Rosetta Genomics

Rosetta Genomics was founded in 2000 by Isaac Bentwich with the aim of developing commercial applications for microRNA research. MicroRNAs are short RNA molecules that regulate gene expression, and their patterns of presence or abundance can provide information about cell type, disease state, and tumor biology. Rosetta Genomics built its business around the premise that these patterns could support diagnostic decisions that were difficult to make using conventional pathology alone. The company's research program focused particularly on oncology. It sought to create tests that could distinguish squamous from non-squamous non-small-cell lung cancer, separate adenocarcinoma from peritoneal mesothelioma, and identify the likely origin of tumors in patients diagnosed with cancer of unknown primary. These programs addressed situations in which treatment selection depends on accurate classification but available tissue or morphological evidence is limited. Rosetta Genomics also pursued diagnostic and prognostic work in melanoma and brain cancer and explored therapeutic applications in hepatocellular carcinoma. To support these programs, Rosetta Genomics developed proprietary methods for extracting miRNAs from a range of biological and preserved clinical samples. The company described protocols for serum, urine, saliva, and formalin-fixed, paraffin-embedded tissue. It then used quantitative real-time PCR and custom microarrays to detect and quantify miRNAs. Its stated microarray coverage included roughly 850 human miRNAs, among them approximately 180 proprietary sequences, and was designed to discriminate between closely related miRNA family members. Rosetta Genomics expanded its development network through academic, healthcare, and industry partnerships. In 2006, it announced a collaboration with Isis Pharmaceuticals to investigate antisense drugs that could inhibit liver miRNAs in cancer. In 2007, it announced work with Columbia University Medical Center, whose CLIA-certified laboratory was to support clinical validation for the cancer-of-unknown-primary program, and with New York University Medical Center on a melanoma diagnostic. In 2008, Henry Ford Health System became a collaborator on brain-cancer diagnostics and prognostics. Rosetta Genomics' US subsidiary also received a license to use Roche Molecular Systems PCR technology in miRNA-based diagnostic tests. The company went public on March 6, 2007. Funds from the offering were intended to move diagnostic and therapeutic programs toward clinical validation, including blinded testing of samples supplied by medical institutions. In April 2008, a Rosetta Genomics study appeared in Nature Biotechnology and reported evidence supporting the use of miRNA patterns to identify the primary tumor site in cancer-of-unknown-primary cases. During the same period, the company stated that its lung-cancer classification assay had completed prevalidation and had been submitted to the New York State Department of Health Clinical Laboratory Evaluation Program. It also projected regulatory submissions for several early tests. Rosetta Genomics was later recognized in Deloitte's 2016 Fast 500 North America ranking, where it was listed at number 27. The company's subsequent corporate history was less stable. In 2017, it was sold to Genoptix, a private US company, for a reported $10 million. On May 31, 2018, Rosetta Genomics was reported to have filed for Chapter 7 bankruptcy. The company is consequently a historical, defunct diagnostics business. Publicly available material emphasizes its platform research, clinical collaborations, and development pipeline; it does not establish a broad continuing portfolio of branded commercial products after the bankruptcy.

• 2018

  Chapter 7 bankruptcy filing

  [1]Rosetta Genomicsen.wikipedia.org

  Rosetta Genomics filed for Chapter 7 bankruptcy on May 31, 2018.

• 2017

  Acquired by Genoptix

  [1]Rosetta Genomicsen.wikipedia.org

  The company was sold to private US company Genoptix for a reported $10 million.

• 2016

  Listed in Deloitte Fast 500 North America

  [1]Rosetta Genomicsen.wikipedia.org

  Rosetta Genomics was ranked number 27 in Deloitte's Fast 500 North America list.

• 2008

  Lung-cancer assay reaches regulatory submission

  [1]Rosetta Genomicsen.wikipedia.org

  A microRNA-based test intended to distinguish squamous and non-squamous non-small-cell lung cancer passed prevalidation and was submitted to the New York State Department of Health laboratory program.

