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FDA clears lysosomal storage disorder test

September 2018—PerkinElmer has received FDA 510(k) clearance for its NeoLSD MSMS kit, an in vitro diagnostic that uses tandem mass spectrometry to screen for six lysosomal storage disorders in newborns via a single dried blood spot sample. The kit is intended for the quantitative measurement of the activity of the enzymes acid β-glucocerebrosidase, acid sphingomyelinase, acid α-glucosidase, β-galactocerebrosidase, α-galactosidase A, ...

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MU School of Medicine, Roche team up

September 2018—Roche announced the result of a collaboration with the University of Missouri School of Medicine to implement the company’s Navify tumor board solution, cloud-based clinical workflow and decision-support software to assist with cancer patient case reviews in tumor board and multidisciplinary team meetings.

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Tibsovo approved for patients with R/R AML with IDH1 mutation

September 2018—Agios Pharmaceuticals announced that Tibsovo (ivosidenib) was granted FDA approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test. Tibsovo is an oral, targeted inhibitor of the IDH1 enzyme. The efficacy of the drug was studied in a single-arm trial of 174 adult patients with relapsed or refractory AML with an IDH1 mutation. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment, as well as patients with no evidence of disease and partial recovery of blood counts after treatment. With a median follow-up of 8.3 months, 32.8 percent of patients experienced complete remission or complete remission with partial hematologic recovery that lasted a median 8.2 months. Of the 110 patients who required transfusions of blood or platelets due to AML at the start of the study, 37 percent went at least 56 days without requiring a transfusion after treatment with Tibsovo.

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Leica rolls out next-gen research stainer

September 2018—Leica Biosystems introduced the Bond Rx next-generation research stainer. The system offers greater flexibility when optimizing conditions for a variety of test types including immunofluorescence, immunohistochemistry, fluorescence in situ hybridization, tyramide signal amplification, multiplexing, and other emerging tests.

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CLSI publishes new method evaluation guideline

September 2018—The Clinical and Laboratory Standards Institute announced the publication of “EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st ed.” EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure’s upper limit of quantitation.

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