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Reagent Problem Could Have Affected Rosetta Genomics' Cancer Test Results

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Problems with a reagent may have affected results from about 100 cancer diagnostics tests, Rosetta Genomics reported on Tuesday after the close of the market.

The affected test is the firm's miRview mets — a molecular test for cancer of unknown primary patients that identifies the tissue of origin of metastatic tumors.

In a document filed with the US Securities and Exchange Commission, the Israeli firm disclosed that problems with a reagent used for testing could have affected results for about 100 miRview mets tests performed in the company's CLIA laboratory between August and October.

Rosetta said it has "remediated the problem, has instituted corrective measures to prevent the problem from occurring again and has already begun testing the potentially impacted patient samples."

Retesting of the samples is expected to take up to 10 days.

The company is in the process of notifying clinicians and recommending they not base decisions on the previous test results until they can be confirmed.

It added that it does not expect the issue to result in material liability to the firm.

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