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regulatory approval

The approval from SFDA will help the company increase its market presence in China where the IVD market is estimated at $2 billion per year.

The test, which was launched in late 2009, detects methylated DNA of the Septin-9 gene, which Quest licensed from Epigenomics. It is targeted at people 50 years of age and above who should be screened for colon cancer but resist.

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 former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.