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FDA clears third Panther Fusion assay

Dec. 6, 2017—Hologic announced that it has received FDA 510(k) clearance for its Panther Fusion AdV/hMPV/RV assay running on the …

FoundationOne CDx for solid tumors gets FDA OK

Dec. 1, 2017—Foundation Medicine announced Nov. 30 that the FDA approved FoundationOne CDx for solid tumors. The test is intended …

Study: fewer biopsies for men tested with phi

Nov. 29, 2017—A study published in Prostate Cancer and Prostatic Diseases (White J, et al. Epub ahead of print Nov. 20, …

EKF PCT assay cleared for Beckman AU analyzers

Nov. 29, 2017—EKF Diagnostics announced that its Stanbio Chemistry Procalcitonin LiquiColor assay has been FDA cleared and validated for use …

Promega offers modular nucleic acid prep system

Nov. 28, 2017—A modular automated liquid handling and purification system developed by Promega for its Maxwell nucleic acid preparation allows …

FDA approves Roche’s alectinib product

Nov. 27, 2017—Roche announced that the FDA approved the supplemental new drug application for Alecensa (alectinib) for the treatment of …

Quidel’s Sofia Lyme FIA gets FDA approval

Nov. 27, 2017—Quidel received 510(k) clearance from the United States Food and Drug Administration to market its Sofia Lyme FIA …

FDA authorizes MSK tumor profiling test

Nov. 24, 2017—The FDA announced the authorization of MSK-IMPACT (integrated mutation profiling of actionable cancer targets), a high-throughput…

Adcetris gets FDA nod for pcALCL

Nov. 22, 2017—The FDA granted approval to Seattle Genetics’ Adcetris (brentuximab vedotin) for the treatment of adult patients with primary …

Sysmex hematology analyzer gets CLIA waiver

Nov. 21, 2017—Sysmex received FDA approval for its XW-100 automated hematology analyzer as a CLIA-waived product. The CLIA waiver for …

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