Skin cancer awareness month puts spotlight on benefit of molecular diagnostics

“You have cancer.”

Those are powerful words that unfortunately far too many people have heard. Thanks to preventative screenings and medical advances, we are seeing a decline in deaths related to certain cancers. However, melanoma is not one of them and in fact; it is on the rise and has been over the last 40 years. As we recognize May as Skin Cancer Awareness Month, we must also recognize that according to the American Cancer Society, 9,480 people are expected to die of melanoma by the end of this year. That is unacceptable.

Every year as spring turns into summer, the public is inundated with tips on sunscreen use and sun exposure. We know that most of the mutations found in melanoma are from UV radiation. But what we didn’t know until we gained access to precision diagnostics is how to, with confidence born from near scientific certainty, match a person’s individual skin cancer to a specific therapy designed to eradicate it. This groundbreaking point in medical innovation has changed forever the conversations oncologists have with skin cancer patients and the decision-making around the course of their treatment. Taking into account that more advanced melanomas are often harder to treat because standard therapies such as chemotherapy are not very effective, molecular diagnostics and the art of personalized medicine have given new hope to those diagnosed with a too often lethal cancer.

Are we on the verge of outsmarting cancer? I would say innovative diagnostic technologies are hot on its trail. Just as our own individual DNA is unique, our bodies’ response to cancer is also unique, as are the therapies designed to treat it. There is no "one size fits all" course of treatment anymore. Precision diagnostics unlock the doors to clinically actionable data that provide a roadmap to the most effective medicines for each individual cancer patient.

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Consider metastatic melanoma. Prior to molecular diagnostics, treatment for this pernicious cancer was an abysmal failure. The identification of a particular molecular biomarker present in 50 percent of patients with metastatic melanoma turned the corner in treating the disease and when a particular therapy was approved by the FDA with the companion diagnostic test for the biomarker, the treatment success rate jumped to 50 percent, improving survival for half the population of patients previously looking at a bleak prognosis. This opened the door to a greater role for systems therapy and eliminated the very costly trial and error process physicians were forced to undergo when we simply did not have the information. Now patients do not have to endure repeat biopsies or the loss of precious time wasted while highly expensive therapies proved ineffective in treating their cancer. Molecular diagnostics allows physicians to get the treatment course right the first time.

Determining the value of a medical device, drug or test, considering the patient outcomes, cost effectiveness and contribution to society’s healthcare overall should be driving factors when developing policy around how the federal government reimburses healthcare services. In fact, eligibility to receive expensive targeted therapies is contingent upon the value of specific predictive molecular diagnostic tests and their impact on certain cancer patients. In his first major address as head of the agency, former Centers for Medicare and Medicaid Services (CMS) Administrator Don Berwick set forth in a 2008 speech the Triple Aim objective, which includes Better Care, Better Health and Lower Health Care Costs. Molecular diagnostics is one of the few discreet tools in healthcare that delivers on all three.

If labs conducting molecular diagnostic testing have to close or offer inferior testing due to Medicare reimbursement rates well below the cost of testing itself, pharmaceutical companies will have little incentive to continue research, development and bring to clinical trials cancer therapies with no “companion diagnostic.” Such a potentially dangerous domino effect could compromise innovation, tie the hands of the physician and turn a dream come true for the cancer patient into a nightmare.

In 2013, an estimated 76,690 new melanomas will be diagnosed in the United States, becoming the most common cancer among 25- to 29-year-olds and taking hold as the second most common cancer in 15- to 29-year-olds. That is also unacceptable.

Sir Francis Bacon is credited with the quote, “Knowledge is power.” We have the power to extend and in some cases, save lives with precision diagnostic testing that forges a path to the best care and the best health which in the end, is the cost effective option.


Randall A. Oyer, M.D. is the medical director of the oncology program for Lancaster General Hospital in Lancaster, Pa.