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regulatory approval

The serum-based proteomics test is now available in all 50 states.

The test, which was cleared by the FDA in June, can now be offered in New York.

China's State Food and Drug Administration granted approval for its EGFR and BRAF tests for clinical use.

The firm also said it plans to expand its molecular diagnostics menu over the next several months.

According to the company, the kit is the first molecular diagnostic assay to receive approval in China for use in personalized clinical testing in oncology.

The firm said that its test is the first PCR-based EGFR assay approved by the State Food and Drug Administration of China.

The illumigene C. difficile assay detects the presence of the toxin-producing region from the bacterium and provides highly accurate results in under an hour, according to Meridian.

The approval by the New York State Department of Health now makes Quest's XSense Fragile X with Reflex available in all 50 states.

The Pharmaceuticals and Medical Devices Agency's decision follows similar decisions by the FDA and EMA in 2008, which allowed data generated using the seven-biomarker panel to be included in the drug approval process.

China's food and drug regulator has cleared two microarray tests and an amplification test for identifying and differentiating tuberculosis.


A UK woman is suing three National Health Service Trusts for not telling her about her father's Huntington's disease diagnosis, the BBC reports.

LiveScience reports that a novel mutation in the LPL gene was uncovered in three siblings with very high triglyceride levels.

The president of Nankai University is embroiled in a data manipulation scandal, the South China Morning Post reports.

In PNAS this week: cytotoxic CD4 T cell signature in supercentenarians, evolutionary history of beetles, and more.