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MDx/CDx Focus: Myriad Launches MyPlan Lung Cancer Test; NY DOH Grants Permit for Pathway Fit; and More


Myriad Launches MyPlan Lung Cancer to Early Access Customers

Myriad Genetics this week launched its myPlan Lung Cancer test to a group of early-access doctors and thought leaders.

List priced at $3,400, Myriad plans to broadly launch the multi-gene expression panel on the market sometime next year.

The company said in a statement announcing the test launch that its own specialty sales force will market myPlan Lung Cancer to early-access customers. The test, developed by Myriad, gauges 31 cell cycle proliferation genes and 15 housekeeper genes and yields a score that delineates the risk that a patient with a Stage I/II lung adenocarcinoma will die within five years after surgical resection of their tumor.

Myriad highlighted that the test has been studied in 1,500 patients so far. Researchers from Myriad, MD Anderson Cancer Center, and elsewhere published a validation study in Clinical Cancer Research that showed that the myPlan score was the strongest predictor of cancer survival in early-stage lung cancer patients compared to conventional factors such as age, stage of disease, gender, smoking status and tumor size.

Separately, the company recently presented data from another study at a major medical conference showing that when researchers used the myPlan test, they predicted five-year lung cancer mortality with more accuracy than when they used tumor staging alone. After an early-stage lung cancer patient receives surgery, doctors primarily make treatment decisions based on tumor staging, which is a variable prognostic method and hasn't significantly reduced mortality rates.

MyPlan Lung Cancer is the second product launch for Myriad in the past two months. In early September, Myriad launched its MyRisk next-generation sequencing based hereditary cancer panel to 250 early access customers. MyRisk Hereditary Cancer gauges gene alterations for eight hereditary cancers, including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.

The company is also planning to launch the myPath Melanoma test soon, which Myriad plans to market as a molecular test that can differentiate between malignant and benign skin tissue. In mid-October, the company announced the results of a verification study involving more than 450 skin biopsy samples showing that the 23-gene panel had a sensitivity of 89 percent and a specificity of 93 percent.

Pathway Genomics Receives NY Clinical Lab Permit for its Fit Test

The New York State Department of Health has granted Pathway Genomics a clinical laboratory permit that will allow the company to market its Pathway Fit test to state residents.

The Pathway Fit test gauges genes involved in how people's bodies metabolize food and react to exercise. Based on the test results, Pathway provides recommendations to its customers about how they should tailor their exercise and nutrition in order to maintain "a healthy weight." The company is marketing the genetic test as a motivational tool to inspire life style changes among overweight or obese people.

Based on estimates by the Centers for Disease Control and Prevention, 60 percent of adults in New York are overweight and 24 percent are obese. According to NY DOH statistics, one-third of school-aged children in the state, with the exception of New York City, are overweight or obese.

Pathway analyzes genetic tests results in its CAP-accredited, CLIA certified lab in San Diego, Calif.

Labcorp to Offer Qiagen's FDA-Approved KRAS Companion Dx for Erbitux

Laboratory Corporation of America, one of the largest laboratory service providers in the US, said it will offer Qiagen's Therascreen KRAS RGQ PCR Kit.

The US Food and Drug Administration approved the KRAS test as a companion diagnostic that doctors can use to determine whether colorectal cancer patients have a normal KRAS gene and therefore have a better chance of responding to Bristol-Myers Squibb/Lilly's Erbitux (cetuximab).

LabCorp will sell Qiagen's test under the following name: KRAS Gene Mutation Analysis, Colorectal Cancer. The majority of the more than 100,000 US patients who develop advanced colorectal cancer each year have the wild-type or normal form of the KRAS gene, and therefore would likely benefit from Erbitux treatment.