US-based molecular diagnostic firm Myriad Genetics has launched its Myriad myPath Melanoma, a new diagnostic test designed specifically for difficult to diagnose melanoma cases.
It will effectively differentiate malignant melanoma from benign pigmented skin lesions. Myriad myPath Melanoma is the third molecular diagnostic test launched by Myriad in fiscal 2013.
The new test has been extensively investigated in two independent clinical studies.
In the recently presented verification study results at the American Society of Dermatopathology annual meeting, the test demonstrated more than 90% accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes.
Results have recently been confirmed in an independent clinical validation study that will be presented at the American Academy of Dermatology's meeting in March 2014.
Malignant melanoma is an aggressive form of skin cancer, which is on the increase worldwide.
According to the American Cancer Society statistics, approximately 76,000 new melanomas are diagnosed each year and more than 9,000 people will die of metastatic disease annually.
In the US, there are approximately two million skin biopsies performed specifically for the diagnosis of melanoma every year.
According to the company, the new test plays a vital role in accurately differentiating malignant melanoma from benign skin lesions, reducing approximately 14% or 280,000 indeterminate biopsies annually.
Myriad Genetic Laboratories president Mark C Capone said even with years of clinical experience, pathologists still have cases where a definitive diagnosis is uncertain.
"In these cases, patients and physicians face the difficult question of whether to treat the lesion as melanoma or risk not treating a potentially fatal cancer.
"Myriad myPath Melanoma is designed for these difficult-to-diagnose cases and will provide healthcare providers with objective data that will improve the diagnosis of patients with suspicious skin lesions."
The test is currently being launched in a phases, beginning with an early access programme that will introduce the test to leading dermatopathologists across the country.
myPath Melanoma will be marketed through a dedicated specialty sales force from Myriad and has average selling price of $1,500.
In September, the company launched Myriad myRisk hereditary cancer, a new multi-gene diagnostic test for eight major hereditary cancers including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
Then in October, the company introduced Myriad myPlan lung cancer, a new prognostic test for patients diagnosed with early-stage lung cancer.
According to GlobalData estimates, the US tumour markers market was valued at $489m in 2012 and is expected to grow at a CAGR of 6.6% to reach $765m by 2019.