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.
In an SEC filing, the company proposed to sell shares of its stock, each coupled with a warrant to purchase up to one additional share.
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.
Researchers hope that understanding the etiology of inappropriate testing will help them design a better computerized support tool.
The test is the first whole-genome-based cancer test to receive approval from New York State's Department of Health.
The university will use the technology to screen blood samples for certain clinically actionable mutations in non-small cell lung cancer patients.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
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 agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.
The companies will bring NIPD Genetics' Veracity and Veragene noninvasive prenatal tests to Medicover's markets, as well as developing new genetic tests.
The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.
The companies will evaluate the performance of Proteomics International's PromarkerD test for predicting decline in kidney function and drug response.
LGC said the acquisition will improve its position across the clinical quality control tools market and increase its proficiency testing offerings.
The company and Women & Infants Hospital of Rhode Island are currently evaluating the technology to determine the performance of the test.
With the approval, MDxHealth can now offer its liquid biopsy molecular diagnostic assay in all 50 US states.
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.
The partners will use a $5M NCI grant to add seven biomarkers to an EGFR electrochemical assay for non-small-cell lung-carcinoma.