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Rosetta Aims to Launch New microRNA Test Annually Starting Next Year

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Rosetta Genomics this week announced updates to its pipeline of microRNA-based diagnostics and therapeutics, stating that it will start commercializing one new assay a year as it moves a treatment for cytomegalovirus (CMV) infection toward the clinic.

Notably, some of these diagnostics will be for indications outside of cancer, which has been the company's main area of interest.

Rosetta was founded in 2000 to develop both miRNA diagnostics and therapeutics, but later shifted its focus to diagnostics, primarily for cancer indications.

To date, the company has launched four tests: the Cancer Origin Test to determine the source of cancers of unknown primary origin; the Lung Cancer Test, to differentiate lung primary tumors into small cell lung cancer, carcinoid, squamous non-small cell lung cancer (NSCLC), and non-squamous NSCLC; the Kidney Cancer Test, to differentiate the four main histological types of primary kidney tumors; and the Mesothelioma Test, to differentiate malignant pleural mesothelioma from carcinomas in the lung and pleura.

All four tests analyze miRNA signatures in tissue samples.

All the while, the company kept some therapeutics research ongoing, primarily through Israeli government-funded collaborations with academic groups.

This week, Rosetta said that it is adding several programs to its diagnostics pipeline, beginning with a test to differentiate malignant thyroid neoplasms from benign ones in fine needle aspirate samples.

The company said it aims to launch this assay before the end of 2015.

Meanwhile, the firm said it is looking to expand its oncology diagnostics portfolio, potentially with tests to determine the risk of bladder cancer invasiveness, predicting the responses of ovarian cancer patients to treatment, or assisting clinicians in managing breast cancer. Rosetta expects to commercialize a product in this disease area before the end of 2016.

Outside of cancer, the company is developing a test that will use miRNA signatures from either blood or urine to identify kidney transplant patients who will experience transplant rejection, with a goal of commercialization in 2017.

The company is also working on a blood-based test for the early diagnosis of heart failure and the risk stratification of patients following heart attack, and anticipates having a product ready for the market in 2017.

Finally, Rosetta is preparing to begin studies this year to demonstrate that it can use miRNA signatures in cerebrospinal fluid to diagnose Alzheimer's disease. A potential launch date for this product was not provided.

On the therapeutics front, Rosetta said that it is currently in the discovery stage of a program developing an miRNA-inhibiting drug for CMV, a common infection that can be fatal in patients with immature or compromised immune systems. The company expects to have selected a lead candidate by the third quarter of this year, and expects to conduct additional preclinical and clinical work on the agent in collaboration with a partner.

Meanwhile, the company is collaborating with researchers at Tel Aviv University and at Rimonim, an Israeli-sponsored industry/academic consortium, on miRNA mimetics to treat cancer and other diseases.

Rosetta said that if these projects are successful it will use the technologies for internal projects and look to partner them with other therapeutics companies.

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