IVD

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.

The diagnostics provider said it has paid $250,000 for assets comprised of promissory notes, Series A and Series B stock, and intellectual property.

The finalized guidance sets requirements for label implementation, electronic labeling, symbols on small containers, and blood glucose monitoring systems.

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The Jackson Laboratory has filed a complaint accusing Nanjing University of breeding and re-selling its mouse models, the Hartford Courant reports.

Oxford researchers are turning to virtual reality to visualize genes and regulatory elements, Phys.org says.

In Science this week: neutrophils rely on microRNA to protect against lung inflammation, and more.

China is moving forward with plans to sequence a million citizens, the Wall Street Journal reports.