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.
The IVD Industry Connectivity Consortium's new LIVD standard promises to support data interoperability by mapping test results directly to LOINC procedure codes.
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 two firms will have the ability to develop instruments for commercialization within the IVD space.
The company said the cartridge now covers 102 diagnostic targets including 85 pathogens and 17 treatment resistance markers.