While the New York Genome Center says whole-genome cancer sequencing is the future, companies already offering such tests are struggling to get paid.
The firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.
The studies involved data from 14,000 Hispanic women and showed the 87-SNP risk score outperformed its 86-SNP score for European women.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
The company said that 20 medical centers in the US are now offering the Envisia Genomic Classifier through an early-access program begun in May.
The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
The company said its test is the first biomarker-based diagnostic for IBD that predicts long-term disease outcome in Crohn's disease and ulcerative colitis.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
A comprehensive study of genomics malpractice lawsuits showed only a modest increase in recent years, but ASU’s Marchant wouldn't bet on it staying this way in the long term.
Following promising data from its Circulating Cell-free Genome Atlas study, the firm decided to pivot its breast cancer trial to support its multi-cancer test.
Genomic Health will have exclusive rights to develop and sell its Oncotype DX Genomic Prostate Score test on Biocartis' Idylla platform.
The disease is an inherited form of muscular dystrophy characterized by a repeat expansion of 50 CTG trinucleotides or greater in the DMPK gene.
The company has also achieved a CE-IVD mark for its HemeAccuTest, which targets hematological malignancies.
The company, which changed its name from Premaitha Health last month, saw a 73 percent increase in testing volumes during the first half of fiscal year 2018.
The effort is one of five being undertaken by MDIC's Clinical Diagnostic Program designed to expedite the regulatory process for clinical diagnostics.
The molecular test detects a form of herpes virus that can infect newborns and cause deafness.
Qiagen will provide IUO tests for NeoGenomics to verify, set up, and run in clinical trials and in anticipation of regulatory approval.
Led by investigators at the University of Trento in Italy, the team received a five-year, £5 million ($6.4 million) award recently to advance its work.
Karius said it will use the money to continue commercialization of its diagnostic technologies and to fund clinical studies, among other things.
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.
Senator Lamar Alexander (R-Tenn.), who chairs the Senate health committee, will be retiring at the end of his term, Stat News reports.
UCSF researchers find that having two X chromosomes may contribute to women's longer lifespans, according to Discover's D-brief blog.
The Wall Street Journal reports on the US Centers for Disease Control and Prevention's use of genetic approaches to study foodborne illnesses.
In PNAS this week: immune cell profiling of wild baboons by social status, metabolomics profiling of esophageal tumors, and more.