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Melanoma is not only a seasonal summer cancer.

The statistics are staggering. The American Cancer Society estimates more than 76,000 new melanomas will be diagnosed in the US alone this year. Melanoma rates have been rising for over 30 years with the culprit ranging from a thinning ozone layer to sun loving baby boomers now reaching the average melanoma age of 61.

As with breast cancer, self-exams are an effective method for early intervention described on the National Cancer Institute website. Once a mole or lesion is found to be suspicious, a visit to a dermatologist is warranted for a thorough evaluation. The diagnosis of a suspicious lesion is typically determined by a skin biopsy confirmed by a pathologist evaluation of the skin lesion. Treatment ranges from early stage melanomas, which are simply removed surgically, to a more advanced stage melanoma treatment which may include surgery, chemotherapy, radiation, a biological or targeted therapies.

Follow the patient to most effectively Market your Melanoma:
To understand how to position and market a novel melanoma diagnostic, you first need to understand the patient journey from diagnosis to treatment decisions... 

Melanoma is not only a seasonal summer cancer.

The statistics are staggering. The American Cancer Society estimates more than 76,000 new melanomas will be diagnosed in the US alone this year. Melanoma rates have been rising for over 30 years with the culprit ranging from a thinning ozone layer to sun loving baby boomers now reaching the average melanoma age of 61.

As with breast cancer, self-exams are an effective method for early intervention described on the National Cancer Institute website. Once a mole or lesion is found to be suspicious, a visit to a dermatologist is warranted for a thorough evaluation. The diagnosis of a suspicious lesion is typically determined by a skin biopsy confirmed by a pathologist evaluation of the skin lesion. Treatment ranges from early stage melanomas, which are simply removed surgically, to a more advanced stage melanoma treatment which may include surgery, chemotherapy, radiation, a biological or targeted therapies.

Follow the patient to most effectively Market your Melanoma:
To understand how to position and market a novel melanoma diagnostic, you first need to understand the patient journey from diagnosis to treatment decisions.

The present landscape of melanoma diagnostic tests include:

  • An H&E histology stain evaluation of a biopsy tissue sample or sentinel lymph node
  • An advanced staining method to specifically diagnose complex melanomas including:
    • Immunohistochemistry and Special Stain markers
    • Fluorescent In Situ markers
    • Comparative genomic hybridization

Market research conducted by Market Ready Rx, revealed the following ...

  1. H&E is the primary diagnostic tool for melanoma. Pathologists acknowledge diagnosing 80-90% of all cases with H&E as their sole diagnostic tool. For example an H&E can differentiate a Basal cell carcinoma and a Squamous cell carcinoma
  2. Approximately 10% of dermatology cases are equivocal, requiring additional advanced staining markers to differentiate the type of melanoma
  3. Approximately 5% of difficult cases are typically sent out for consult by hospital pathologists needing dermatopathology expertise.

Melanoma

Pathologists performing advanced stains typically begin with a primary panel of two to three biomarkers:

  • Most common: HMB45, MART1/MelanA and S100
  • Others specialty tests include: SOX10, P16, FISH or array CGH
"The majority of melanomas I see in my community practice certainly are straightforward and can be diagnosed with H&E alone. However there's a whole spectrum of melanoma which is where we rely on immunos." Community dermatopathologist

Following the introduction of genomics in the late 1990s, emphasis moved towards functional biological markers tying IHC performance to biological function. The most important diagnostic goal for dermatopathologists is the ability to differentiate a true melanoma from a borderline melanoma. Many methods are not able to differentiate effectively and our studies show the following gaps in Melanoma diagnostics.

Gaps Identified in Melanoma Diagnostics Include:

  • Tools for borderline cases of invasive melanoma
  • Ability to differentiate and confirming lentigo maligna
  • Ability to differentiate between a combined benign nevus and melanoma vs. combined lesion melanoma.
  • A definitive test for severely atypical lesions dysplastic, spitz nevi, blue nevi
  • A nuclear stain for benign vs. malignant melanoma

Emerging Diagnostics:
There are several diagnostics bridging this gap

  • Myriad's myPath™: 23 gene mutation test aimed at differentiating malignant melanoma from benign nevi.
  • Ventana's Melanoma Triple Cocktail: a mixture of anti-Melanosome (HMB45), anti-MART-1/melan A (A103), and anti-Tyrosinase (T311) mouse monoclonal antibodies used to aid in the identification of a true melanoma.

Additionally, labs and diagnostic companies are gaining sophistication in their approach to market entry. Prior to launch, consider evaluating both the standard of care test and the emerging technology to ensure your diagnostic retains the best of current practices.

Novel Personalized Diagnostics for Melanoma:
New treatments are driving the need for companion diagnostics including

  • Caris Molecular Intelligence™ for Solid Tumors profiles utilizes a variety of techniques including IHC, FISH/CISH, PCR and Next-Generation Sequencing to provide individualized treatment information
  • Companion diagnostic bRAF is used to identify patients with the melanoma mutation most likely to respond to of the following targeted therapeutics such as dabrafenib (Tafinlar®), trametinib (Mekinist™), and Vemurafenib (Zelboraf®.)
  • Myriad: myPath™ is a diagnostic test to effectively differentiate malignant melanoma from benign pigmented skin lesions

Top Questions to Ask Prior to Launch:
When creating a strategy and positioning for your melanoma diagnostic, consider the following questions:

  1. Does your melanoma diagnostic fill an unmet need not currently addressed?
  2. Does the test fall in a part of the diagnostic schema not currently addressed?
  3. Is the clinician diagnostic report logical, intuitive and actionable?
  4. Will your test provide clinical information to changes course of treatment?
  5. Does the diagnostic define a clear Positive and Negative predictive value?
  6. Have you cultivated key opinion leaders and a Scientific Advisory Board?
  7. Is the market size sufficient to support your commercial and production expenses ?
  8. Do you have publications supporting your clinical utility?
  9. Do you have a complete sales channel to both educate and sell the product?

If you answered yes to at least five of the above questions you are on your way to a robust commercial launch.

A thoughtful strategy, careful positioning, and clear understanding of current clinical needs will help formulate your success in the melanoma diagnostic market. For more information on how Market Ready Rx can support your commercial market entry, visit us at www.marketreadyrx.com.