A Medical Device Daily

Rosetta Genomics (Rehovot, Israel) reported presenting multiple posters at this week's annual American Association of Cancer Research (AACR; Philadelphia) conference in San Diego.

The posters include data on Rosetta's microRNA-based technologies and how they may be applied to develop diagnostic tests and therapeutics for cancer. They include:

"A microRNA-based diagnostic assay for non-small cell lung cancer." Rosetta has shown that a single microRNA can differentiate squamous from non-squamous NSCLC with high sensitivity and specificity.

"Identification of tumor origin using microRNA signature." Each year about 70,000 patients in the U.S. are diagnosed with cancer of unknown primary. Accurately identifying the origin of a metastasis can be critical in guiding treatment decisions. Rosetta has designed a classifier which assigns a primary site to a cancer sample based on the microRNA expression in the sample.

"Antisense oligonucleotides against microRNA as a novel therapy for hepatocellular carcinoma." MicroRNAs' regulatory role makes them attractive potential targets for therapeutics, through either their activation or suppression. Rosetta, in collaboration with Isis Pharmaceuticals (Carlsbad, California), aims to identify microRNAs that are deregulated in hepatocellular carcinoma and inhibit their activity through the use of antisense oligos.

"MicroRNA profiles in body fluids as a novel class of biomarkers." Rosetta has developed a platform for extracting and profiling of microRNAs from body fluids. The protocol was successfully applied to all body fluids and cell-free fluids examined, including serum, urine, saliva, amniotic fluid and pleural fluid.

Also at the AACR meeting: DermTech (La Jolla, California), a company developing molecular diagnostics for the early detection of melanoma and other diseases, presented data on its non-invasive assay that distinguishes melanoma from benign moles. The study, titled "A Non-invasive Genomic Assay for the Detection of Melanoma in Suspicious Pigmented Nevi," shows that the assay has 100% sensitivity and 90.6% specificity.

The biomarker based on 20 target genes is being developed as part of the company's proprietary molecular-based approach that uses the company's EGIR (Epidermal Genetic Information Retrieval) technology to identify melanoma at the earliest stages of disease.

DermTech's tape stripping method is based on applying a custom adhesive strip to the skin's surface to obtain RNA and subsequently using gene expression profiling techniques to identify disease.

"Results of this study suggest that the malignant melanocyte, directly or indirectly, induces an alteration in stratum corneum gene expression," said Sherman Chang, PhD, director of molecular biology at DermTech. "These findings pave the way for the development of an objective assay based on genomic data — a major advance over today's subjective method of identifying disease."