The tests run on the firm's sample-to-result automated molecular diagnostics instruments designed for use by high-volume labs.
NYU Winthrop has granted Progenity an exclusive license to patents that it holds covering a biomarker for predicting preterm births.
The deal covers the PlexBio IntelliPlex diagnostic instrument platform and reagent kits for oncology and infectious disease testing.
Transplant Genomics offers a test that assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection.
FDNA has developed software called Face2Gene that uses facial anomalies, phenotypic traits, and variant information to diagnose genetic disorders.
The firm is also developing a methylated DNA biomarker test — called EsoCheck Dx — for Barrett's esophagus that uses samples collected with EsoCheck.
AmoyDx and Premia will provide large-scale cancer patient screening in Asia to support Loxo-292 RET inhibitor clinical development.
A combination of three biomarkers accurately predicted abnormal accumulation of beta-amyloid plaques in the brains of living Alzheimer's disease patients.
SpeeDx said it will work with GlaxoSmithKline on tests to support its antibiotic clinical trials, as well as its new product development efforts.
MSK-ACCESS sequences 129 cancer-associated genes selected from the MSK-IMPACT assay and is designed to detect gene alterations in cfDNA specimen.
The company's patent related to labeled nucleotides for use as diagnostic tools and as therapeutic agents has been invalidated.
An Australian team developed a decision model for testing asymptomatic relatives of patients with dilated cardiomyopathy to assess the cost effectiveness of testing.
The organizations provided a list of genes they believe are informative in treatment of myeloid disorders and suggested several changes to the coverage policy.
The test is designed to determine whether a patient with a pelvic mass is at high risk of having ovarian cancer and should be referred for surgery.
Under the determination, which will become final following publication in Germany's Federal Gazette, Oncotype DX becomes the only multigene test nationally reimbursed in Germany for its target population early-stage breast cancer patients.
The test, cleared for use with Quidel’s Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes.
The investment bank cited management confidence in US and European test growth as meriting the upgrade, which was necessary to maintain a current $72 price target on the firm's stock.
The firm is developing a portable, rapid MDx platform for infectious disease testing in clinics, and anticipates launching a first product in 2020.
Interpace Diagnostics' ThyGeNext and ThyraMir thyroid cancer assays are now covered for about 2.5 million patients in Philadelphia and Southeastern Pennsylvania.
McKesson will be the exclusive distributor of the QiaStat-Dx system in US hospitals with fewer than 200 beds and non-exclusive distributor for future expansion into retail pharmacy clinics.
The new grant will be used to conduct whole-exome sequencing on 1,000 children participating in an autism spectrum disorder study for the purposes of biomarker development.
The firm said it anticipates using the financing to support working capital requirements, platform development, and pilot manufacturing.
The complaint alleges that NeuMoDx is willfully infringing on six BD-held patents, and demands injunctive relief, damages, and a jury trial.
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.