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MDx/CDx Focus: Pathway Launches Colon Cancer NGS Test; Prolaris Predicts Post-Prostatectomy Risk


Pathway Launches Hereditary Colorectal Cancer DNA Insight Test

Pathway Genomics announced the launch of its Hereditary Colorectal Cancer DNA Insight test this week.

The next-generation sequencing-based test analyzes a saliva sample and identifies genomic alterations that increase patients' risk of developing familial colorectal cancer, as well as their risk for other types of cancers. For example, the test gauges patients' risk for Lynch syndrome, familial adenomatous polyposis, Li-Fraumeni syndrome, juvenile polyposis, MUTYH-associated polyposis, Peutz-Jeghers syndrome, hereditary diffuse gastric cancer, and PTEN-hamartoma tumor syndrome.

According to the American Cancer Society, last year in the US there were 140,000 people diagnosed with colorectal cancer, and the disease has a high cancer mortality rate. Those with a first-degree relative with colon cancer, however, have a two to three times greater risk of developing the disease than those without a family history of the cancer.

Through its Familial Studies Program, Pathway will also provide free genetic testing to relatives of patients who harbor variants of unknown significance, which are mutations with uncertain links to cancer.

Myriad Publishes Another Paper on Prolaris

Myriad Genetics has published another paper in the Journal of Urology showing that its 46-gene expression test Prolaris was able to predict which patients would develop biochemical recurrence or metastatic disease after having a radical prostatectomy.

According to Myriad, Prolaris to date has been studied in 11 clinical studies involving 5,000 prostate cancer patients. The latest study, led by Jay Bishoff, director of Intermountain Urological Institute, helps inform the use of Prolaris in patients who have received radical prostatectomy, since 30 percent of patients in this subset still experience biochemical recurrence or metastatic disease after surgery.

The nearly 600-patient study assessed biopsy specimens from three cohorts of men who had had radical prostatectomy and were treated at the Martini Clinic in Hamburg, Germany, Durham VA Medical Center, and Intermountain Healthcare. In all the cohorts, the Prolaris score statistically significantly predicted the patients who would experience biochemical recurrence, and the test score was the best predictor of disease metastases compared to Gleason Scores or prostate-specific antigen scores.

Researchers reported in the paper that each one-unit uptick in the Prolaris score translated to a five-fold increase in patients' risk of metastases and a 1.6 times increase in biochemical recurrence risk.

The Prolaris score "derived from a biopsy sample was associated with adverse outcome after surgery," Bishoff and colleagues concluded in the paper. "These results indicate that the [Prolaris] score can be used at disease diagnosis to better define patient prognosis and enable more appropriate clinical care."