AltheaDx announces that they have successfully passed the State of California survey for CLIA (Clinical Laboratory Improvement Amendments) certification.

AltheaDx is offering high-quality patient and biopharma molecular testing services from their state-of-the-art, GMP, GLP, and now CLIA compliant facility located in the Sorrento Valley, San Diego.

"We are excited about the addition of clinical laboratory testing to the suite of services in our offering," said David Macdonald, CEO of AltheaDx. "We are now able to extend our success into later stage clinical trials and provide broader market access for our assays. Our CLIA certification is an important milestone in realizing our strategy of bringing theranostics into clinical use."

AltheaDx provides its customers with a full range of molecular biopharma services: from biomarker discovery, clinical studies, diagnostic translation, through to reporting clinical results. AltheaDx will immediately provide clinical genotyping services from their CLIA certified laboratory for the K-RAS gene, along with a menu of other high-value molecular tests.

K-RAS testing allows clinicians to screen patients for mutations in the K-RAS gene, which are found in 35-45% of metastatic colorectal cancer cases as well as a variety of other cancers including breast, lung, and ovarian. K-RAS mutations have been shown to be predictive of limited clinical response and poor prognosis. Data announced at last year’s ASCO conference has led to a need for colorectal cancer patients to be screened for mutations in the K-RAS gene in order to identify the most appropriate therapy. Patients carrying mutations in the K-RAS gene do not respond to a class of drugs known as EGFR inhibitors — such as Vectibix® and Erbitux®.

Source: AltheaDx