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FDA clearance

The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi. 

According to Roche, the module "offers greater testing efficiency, superior reagent management, and industry-leading turnaround time for critical diagnostic tests."

The homogenous immunoturbidimetric PCT assay can be used on most clinical chemistry analyzers to measure procalcitonin levels in serum and plasma samples.

The clearance is the first by the FDA for a whole-slide imaging system for reviewing and interpreting digital surgical pathology slides prepared from biopsied tissue.

Alere said that it will promptly apply for a CLIA waiver for use of the Alere Reader and the in vitro immunochromatographic influenza assay.  

BD said that the system provides blood banks and clinical labs with an automated flow cytometer that quantifies the presence of residual white blood cells.

The test provides conclusive visual confirmation of the presence or absence of lesions that could develop into cervical cancer if they are left untreated.

The firm said that expanding the HDL cholesterol measurement range may enable its CardioChek analyzers to serve a larger population.

Lab directors selecting new instruments for antimicrobial testing may wait for clinical proof and then evaluate timing, throughput, and cost.

The test runs on Qiagen's Rotor-Gene Q MDx system and is designed to qualitatively detect the JAK2 V617F/G1849T allele in genomic DNA from whole blood.

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