Laboratory Corporation of America® Holdings has announced that it has entered into a license agreement with Veridex, LLC to commercialize nucleic acid testing technology for detecting the presence of a key tissue marker in prostate cancer, methylated GST-Pi.
LabCorp is the first full-service, national clinical laboratory in the U.S. to license this important new technology. Terms of the agreement were not disclosed.
Prostate cancer is the leading cause of cancer death in men in the U.S., with more than 230,000 cases diagnosed annually. Both genetic mutations and epigenetic abnormalities are known to contribute to the development and spread of prostate cancer.
DNA hypermethylation, a type of chemical modification of DNA that can be inherited without changing the DNA sequence, is the most common epigenetic abnormality in prostate cancer, playing a significant role by silencing the expression of key genes such as GST-Pi.
The assay LabCorp plans to offer is anticipated to be useful for biopsies with suspicious histopathology, and for patients who have elevated prostate specific antigen (PSA) values with biopsy findings that are repeatedly negative.
"We look forward to offering this exciting new technology to physicians and their patients," said Myla P. Lai-Goldman, M.D., Executive Vice President, Chief Scientific Officer and Medical Director for LabCorp. "A quantitative PCR assay specific for methylated GST-Pi will be a valuable diagnostic tool to help clinicians resolve difficult-to-diagnose prostate cases and reduce the anxiety many patients experience when the status of their condition is uncertain."