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Dx Focus: Roche CT/NG Test Gets FDA OK; Pinpoint Genomics and BioReference Labs Launch Cancer Assays


Roche said this week that its Cobas CT/NG test for Chlamydia trachomatis and Neisseria gonorrhoeae infections has received 510(k) clearance from the US Food and Drug Administration.

The multiplex PCR-based dual-probe assay runs on the Cobas 4800 platform and complements the Cobas HPV Test, which FDA cleared last year. Cobas CT/NG is designed to detect CT and NG infections in symptomatic and asymptomatic patients using urine in men and self-collected vaginal swabs in women. The test received the CE IVD mark in 2009.

Citing a report from the US Association of Public Health Laboratories and Centers for Disease Control and Prevention, Roche said that urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing. The specimen types are considered a progressive option for CT/NG screening because of high sensitivity. Additionally, they provide less invasive and less painful options to urethral or endocervical samples and may promote screening compliance, Roche said.

A trial for Cobas CT/NG confirmed that self-collected vaginal specimens and male urine specimens show increased sensitivity and specificity compared with other specimen types in populations with low and high disease prevalence, the company added.

Pinpoint Genomics this week announced the publication of key data in The Lancet relating to its Pinpoint Dx Lung assay, and said that the assay is now available to clinicians and patients through its laboratory in Mountain View, Calif.

Pinpoint's test is a 14-gene expression assay that uses quantitative PCR, runs on formalin-fixed paraffin-embedded tissue samples, and differentiates between patients at high, intermediate, or low risk of early death after surgery to remove a non-squamous, non-small cell lung cancer, the most common form of lung cancer.

The report in The Lancet describes the development of the assay based on specimens from 361 patients who underwent surgery at the University of California, San Francisco; as well as the results of the two largest independent, blinded studies to evaluate the clinical validity of the assay.

The two validation studies, conducted by the Kaiser Permanente Division of Research and the China Clinical Trials Consortium, involved 433 patients from northern California and 1,006 patients from several leading cancer centers in China, respectively. According to the results of the study, the assay improved prognostic accuracy beyond National Comprehensive Cancer Network criteria for stage I high-risk tumors, and differentiated low-risk, intermediate-risk, and high-risk patients within all disease stages.

BioReference Laboratories and its GenPath Oncology business unit last week announced the launch of OnkoMatch, the company's solid tumor genotype test.

OnkoMatch is specifically designed for solid tumor cancers such as lung, breast, colon, pancreas, thyroid and skin. Using DNA extraction and multiplex PCR-based mutational analysis techniques developed at Massachusetts General Hospital's Translational Research Laboratory, the test will analyze 14 oncogenes across 68 mutational hot spots from a single tissue specimen taken from a patient's tumor.

Tumor genotyping through OnkoMatch will enable oncologists to match their patients with appropriate targeted therapy, either FDA-approved or in a clinical trial setting, BioReference Laboratories said. Often patients with advanced disease are refractory to currently approved therapies and as a result, investigational therapies are sought to induce a tumor response. GenPath will share with the oncologist links to clinical trials associated with detected mutations allowing them to quickly access information needed to enroll patients in an appropriate trial.

BioReference and GenPath are offering the test through an exclusive commercialization agreement with Massachusetts General Hospital.