Navigation Links
DermTech's Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
Date:11/15/2011

LA JOLLA, Calif., Nov. 15, 2011 /PRNewswire/ -- DermTech, a biotechnology company developing non-invasive molecular diagnostics for disease detection, announced  it will present results from a study showing that its novel melanoma biomarker can be used with a high-throughput, low-cost qRT-PCR platform.  Strong earlier results using microarrays have been recapitulated on a qRT-PCR system that successfully discriminated melanoma with 100% sensitivity and 85% specificity.  Data will be reported at an oral presentation and during a poster session on November 17 at the Association for Molecular Pathology 2011 annual meeting in Grapevine, Texas.

DermTech's MelDTect™ melanoma detection test is based on the Epidermal Genetic Information Retrieval (EGIR®) approach that employs a patented adhesive-based method to obtain cells from the upper layer of the skin and genetic analysis to determine the probability of disease.  

"We saw exciting results using microarrays in our discovery work (Wachsman et al., British Journal of Dermatology, April 2011) and are pleased to report that our breakthrough approach to detecting melanoma is on course for clinical validation," said Sherman Chang, PhD, Senior Director of Molecular Biology. "Thus far in terms of accuracy, these data are better than any known detection product or products in development."

The study to be presented evaluated the suitability of a potential gene expression analysis platform along key parameters, including sensitivity, reproducibility, cost, linear dynamic range and throughput.  Using a qRT-PCR platform, it has been shown that the assays exhibited > 5-log linear dynamic range (LDR) and had a coefficient of variation (CV) < 3%.  Furthermore, 118 EGIR specimens (57 in situ and invasive melanomas, 61 nevi) were analyzed, and the 15-gene classifier was found to have an ROC AUC > 0.912 for discrimination of melanoma from nevi.

"The results, especially with respect to linear dynamic range, far exceed anything we've seen using microarrays and suggest that the non-invasive assay will perform extremely well in a high-volume clinical setting," said Bill Wachsman, MD, PhD, VA San Diego and UCSD, and a member of DermTech's Scientific Advisory Board.  "Since melanoma is highly curable if caught early, the goal is to develop a test that is highly sensitive, objective, and cost effective.  This assay meets these criteria and should be readily adopted."

DermTech's pre-validation study is expected to begin enrollment at clinical sites in Europe in early Q2 2012.  The study will evaluate use of the MelDTect test on a high throughput qRT-PCR platform in a broader population.

About DermTech:

Headquartered in La Jolla, California, DermTech is focused on the development of the company's patented Epidermal Genetic Information Retrieval (EGIR) technology.  The EGIR technology uses a custom adhesive tape to non-invasively and easily collect cells from the stratum corneum, i.e., the upper layer of the skin. The RNA from these cells is then isolated, amplified and analyzed using molecular biology tools to determine genetic profiles to be used for a range of applications including: non-invasive disease detection, personalized medicine and pharmaceutical R&D.  DermTech is actively pursuing research in the areas of melanoma, prostate cancer and other diseases and a number of skin conditions.  For additional information visit: www.dermtech.com.

About Melanoma:

Since 1930, there has been a 2000 times increase in the lifetime risk of developing melanoma.  By 2010, current estimates indicate 1 out of 50 people will be diagnosed with melanoma during their lifetime. (1)   Melanoma is the most common cancer in women aged 25-29.  5% to 10% of cases of cutaneous melanoma are the result of hereditary genetics in first-degree relatives. (2)   Unlike most other cancers, melanoma only infrequently responds to treatment and those available are highly toxic, impact quality of life.(3) If melanoma is treated before it spreads, it is 99% curable. (4)    The ten-year survival rate for melanoma patients whose disease is detected and treated at the earliest stages is 95-99% but drops to less then 5% if for a Stage 4 melanoma (invasive).(5)

  1. CA Cancer J Clin 2008
  2. Karolinska Institute, Aug 2008
  3. NCI Melanoma Treatment Options
  4. AAD Fact Sheet 2007
  5. American Joint Committee on Cancer – AJCC.  

Contacts:

DermTech
Jennifer Larson
415.725.2017
jlarson@dermtech.com


'/>"/>
SOURCE DermTech
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Auxogyn Licenses Non-invasive Embryo Assessment Technology From Stanford University
2. Dr. Suresh Koneru Introduces Zeltiq Non-Invasive Procedure For Fat Reduction
3. Doctors in New Hampshire Now Treating Cancer with Non-Invasive Image-Guided Radiosurgery Using Novalis Tx(TM) Technology
4. FDA Approves Label Change for Non-Invasive Fibroid Treatment
5. Non-Invasive Radiosurgery with Novalis Tx(TM) Platform Rolling Out Worldwide
6. Jennerex Reports Positive Mechanistic Proof-of-Concept Clinical Trial Results Using JX-594 to Treat Metastatic Melanoma
7. Morphotek®, Inc. Announces Initiation of MORAb-004 Phase II Study in Melanoma
8. Arthritis drug could help beat melanoma skin cancer
9. Melanoma transcriptome reveals novel genomic alterations not seen before
10. U.S. Food and Drug Administration Issues Complete Response Letter Regarding PEGINTRON(R) for Malignant Melanoma
11. Oncolytics Biotech(R) Inc. Announces Reovirus and Cisplatin Research Supports U.S. Phase 2 Metastatic Melanoma Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... June 27, 2016  Liquid Biotech ... funding of a Sponsored Research Agreement with The ... cells (CTCs) from cancer patients.  The funding will ... levels correlate with clinical outcomes in cancer patients ... will then be employed to support the design ...
(Date:6/24/2016)... ... 2016 , ... While the majority of commercial spectrophotometers and fluorometers use the ... models are higher end machines that use the more unconventional z-dimension of 20mm. ... the bottom of the cuvette holder. , FireflySci has developed several Agilent flow ...
(Date:6/23/2016)... , June 23, 2016   Boston ... of novel compounds designed to target cancer stemness ... has been granted Orphan Drug Designation from the ... treatment of gastric cancer, including gastroesophageal junction (GEJ) ... inhibitor designed to inhibit cancer stemness pathways by ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... YM (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. ... microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory and ...
Breaking Biology Technology:
(Date:6/7/2016)... , June 7, 2016  Syngrafii Inc. and ... business relationship that includes integrating Syngrafii,s patented LongPen™ ... project. This collaboration will result in greater convenience ... credit union, while maintaining existing document workflow and ... ...
(Date:6/2/2016)... -- The Department of Transport Management (DOTM) of ... US Dollar project, for the , Supply and ... and IT Infrastructure , to Decatur ... of Identity Management Solutions. Numerous renowned international vendors participated in ... was selected for the most compliant and innovative solution. ...
(Date:6/2/2016)... Perimeter Surveillance & Detection Systems, Biometrics & ... & Other Service  The latest report from ... of the global Border Security market . Visiongain ... billion in 2016. Now: In November 2015 ... and hardware technologies for advanced video surveillance. ...
Breaking Biology News(10 mins):