• 2007

  Initial public offering

  [1]Rosetta Genomicsen.wikipedia.org

  Rosetta Genomics completed its IPO and began trading on NASDAQ on March 6, 2007.

• 2007

  Clinical and research collaborations expand

  [1]Rosetta Genomicsen.wikipedia.org

  The company announced collaborations with Columbia University Medical Center for cancer-of-unknown-primary validation and New York University Medical Center for melanoma diagnostics.

• 2006

  Antisense therapy collaboration with Isis Pharmaceuticals

  [1]Rosetta Genomicsen.wikipedia.org

  Rosetta Genomics and Isis Pharmaceuticals began collaborating on antisense approaches intended to inhibit liver microRNAs in hepatocellular carcinoma.

• 2000

  Company founded

  [1]Rosetta Genomicsen.wikipedia.org

  Isaac Bentwich founded Rosetta Genomics to pursue commercial uses for microRNA research.

A specialist molecular-diagnostics company focused on translating microRNA biomarkers into cancer classification, tumor-origin, prognostic, and therapeutic applications.

• Molecular diagnostic

  Lung-cancer classification test

  A microRNA-based assay designed to differentiate squamous from non-squamous non-small-cell lung cancer. The test used a single microRNA marker according to the reference material, had completed prevalidation, and was submitted to the New York State Department of Health's Clinical Laboratory Evaluation Program in 2008.

• Molecular diagnostic

  Cancer-of-unknown-primary test

  A diagnostic program intended to identify the likely primary tumor site in patients whose cancer had been detected but whose original site could not be established through routine clinical investigation. The program was supported by clinical validation work involving Columbia University Medical Center and by published research on miRNA signatures.

• Molecular diagnostic

  Adenocarcinoma and peritoneal mesothelioma test

  A proposed microRNA-based assay intended to distinguish adenocarcinoma from peritoneal mesothelioma. It was one of the company's early planned cancer diagnostic products, but the available material does not establish a commercial launch or final regulatory status.

• Biotechnology platform

  MicroRNA extraction and profiling platform

  A set of proprietary laboratory methods for extracting microRNAs from fluids and preserved tissue, followed by detection and quantification using quantitative real-time PCR and microarrays. The platform was intended to retain sensitive biomarker material from serum, urine, saliva, and formalin-fixed, paraffin-embedded samples.

• Therapeutic research · 2006

  MicroRNA-based hepatocellular carcinoma therapy program

  A research collaboration with Isis Pharmaceuticals investigating antisense drugs designed to inhibit liver microRNAs involved in hepatocellular carcinoma. This was a therapeutic development program rather than an established marketed medicine.

• 2017

  Sale to GenoptixM&A

  Background

  Rosetta Genomics changed ownership after a period of developing microRNA diagnostic and therapeutic programs as a public company.

  Action taken

  The company was sold to private US company Genoptix.

  Aftermath

  The sale was followed by Rosetta Genomics' reported Chapter 7 bankruptcy filing in 2018.

  Reported sale price. $10 million (2017)

  Source

• 2008

  Submit lung-cancer classification assay for regulatory reviewProduct launch

  Background

  Rosetta Genomics had developed a microRNA-based test intended to differentiate squamous and non-squamous non-small-cell lung cancer.

  Action taken

  Following prevalidation, the company submitted the assay to the New York State Department of Health Clinical Laboratory Evaluation Program.

  Aftermath

  The reference material does not specify the final regulatory outcome or establish a sustained commercial launch.

  Source

• 2007

  Use IPO proceeds to advance clinical validationStrategy

  Background

  After becoming publicly traded, Rosetta Genomics planned to use the funds raised to move its microRNA-based cancer diagnostics and therapeutics toward initial clinical validation.

  Action taken

  The company directed its development strategy toward blinded testing of clinical samples and identification of diagnostic biomarker panels.

  Aftermath

  The company subsequently reported progress on its lung-cancer assay and other diagnostic collaborations, although the available material does not document a complete commercial product rollout.

  Source

1. 1Rosetta Genomicsen.wikipedia.org