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Dx Focus Jan 20, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


ARUP Laboratories this week announced the availability of a laboratory-developed test designed to classify breast cancer into clinically significant molecular subtypes that are important for managing the disease.

The new test, called the PAM50 Breast Cancer Intrinsic Classifier, is an RT-qPCR assay that measures the expression of 50 classifier genes and five control genes to identify the intrinsic subtypes known as luminal A, luminal B, HER2-enriched, and basal-like. The test also provides quantitative values for proliferation, luminal gene expression, ESR1, PGR, and ERBB2.

The test is performed by first extracting RNA from formalin-fixed, paraffin-embedded tissue and converting it to cDNA using both random and gene-specific primers. RT-qPCR is then performed on the 55 genes simultaneously in a plate pre-manufactured at ARUP to determine RNA expression levels. Subtype predictions are done using a previously reported centroid-based algorithm, ARUP said.

The development of the PAM50 signature was the result of a decade of work from investigators at the University of Utah, University of North Carolina at Chapel Hill, University of British Columbia, and Washington University School of Medicine.

Virtual company Bioclassifier owns the commercial rights to the PAM50 signature, and in December, it said that ARUP would be launching a laboratory-developed test on the signature this month; and that Seattle's Nanostring had licensed the signature to commercialize a test on its nCounter multiplex gene expression platform (PCR Insider, 12/9/2010).

The Scan

Could Cost Billions

NBC News reports that the new Alzheimer's disease drug from Biogen could cost Medicare in the US billions of dollars.

Not Quite Sent

The Biden Administration likely won't meet its goal of sending 80 million SARS-CoV-2 vaccine doses abroad by the end of the month, according to the Washington Post.

DTC Regulation Proposals

A new report calls on UK policymakers to review direct-to-consumer genetic testing regulations, the Independent reports.

PNAS Papers on Mosquito MicroRNAs, Acute Kidney Injury, Trichothiodystrophy

In PNAS this week: microRNAs involved in Aedes aegypti reproduction, proximal tubule cell response to kidney injury, and more.