Clarient announced this week the commercial launch of its lung cancer test, Clarient Insight Dx Pulmotype, which it said aids physicians in guiding treatment for non-small cell lung cancer patients.
Clarient Insight Dx Pulmotype is a five-antibody immunohistochemistry test that can be used to aid in the histological distinction between adenocarcinoma and squamous cell carcinoma in NSCLC tumor specimens. NSCLC accounts for approximately 85 percent of the more than 200,000 lung cancer cases diagnosed each year, the company estimated.
"Pulmotype provides pathologists with a valuable new tool to help their oncologist clients understand which patients are eligible for a number of new therapies now available for the treatment of NSCLC," said Clarient CEO Ron Andrews in a statement. "Having the lung cancer sample in our hands at the beginning of the diagnostic process allows us to assist the pathologist and the oncologist throughout the patient care process by delivering information on additional molecular markers, such as EGFR mutation and KRAS."
According to Ken Bloom, Clarient's chief medical officer, using Pulmotype to correctly assess pathology can help doctors choose the right drug for their patients, such as Genentech's Avastin or Eli Lilly's Alimta.
Additionally, "the power to identify patients with adenocarcinomas in NSCLC also promotes finding patients that also harbor EGFR mutations, which have been shown to predict response to a number of tyrosine kinase inhibitors," Bloom said in a statement.
The company is hoping that the test's ability to assess histological differences in NSCLC, as well as to detect EGFR mutations, will differentiate it from competing lung cancer diagnostics. "Our goal is to be the first place a pathologist goes after diagnosing NSCLC. Having a primary diagnostic test like Pulmotype on our menu should help us capture a growing number of lung cancer tumor specimens for initial testing," Andrews said in a statement.
Pulmotype is the first commercial test launched following Clarient's acquisition of Applied Genomics in December [see PGx Reporter 12-23-2009]. One of the many drivers for the acquisition was that Clarient would gain a path to the EGFR lung cancer testing market through Pulmotype.
The test has been validated in more than 1,000 patients, and peer-reviewed study results were published in the August 2009 edition of Modern Pathology.