IVD

The company discussed expectations for how its products will fare against rivals into next year based on recent data and coverage decisions, and on expected reimbursement changes.

Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.

Genomic Health will gain exclusive worldwide rights to develop and sell an IVD version of its Oncotype DX breast cancer test on Biocartis' Idylla platform.

The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.

PSS, which develops tools for the IVD space, will supply to Hitachi its nucleic acid isolation system, fully automated diagnostic instruments, and reagents.

A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.

Ahead of a longer-term goal to develop IVD kits, the company has a plan this year to allow early-access customers to take on one aspect of testing in their own labs.

Glorikian's new book offers guidance for companies looking to develop in vitro diagnostics, on everything from determining value to getting reimbursement.

Tulip Diagnostics Private provides in vitro diagnostic reagents, kits, and instruments to labs, and government and private healthcare facilities in India.

The company said the cartridge now covers 102 diagnostic targets including 85 pathogens and 17 treatment resistance markers.

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Researchers test gene therapy targeting a different cancer protein in a new trial, the New York Times reports.

Pennsylvania State University researchers found that salivary microRNAs could predict which kids would have longer concussion symptoms, according to NPR.

The Associated Press reports Alex Azar, the new Department of Health and Human Services secretary nominee, made millions of dollars as a pharmaceutical executive.

In PNAS this week: immune profiling of breast cancer, transposable element patterns in rice, and more.