Myriad Genetics Rises From Depths on Melanoma Detection Test

Andrew Klips  |

Pulling itself up from 52-week lows, Myriad Genetics ($MYGN) posted a 4.8-percent climb on Monday after announcing that its myPath Melanoma test could tell the difference between malignant melanoma from benign skin lesions with regularity.  The results from a validation study were presented at the American Society of Dermatopathology Meeting on Sunday.

The Salt Lake City-based molecular diagnostic company said that the study evaluated a 23-gene panel and analyzed 464 skin biopsy samples, including 254 samples representing melanomas from all major subtypes, including superficial spreading, lentigo maligna melanoma, acral, nodular and desmoplastic lesions.

From the patient samples, the myPath Melanoma test demonstrated sensitivity of 89 percent and specificity of 93 percent at differentiating cancerous from non-cancerous skin lesions.

Melanoma is not as common as other skin cancers, but it is far more deadly if not caught at early stages, accounting for three-quarters of all skin cancer-related deaths.  The American Cancer Association reported that melanoma rates have been rising for at least three decades and that 76,690 cases will be diagnosed in 2013, leading to 9,480 deaths.  Late stage melanoma has a five-year survival rate of 15 percent, versus an early-stage rate of roughly 90 percent.

About two million skin biopsies are performed annually in the U.S., with about 280,000 of those biopsies classified as inconclusive, meaning the dermatopathologist can’t confidently determine whether the biopsies is cancerous or not.

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"The data from this large cohort showed that this test is highly accurate, relative to expert dermatopathologic review, at differentiating malignant melanoma from benign skin lesions," said Sancy Leachman, M.D., Ph.D, chair of the Department of Dermatology in the Oregon Health & Science University School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute.

Leachman also commented that today’s methods to diagnose melanoma are often subjective, rather than objective like the myPath test, potentially saving lives.

The news bodes well for Myriad, whose leading product is a BRACAnalysis test for breast and ovarian cancer.  BRCA1 and BRAC2 gene mutations are related to up to one-quarter of all hereditary breast and ovarian cancers, with diagnoses rates significantly increased in patients with the mutated genes.  Myriad has been under pressure recently, in part because of the U.S. Supreme Court delivering a mixed decision on the patentability of the company’s BRACAnalysis test.  Myriad has patent infringement lawsuits against Ambry and Gene By Gene, claiming that it spent more than a half a billion dollars developing the test and that it is incurring damages because of the rival’s tests that it says infringe on its protected technology.

When Myriad released its latest quarterly results, BRACAnalysis sales totaled $129.6 million, up 19 percent from the year prior quarter and representing nearly 75 percent of its total sales.  The company got a lift from actress Angelina Jolie creating publicity for its test with her decision for a voluntary double mastectomy because she was at a high risk to develop breast cancer because of a mutated gene.  Litigation costs and increased taxes are weighing on profits, leading to the company to forecast guidance below expectations.

Shares have fallen sharply from an intraday high of $38.27 in June, closing on Friday at $22.77 before gaining some traction to move ahead to $23.87 during Monday’s session.

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