The UK developers believe that their device has the potential for multiplex testing at the point of care using solid-state nanopore sensing with DNA probes.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
Australian Clinical Labs will take over the the clinical pathology and reporting responsibilities of Garvan Institute of Medical Research subsidiary Genome.One.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
As part of the deal, which is worth at least $3 million for the first five years, Primerdesign will develop and supply 384-well plate molecular assay panels for Genesis.
The companies will bring NIPD Genetics' Veracity and Veragene noninvasive prenatal tests to Medicover's markets, as well as developing new genetic tests.
The test is designed to detect clinically relevant genomic alterations — including somatic mutations, microsatellite instability, and viral DNA from ctDNA — in blood.
Before broad implementation, the healthcare system will gauge the feasibility of the screening program, patient impact, and cost-benefit in a pilot phase.
