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Detecting women at risk

Myriad Genetics presented clinical data at the 2013 San Antonio Breast Cancer Symposium in December that showed the myRisk Hereditary Cancer test found 51 percent more patients with a higher risk of hereditary breast and ovarian cancer than did testing for the BRCA1 and BRCA2 genes alone.

MyRisk is a diagnostic test that uses next-generation sequencing to evaluate 25 genes associated with eight hereditary cancers.

This large prospective clinical validation study measured mutations in 25 cancer-causing genes among patients referred for BRCA1/2 testing. Among the 1,951 patients evaluated, 275 patients tested positive for a deleterious mutation with the myRisk test. Testing only for the BRCA1 and BRCA2 genes found 182 of the mutation carriers.

MALDI Biotyper CA cleared

Bruker has been granted FDA 510k clearance to market its MALDI Biotyper CA system in the U.S. for the identification of gram-negative bacterial colonies cultured from human specimens. The system includes the benchtop microflex MALDI-TOF mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target, and a library of microorganism reference spectra.

Frank Laukien, president and CEO of Bruker, said in a statement that more than 1,000 MALDI Biotyper systems have been sold or leased worldwide.

Robert Jerris, PhD, D(ABMM), director of clinical microbiology at Children’s Healthcare of Atlanta, said in the statement that MALDI-TOF has helped lower health care expenditures at Children’s and has had a positive impact on therapy and infection control.