For the third time this fall, Utah's Myriad Genetics ($MYGN) is rolling out a new diagnostic product. This time, it's a melanoma skin biopsy test debuting first with a phased U.S. rollout and then in "key European markets" beginning in early 2014.
Myriad previously debuted its myPlan prognostic test in October for patients diagnosed with early-stage lung cancer. In early September, the myRisk Hereditary Cancer test, a diagnostic that screens for 25 different genes linked to breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and skin cancers, hit the market. And now there's myPath Melanoma, a new test with an average sticker price of about $1,500; the company's specialty sales force will promote the test to dermatopathologists.
Mark Capone, head of Myriad Genetic Laboratories, said in a statement that myPath is designed to address hard-to-diagnose cases in which "patients and physicians face the difficult question of whether to treat the lesion as melanoma or risk not treating a potentially fatal melanoma."
MyPath reaches the market following a successful study involving 464 skin biopsy samples and a validation study focused on 437 samples. Myriad released details from the first trial in October, and execs plan to release data from the second study at an upcoming medical meeting, Myriad spokesman Ronald Rogers told FierceDiagnostics.
A focus on melonoma is a smart one, considering that existing technology is often inconclusive. Myriad noted that 2 million skin biopsies are performed annually in a bid to diagnose melanoma, with 14% coming back as indeterminate, meaning a conclusive diagnosis either way isn't possible. The company said its verification study generated an accuracy rate of more than 90% in distinguishing between benign skin lesions and malignant melanoma.
Myriad has doubled down on product rollouts in the wake of a historic U.S. Supreme Court decision over the summer that ruled companies could not obtain a patent on human genes but could do so on cDNA, meaning genes tweaked in the lab. The ruling invalidated some Myriad patents but upheld others in a case involving BRCA1 and BRCA2 genes. Myriad's BRACAnalysis test was at the center of the case with its reliance on BRCA1 and BRCA2 genes to measure the risk for hereditary breast and ovarian cancer. A number of rivals launched competing tests in the wake of the decision, and Myriad hit the courts in response, an unsurprising move considering how the test has driven the bulk of Myriad's revenue until now. Myriad is now suing four competitors in the matter: Quest Diagnostics ($DGX), Bioreference Laboratories, Gene By Gene and Ambry Genetics.
Legal action aside, new test rollouts have been an important part of Myriad's growth strategy. The company's myPath test for melanoma builds on this.
As Myriad noted, melanoma is most the serious skin cancer, and more than 76,000 melanomas are diagnosed annually. Melanoma also kills 9,000 people each year. In other words, there is room for a more effective diagnostic player in the melanoma space.
- read the release