RYE BROOK, NY--(Marketwire - April 6, 2012) - CBLPath announces today its implementation of a molecular assay using fluorescence in situ hybridization (FISH) to help in the diagnosis of melanoma. The least common but most aggressive form of skin cancer, melanoma is occurring at sharply increased rates, especially among young adults, as noted in a study released this week in the journal Mayo Clinic Proceedings.
Not widely available at present, the inventive melanoma FISH four-probe panel aids in the identification of ambiguous, or "borderline," skin lesions as malignant melanoma or benign nevi (moles). The test provides vital genetic information about individual patients by looking for specific chromosomal abnormalities in their melanocytes, the skin's pigment-producing cells. Primary melanomas are known to have a much higher rate of genetic anomalies as compared to benign nevi.
"It's truly rewarding that CBLPath is one of only a few laboratories offering this ground-breaking and timely test. While most melanomas can be diagnosed on a histological basis, this method opens a new diagnostic avenue for lesions with morphologic ambiguity, allowing for greater accuracy in differentiating malignant melanoma from nevi with and without atypia," said Chief Medical Officer, Dr. Carlos D. Urmacher, FCAP, FASCP.
"We're most proud of the direct and significant impact that this is having on patient care. The advanced four-probe protocol will no doubt save many lives over the course of time as new melanoma cases are clearly delineated, leading to prudent treatment decisions based on each patient-specific diagnostic finding."
CBLPath is in an industry-leading position due to the limited availability of the melanoma FISH test. In addition to its client base of practicing physicians, the company is offering the panel to dermatopathologists in physician's office laboratories (POLs), independent laboratories and laboratories with hospital affiliations.
Approval from the New York State Department of Health to offer the melanoma FISH panel came after CBLPath validated probes to examine specific loci (gene locations) on chromosome 6 -- namely RREB1, MYB and CEP 6 -- as well as locus CCND1 on chromosome 11. The test is run on formalin-fixed paraffin-embedded (FFPE) tissue specimens via fluorescence in situ hybridization, which employs genetic mapping using fluorescent tags to analyze genetic and chromosomal abnormalities.
In addition to skin lesions, the four-probe FISH diagnostic can be used in the evaluation of sentinel lymph nodes and other relevant clinical presentations.
The addition of the FISH melanoma panel enhances CBLPath's already strong Dermatopathology Program, which includes a full IHC menu for dermatopathology evaluation and complete FISH test menu for lymphoid and melanocytic lesions of the skin, complemented by molecular testing for T- and B-cell rearrangement and BRAF mutation analysis specific to melanoma as a companion diagnostic for Zelboraf®.
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.