By Allison Proffitt
November 13, 2013 | Myriad Genetics got their fair share of press this summer when the Supreme Court ruled that Myriad’s gene patents were invalid. But in the past three months, the company has released three diagnostic and prognostic tests. Patent or no patent, they’ve been busy.
In the latest addition to their flurry of activity, this week Myriad launched myPath Melanoma, a diagnostic test meant to effectively differentiate malignant melanoma from benign pigmented skin lesions.
“What our test does, is accurately differentiates malignant melanoma from benign skin lesions and provides results for the physician that they can act upon,” says Ron Rogers, EVP of corporate communications for Myriad. “As you can imagine, if you were a patient and you had a skin liaison, they took a biopsy, sent it to a pathologist and the pathologist came back and said, well, we’re not really sure what it is, that’s an unsatisfactory result. With MyPath Melanoma, which is specifically designed for those difficult to diagnose cases, it will provide the healthcare providers with the data they need to diagnose patients.”
The test is being released in a phased approach beginning with an early-access program called The melEval Program that will introduce the test to leading dermatopathologists across the country. myPath Melanoma will be sold through a dedicated specialty sales force from Myriad and has average selling price of $1,500.
In September, the company released the myRisk Hereditary Cancer, a multi-gene diagnostic test analyzing 25 genes associated with eight major cancers including: breast (BRCA1 and BRCA2), colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
“The real important thing with myRisk [is that] it has much greater sensitivity to pick up mutations that we weren’t able to do previously because we are going from testing two genes to 25 genes, and 2 cancers (breast and ovarian) to eight cancers,” says Rogers.
The panel genes are all validated and clinically actionable, Rogers says, in part supported by Myriad’s proprietary variant analysis system. “These are all genes that are associated with cancer and you can take some clinical action to mitigate the risk,” he says.
But why test for eight cancers if you only have a family history for one? “We’ve presented data that there’s significant overlap between hereditary cancer syndromes, between hereditary breast and ovarian cancer and hereditary colon cancer and Lynch syndrome,” Rogers says. “That’s important because of the overlap. If you were just to get tested for breast cancer, you might not find a mutation that’s more associated with colon cancer, but also confers a risk for breast as well. You may miss patients if you just tested for breast and not for colon and vice versa.”
Myriad is banking on patients choosing, “a certain peace of mind” that comes with having risk data for eight cancers as opposed to two. myRisk is the same price—average selling price of $3,700—as the test for BRAC analysis. “You’re going to get a lot more information for the same amount of money.”
Finally, in October, Myriad announced a new prognostic test—Myriad myPlan Lung Cancer—for patients diagnosed with early-stage lung adenocarcinoma. Like the company’s Polaris prognostic test for prostate cancer, released about a year ago, myPlan Lung Cancer is an RNA expression panel of 31 cell-cycle-progression genes. Used in combination with tumor staging information, the test predicts a patient's risk of dying from lung cancer within five years.
Myriad reports that the myPlan Lung Cancer test has been studied in more than 1,500 patients, and has been shown to be significantly predictive of five-year lung cancer mortality and considerably more predictive than tumor staging information alone. In a validation study, patients with a high-risk myPlan Lung Cancer score had nearly twice the rate of lung cancer deaths (35%) than patients with a low-risk score (18%). These findings build on data published in Clinical Cancer Research that showed the myPlan Lung Cancer test is the strongest independent predictor of survival in patients with early-stage lung cancer as compared to the conventional clinical variables of disease progression including age, stage of disease, gender, smoking status and tumor size.
Myriad myPlan Lung Cancer is being launched in a phased approach beginning with an early-access, clinical-experience program to medical and scientific thought leaders, followed by a full commercial launch in calendar year 2014. myPlan Lung Cancer will be sold through Myriad's own specialty sales force to assist physicians in providing their lung cancer patients with the most appropriate healthcare management. myPlan Lung Cancer has a list price of $3,400.
The spate of tests is indicative of the company’s overall growth, says Rogers. “We think we have a full molecular companion diagnostics pipeline. We think we have the best pipeline in the diagnostics industry right now.”
Rogers believes that Myriad is unique in the molecular diagnostics industry because the company has expertise in DNA research, RNA analysis, and protein biomarkers. Other companies have expertise in one or two areas, he says, but Myriad has expertise in all three.
The company also has a strong roster of pharma partnerships. The company has ongoing public collaborations with AstraZeneca, AbbVie, Cephalon, BioMarin, Tesaro, and PharmaMar all around companion diagnostics for PARP inhibitors, and Rogers says there are other partnerships to develop companion diagnostic tests for drugs under development as well.