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Author Archives: Kristen

Thermo Fisher’s blood test for Ara h 6 approved

Jan. 28, 2019—Thermo Fisher’s ImmunoCAP Specific IgE blood test for Ara h 6, part of a line of assays for detecting specific peanut allergen components, has been cleared by the FDA for in vitro diagnostic use. The test is designed to help allergists and other medical providers better predict which patients may be at risk for life-threatening sensitization to Ara ...

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FDA clears DiaSorin Bordetella test

Jan. 16, 2019—DiaSorin Molecular has received FDA clearance for its new Simplexa Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the Liaison MDX to provide qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis. The assay is performed directly from nasopharyngeal swab samples without extraction and provides results in about an hour. “We are very ...

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Health Network Labs buys Connective Tissue Gene Tests

Jan. 15, 2019—Health Network Laboratories has acquired Connective Tissue Gene Tests LLC (Allentown, Pa.), a provider of molecular diagnostic testing services for inherited genetic disorders. CTGT uses its proprietary analytic methods, mutation database, and technology to provide more than 3,300 unique tests covering more than 1,000 genes. “The acquisition of CTGT will complement HNL’s comprehensive clinical genetic laboratory service programs ...

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Luminex acquires MilliporeSigma’s flow cytometry portfolio

Jan. 14, 2019—Luminex has completed its acquisition of MilliporeSigma’s flow cytometry portfolio for $75 million. The flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis and the Guava portfolio of microcapillary flow cytometry systems. “The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we ...

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BD Max enteric panel gets FDA clearance

Jan. 11, 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. The panel is designed for targeted detection of the viral cause of infectious diarrhea symptoms and can detect norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus. “We continue ...

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FDA clears two ePlex blood culture identification panels

Dec. 28, 2018—GenMark Diagnostics has received FDA 510(k) market clearance for its ePlex Blood Culture Identification Fungal Pathogen Panel. This panel, together with the ePlex Blood Culture Identification Gram-Positive Panel, which received FDA clearance Dec. 20, and Gram-Negative Panel were developed for the diagnosis and disease management of bloodstream infections that can lead to sepsis. “Receiving FDA clearance for two of our ...

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Beckman Coulter releases cloud-based middleware solution

Dec. 21, 2018—Beckman Coulter announced the U.S. release of its DxOne Workflow Manager, cloud-based middleware that aims to help low-volume laboratories standardize workflows, automate processes, and consolidate information. Technologists can manage samples by exception using autoverification and can get an at-a-glance view of ordering information and patient demographics on one screen. Comments and flags are readily visible, alerting users to ...

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Hycor gets clearance for Noveos allergy testing instrument

Dec. 20, 2018—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports. “Hycor has a long history of being at the forefront of allergy ...

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