New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Plans are in place for a Guardant360-based assay to predict response to AsztraZeneca's Tagrisso and for a blood-based TMB test using the larger GuardantOmni panel.
The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.
Qiagen and Foundation Medicine will develop tissue- and plasma-based companion tests to identify best responders to the PI3K inhibitor alpelisib
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
New data on Kadcyla and Tecentriq will help doctors further refine precision medicine options for breast cancer patients with unmet needs.
Qiagen will provide IUO tests for NeoGenomics to verify, set up, and run in clinical trials and in anticipation of regulatory approval.
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.
The firms said they will integrate their capabilities and competencies to offer solutions to global pharmaceutical customers.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
The company submitted the test to Japanese regulators for approval as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.
Almac is developing the assay to enroll patients for clinical trials used to develop repotrectinib, an investigational tyrosine kinase inhibitor.
The test is intended to identify patients with ROS1, NTRK, and ALK gene fusions for treatment with TP's investigational drug repotrectinib.
The collaboration agreement includes support for development, regulatory submission, and commercialization of tests to guide use of Novartis' drug portfolio.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
Researchers have sequenced the genome of the depth-dwelling giant squid.
Prosecutors have charged a former Drexel University professor with theft for allegedly spending federal grant money on adult entertainment and other unrelated expenses, according to the Philadelphia Inquirer.
Chris Collins, a former US representative, has been sentenced to more than two years in prison in an insider trading case involving an Australian biotechnology firm, the New York Times reports.
In PNAS this week: Trypanosoma brucei transcripts, estimate of people at risk of inherited retinal disease, and more.