Rosetta Genomics

Rosetta Genomics
Public (NASDAQ: ROSG)
Industry Biotechnology
Founded 2000
Founder Dr. Isaac Bentwich
Headquarters Rehovot, Israel and Jersey City, U.S.
Key people

Ken Berlin (President and CEO)

Dr. Isaac Bentwich (Founder)
Products microRNA-based diagnostic tests and therapeutics
Number of employees
 70 (as of 2008)
Website www.rosettagenomics.com

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.[1] The company expects the first three tests based on its technology to be submitted for regulatory approval in 2008.[2] The diagnostic tests will differentiate between squamous and non-squamous non-small cell lung cancer (NSCLC); differentiate between adenocarcinoma and peritoneal mesothelioma;[3] and seek to identify the origin of tumors in patients representing cancer of unknown primary (CUP).[4] Using a single microRNA, the highly sensitive, highly specific test for squamous and non-squamous lung cancer has passed the prevalidation phase [3] and has been submitted for approval to the New York State Department of Health Clinical Laboratory Evaluation Program in April 2008.[2]

In April 2008, Nature Biotechnology 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.[5] In addition to its diagnostic programs, Rosetta Genomics is collaborating with Isis Pharmaceuticals to develop a microRNA-based therapy for Hepatocellular carcinoma (HCC), a form of liver cancer.[6]

Intellectual property

Rosetta Genomics has developed a microRNA discovery process combining powerful informatics with high-throughput biological techniques.[7] This has led to the discovery of a large portion of today’s known human and viral microRNAs.[8]

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.[9][10]

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.[11] 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.[12]

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.[13]

The Company’s proprietary microarray platform covers approximately 850 human microRNAs, including approximately 180 microRNAs [14] 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 in Detroit, Michigan to develop microRNA-based diagnostics and prognostics for brain cancer.[15] 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.[16] In September 2007, Rosetta Genomics said it will work with New York University Medical Center to develop a microRNA-based diagnostic test for melanoma.[17]

In May 2007, Rosetta Genomics announced Columbia University Medical Center would utilize its Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory to perform the clinical validation of Rosetta Genomics’ diagnostics program for cancer of unknown primary.[18]

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.[19]

History

Rosetta Genomics was founded by Isaac Bentwich in 2000[20] to pursue commercial applications of microRNA research.[21] The company had its IPO on March 6, 2007 and is traded on the NASDAQ.[22] 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.[4]

References

  1. ↑ Chambers, Heather. "Isis, Alnylam Pair To Seek Disease-Fighting Drugs." San Diego Business Journal, September 17, 2007.
  2. 1 2 "Columbia University Medical Center and Rosetta Genomics Announce Columbia University's Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinical Laboratory Evaluation Program," Forbes.com, April 3, 2008
  3. 1 2 "Rosetta Genomics Ltd. Completes Prevalidation Phase for First Diagnostic Production." Reuters, October 30, 2007.
  4. 1 2 Boggs, Jennifer. "Rosetta Genomics' IPO Raising $26.3M For MicroRNA Work."BioWorld Today, February 28, 2007.
  5. ↑ Rosenfeld N, Aharonov R, Meiri E, et al. (April 2008). "MicroRNAs accurately identify cancer tissue origin" (PDF). Nat. Biotechnol. 26 (4): 462–9. doi:10.1038/nbt1392. PMID 18362881.
  6. ↑ "Antisense Oligonucleotide, Heptacellular carcinoma, Isis/Rosetta Genomics Isis, Rosetta Genomics Licensing Agreement." R&D Focus Drug News, March 6, 2006.
  7. ↑ Bentwich I, Avniel A, Karov Y, et al. (July 2005). "Identification of hundreds of conserved and nonconserved human microRNAs" (PDF). Nat. Genet. 37 (7): 766–70. doi:10.1038/ng1590. PMID 15965474.
  8. ↑ http://money.cnn.com/news/newsfeeds/articles/prnewswire/200804280830PR_NEWS_USPR_____UKM006.htm "Rosetta Genomics Announces Expansion Of Its MicroRNA Intellectual Property Estate," CNNMoney.com, April 28, 2008.
  9. ↑ http://news.moneycentral.msn.com/provider/providerarticle.aspx?feed=BCOM&date=20080303 &id=8270968&cid=1138847682&ei=PTnMR4z2N5GO8AK98LyMCQ "Market Report--In Play (WIRES)," msnmoney.com, March 2008.
  10. ↑ http://www.uspto.gov/web/patents/patog/week20/OG/html/1318-3/US07217807-20070515.html USPTO Web site, "USPTO Patent Full-text and Image Database"
  11. ↑ "Other News To Note," Bioworld Today, April 3, 2007.
  12. ↑ "Henry Ford Hospital and Rosetta Genomics To Develop MicroRNA-based Diagnostics For Brain Cancer," Company Reports, January 14, 2008.
  13. ↑ "Nanogen, Inc. Licenses MGB Probe Technology To Rosetta Genomics, Ltd.," Reuters Significant Developments, December 11, 2007.
  14. ↑ "Rosetta and Rockefeller Enter MicroRNA Agreement," Datamonitor News and Comment, June 16, 2006.
  15. ↑ "Business Diary: Acquisitions," Crain's Detroit Business, February 25, 2008.
  16. ↑ http://www.fdanews.com/newsletter/article?articleId=102868&issueId=11189 "Rosetta Genomics Licenses Roche PCR Technology", FDAnews Device Daily Bulletin, January 9, 2008
  17. ↑ Everitt, Jay. "Rosetta Genomics, Ltd--ROSG: To Work In Collaboration With NYU Medical Center," Knobias, September 7, 2007.
  18. ↑ "Rosetta Genomics Ltd. Signs Agreement With Columbia University Medical center," Reuters, May 21, 2007.
  19. ↑ "Isis, Rosetta Join On Cancer Treatment," Associated Press, February 22, 2006.
  20. ↑ http://www.forbes.com/business/forbes/2005/1212/092.html Herper, Matthew and Robert Langreth. "Treasures In The Trash," Forbes, December 12, 2005.
  21. ↑ http://www.hoovers.com/rosetta-genomics/--ID__153400--/free-co-profile.xhtml Hoovers Web site; "Rosetta Genomics Company Description."
  22. ↑ "Alnylam Pharma Shares Rise On Cantor Fitgerald's microRNA Technology Outlook," Associated Press, September 11, 2007.
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