By a News Reporter-Staff News Editor at Gene Therapy Weekly -- DermTech, a privately held biotechnology company developing and commercializing qPCR assays for skin samples collected non-invasively using adhesive patch methods, announced it has initiated commercial validation testing of its proprietary pigmented lesion assay. The Company recently completed the build-out of a commercial laboratory space on 11099 N. Torrey Pines Road, La Jolla, CA. The analytical and clinical validation studies are required for regulatory certification following CLIA (Clinical Laboratory Improvement Amendments) requirements. The CLIA federal regulatory standards require clinical laboratories to establish and document their performance specifications for laboratory-developed tests to ensure accurate and precise results prior to implementation of the test. The performance characteristics that must be established include accuracy, precision, reportable range, reference interval, analytical sensitivity, and analytical specificity. A recent Series B financing led by Jacobs Investment Company LLC will be partially used to complete these efforts (see also DermTech).
The validation studies are being conducted under an institutional review board-approved protocol in collaboration with Northwestern University and the University of Pittsburgh Medical Center (UPMC). "We are pleased to work with DermTech on this important and cutting edge technology," said Pedram Gerami, MD, the principal investigator at Northwestern University. Laura Ferris, MD, PhD, the principal investigator at UPMC, added: "Many of my colleagues are looking forward to seeing the potential of DermTech's novel technology and its ability to help us detect gene signatures consistent with melanoma."
The Company's proprietary assays can analyze multiple gene targets to assess their level of gene expression. Initially, the Company will offer a novel assay that identifies expression consistent with melanoma. DermTech's qPCR assay is compatible with the use of an adhesive-patch method to collect cells from pigmented lesions including melanomas, allowing for non-invasive sample collection. Melanoma, which is responsible for the majority of skin cancer fatalities, is the deadliest of all skin cancers. It is estimated that more than 135,000 new cases of melanoma will be diagnosed in the U.S. in 2013, with more than 61,000 being non-invasive (in situ) and more than 76,000 being invasive. The American Cancer Society projects that approximately 80% of the more than 12,000 skin cancer deaths in 2013 will be from melanoma. Because approximately 62% of melanomas and 45% of melanoma deaths occur prior to age 65, melanoma places significant burdens on the healthcare system well beyond Medicare.
"The preparation of our commercial lab space and the initiation of our validation testing represent key milestones of our commercialization strategy", said John Dobak, MD, Chief Executive Officer and President. About DermTech Headquartered in La Jolla, California, DermTech is focused on the development of proprietary qPCR assays for dermatology. DermTech's assays can be used with skin samples collected non-invasively via adhesive-patch methods. The RNA from these samples is isolated, amplified, and analyzed using molecular biology tools to determine genetic expression profiles for a range of dermatologic conditions. DermTech is actively pursuing the development of an assay that can assess gene expression consistent with melanoma. For additional information visit: www.dermtech.com.
Keywords for this news article include: DermTech, Genetics, Oncology, Melanomas, Technology, Cancer Gene Therapy, Government Agencies, Offices and Entities.
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