal ALK gene. XALKORI has been shown to inhibit the proliferation of ALK, thereby suppressing growth of NSCLC tumors.

“CBLPath is proud of the positive impact our work has on patients’ lives,” said Chief Medical Officer, Dr. Carlos D. Urmacher, FCAP, FASCP. “Keeping at the forefront of the latest technologies ensures our clients and their patients have access to the best therapies available. By receiving approval from New York State to run the Vysis ALK FISH test, we are able to help clinicians identify those patients who will benefit from treatment with XALKORI.”

Non-small cell lung cancer is the most common type of lung cancer with approximately 170,000 new cases per year in the United States. Non-small cell lung cancer includes adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. There are a variety of treatment options for NSCLC, and a patient’s success with any treatment option is dependent upon their genetic profile. About 1–7% of patients with NSCLC possess the ALK gene abnormality. These patients are typically young and non-smokers. Patients with the ALK mutation respond favorably to treatment with XALKORI.

XALKORI is a registered trademark of Pfizer Inc.
Vysis is a registered trademark of Abbott Laboratories

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.