Rosetta Genomics Ltd. is a molecular diagnostics company with offices in Israel and the United States that uses micro-ribonucleic acid (microRNA) biomarkers to develop diagnostic tests designed to differentiate between various types of cancer

Cancer

Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...

. The company expects the first three tests based on its technology to be submitted for regulatory approval in 2008. The diagnostic tests will differentiate between squamous and non-squamous non-small cell lung cancer (NSCLC); differentiate between adenocarcinoma

Adenocarcinoma

Adenocarcinoma is a cancer of an epithelium that originates in glandular tissue. Epithelial tissue includes, but is not limited to, the surface layer of skin, glands and a variety of other tissue that lines the cavities and organs of the body. Epithelium can be derived embryologically from...

 and peritoneal mesothelioma

Peritoneal mesothelioma

Peritoneal mesothelioma is the name given to the cancer that attacks the lining of the abdomen. This type of cancer affects the lining that protects the contents of the abdomen and which also provides a lubricating fluid to enable the organs to move and work properly.The peritoneum is made of two...

; and seek to identify the origin of tumors in patients representing cancer of unknown primary (CUP). Using a single microRNA, the highly sensitive, highly specific test for squamous and non-squamous lung cancer has passed the prevalidation phase and has been submitted for approval to the New York State Department of Health Clinical Laboratory Evaluation Program in April 2008.

In April 2008, Nature Biotechnology

Nature Biotechnology

Nature Biotechnology is an academic journal covering the science and business of biotechnology.Nature Biotechnology is a continuation of Bio/Technology , which was founded in 1983 and renamed in 1996. It is published monthly by the Nature Publishing Group, a division of Macmillan Publishers Ltd...

published a study by Rosetta Genomics’ scientists whose findings demonstrate microRNAs' significant potential to act as effective biomarkers that may be applied in a diagnostic test designed to identify the primary tumor site in patients CUP. In addition to its diagnostic programs, Rosetta Genomics is collaborating with Isis Pharmaceuticals to develop a microRNA-based therapy for Hepatocellular carcinoma

Hepatocellular carcinoma

Hepatocellular carcinoma is the most common type of liver cancer. Most cases of HCC are secondary to either a viral hepatitide infection or cirrhosis .Compared to other cancers, HCC is quite a rare tumor in the United States...

 (HCC), a form of liver cancer

Liver cancer

Liver tumors or hepatic tumors are tumors or growths on or in the liver . Several distinct types of tumors can develop in the liver because the liver is made up of various cell types. These growths can be benign or malignant...

.

Intellectual property

Rosetta Genomics has developed a microRNA discovery process combining powerful informatics with high-throughput biological techniques. This has led to the discovery of a large portion of today’s known human and viral microRNAs.

In 2007, the U.S. Patent and Trademark Office issued Rosetta Genomics with two patents relating to microRNAs. In March 2008, Rosetta Genomics announced that the U.S. Patent and Trademark Office has issued allowance for two of the company's patent applications on human and viral microRNAs.

Platform technologies

Rosetta Genomics has developed several proprietary technologies that enable the Company to work with microRNAs. At the basis of these technologies are proprietary microRNA extraction protocols that include sensitive extraction of microRNAs from most body fluids, including serum, urine, saliva, with virtually no microRNA lost in the extraction process. The company has also developed a microRNA extraction protocol from Formalin Fixed Paraffin
Embedded, or FFPE, samples. This allows extraction of microRNAs from samples preserved at room temperature.

Once microRNAs are extracted, Rosetta Genomics’ technology is capable of detecting and quantifying the microRNAs using two custom designed platform technologies which utilize Quantitative Real Time PCR (or qRT-PCR) and microarrays.

The Company’s proprietary microarray platform covers approximately 850 human microRNAs, including approximately 180 microRNAs which are Rosetta Genomics’ proprietary microRNAs. The array’s high specificity allows discriminating homologous family members.

Licenses and collaborations

In January 2008, Rosetta Genomics announced a collaboration agreement with the Henry Ford Health System

Henry Ford Health System

The Henry Ford Health System is a comprehensive, integrated, non-profit, managed care, health care organization located in Southeast Michigan. The corporate office is in Detroit, Michigan...

 in Detroit, Michigan to develop microRNA-based diagnostics and prognostics for brain cancer. Also in January 2008, Rosetta Genomics announced that its subsidiary, Rosetta Genomics Inc. has received a license to use Roche Molecular Systems' PCR technology in microRNA-based diagnostic tests. In September 2007, Rosetta Genomics said it will work with New York University

New York University

New York University is a private, nonsectarian research university based in New York City. NYU's main campus is situated in the Greenwich Village section of Manhattan...

 Medical
Center to develop a microRNA-based diagnostic test for melanoma

Melanoma

Melanoma is a malignant tumor of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye...

.

In May 2007, Rosetta Genomics announced Columbia University Medical Center

Columbia University Medical Center

Columbia University Medical Center is an academic medical center that includes Columbia University's College of Physicians and Surgeons, College of Dental Medicine, School of Nursing and Mailman School of Public Health...

 would utilize its Clinical Laboratory Improvement Amendments

Clinical Laboratory Improvement Amendments

Clinical Laboratory Improvement Amendments of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.-CLIA Program:...

 (CLIA)-certified laboratory to perform the clinical validation of Rosetta Genomics’ diagnostics program for cancer of unknown primary.

In February 2006, Isis Pharmaceuticals Inc. and Rosetta Genomics said they will collaborate to develop antisense drugs that inhibit microRNA in the liver to treat cancers there. Antisense drugs are a class of compounds that interfere with genetic material that gets translated into harmful proteins.

History

Rosetta Genomics was founded by Isaac Bentwich in 2000 to pursue commercial applications of microRNA research. The company had its IPO on March 6, 2007 and is traded on the NASDAQ

NASDAQ

The NASDAQ Stock Market, also known as the NASDAQ, is an American stock exchange. "NASDAQ" originally stood for "National Association of Securities Dealers Automated Quotations". It is the second-largest stock exchange by market capitalization in the world, after the New York Stock Exchange. As of...

. Rosetta Genomics expects the funds raised to advance its microRNA-based diagnostic and therapeutic cancer products through initial clinical validation, defined as success in identifying the specific biomarker panels via blinded tests of samples supplied
by medical institutions.