DermTech, Inc. (DMTK) - Get Report ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today that non-invasive genomic patch testing for melanoma, like DermTech's Pigmented Lesion Assay ("PLA"), has received a recommendation from the National Comprehensive Cancer Network ® ("NCCN"). The recommendation indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Clinical Practice Guidelines in Oncology (the "NCCN Guidelines®") for cutaneous melanoma recognize the use of noninvasive genomic patch testing to help guide biopsy decisions for cutaneous melanoma.
The NCCN Guidelines® are the recognized standard for clinical policy in cancer care and the most detailed clinical practice guidelines available in any area of medicine. The recommendation for pre-diagnostic non-invasive genomic patch testing can be found in the latest edition, NCCN Guidelines® Version 1.21, Melanoma: Cutaneous, section ME-11, Common Follow-Up Recommendations for All Patients. The updated guidance now states: "Pre-diagnostic noninvasive genomic patch testing may also be helpful to guide biopsy decisions."
As a not-for-profit alliance of 30 leading cancer centers, the core resources made available by the NCCN are the NCCN Guidelines®. These guidelines are decision tools created by leading clinicians to explain a disease and help determine the best way to treat a patient, depending on their diagnosis, disease stage and other factors, such as age. The NCCN Guidelines® also help doctors make decisions, by explaining the pros and cons of each option.
"I laud the NCCN for recognizing the value of non-invasive genomic patch testing and including it in the current guidelines. This non-invasive genomic patch testing is a revolutionary change in the assessment of lesions suspicious for melanoma. Many commercial payors rely on guidelines from organizations such as NCCN as benchmarks for coverage decisions, and this NCCN recommendation indicates there is consensus that recognizes the value of the noninvasive genomic patch testing to guide biopsy decisions," said Daniel M. Siegel, M.D., Clinical Professor of Dermatology at SUNY Downstate and former President of the American Academy of Dermatology. "We are thrilled that the NCCN Guidelines® recognize technology like DermTech's as helpful in guiding biopsy decisions and foster earlier melanoma detection," said Burkhard Jansen, M.D., chief medical officer of DermTech. "Using genomic information provides clinicians with data even expert eyes cannot see and benefits patients with skin lesions clinically suspicious for melanoma. This is a significant milestone for precision genomics, and further substantiates the utility of our DermTech melanoma test, the Pigmented Lesion Assay, or PLA."
Covering 97 percent of all cancers affecting patients in the United States and updated on a continual basis, the NCCN Guidelines® are developed through explicit review of evidence (clinical trials, existing treatment protocol, etc.) integrated with expert medical judgment and recommendations by panels that are made up of representatives from the 30 NCCN Member Institutions.
There are currently 73 NCCN Guidelines® available free-of-charge that cover cancer detection, prevention and risk reduction, work-up and diagnosis, treatment and supportive care issues. To download the latest NCCN Guidelines®, please visit: https://www.nccn.org/professionals/physician_gls/default.aspx
DermTech is the leading genomics company in dermatology and is creating a new category of medicine, precision dermatology, enabled by our non-invasive skin genomics platform. DermTech's mission is to transform dermatology with our non-invasive skin genomics platform, to democratize access to high quality dermatology care, and to improve the lives of millions. DermTech provides genomic analysis of skin samples collected non-invasively using an adhesive patch rather than a scalpel. DermTech markets and develops products that facilitate the early detection of skin cancers, and is developing products that assess inflammatory diseases and customize drug treatments. For additional information on DermTech, please visit DermTech's investor relations site at: www.DermTech.com.
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of DermTech may differ from its actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations with respect to: the performance, patient benefits, cost-effectiveness, commercialization and adoption of DermTech's products and the market opportunity therefor. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of DermTech and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against DermTech; (2) DermTech's ability to obtain additional funding to develop and market its products; (3) the existence or continued existence of favorable or unfavorable clinical guidelines for DermTech's tests; (4) the reimbursement of DermTech's tests by Medicare and private payors; (5) the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for DermTech's products; (6) DermTech's ability to grow, manage growth and retain its key employees; (7) changes in applicable laws or regulations; (8) the market adoption and demand for DermTech's products and services together with the possibility that DermTech may be adversely affected by other economic, business, and/or competitive factors; and (9) other risks and uncertainties included in (x) the "Risk Factors" section of the most recent Quarterly Report on Form 10Q filed by DermTech with the Securities and Exchange Commission (the "SEC"), and (y) other documents filed or to be filed by DermTech with the SEC. DermTech cautions that the foregoing list of factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. DermTech does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based .
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