CDx development

Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation.

The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi.

Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.

The companies will work together to develop a next-generation sequencing-based companion diagnostic for an undisclosed cancer therapy.

SkylineDx said that the firms will work together to develop predictive immunological signatures for BioInvent's lead therapy candidate.

The companies initially plan to validate biomarkers for use with the Oncomine Dx Target Test to identify NSCLC patients for enrollment into clinical trials.

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

ArcherDx will develop in vitro diagnostic tests, including companion diagnostics, to run on Illumina's NextSeq 550Dx next-generation sequencing system.

Asuragen will use its Amplidex PCR tech to develop companion diagnostics for Wave's investigational allele-selective therapeutic programs for Huntington's.

Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.