A court in San Diego has stated that part of the suit between Quidel and Beckman is void as a matter of law.
The reagent kit is designed to simplify workflow, improve throughput, and reduce hands-on time and labor costs in performing the T-Spot.TB test.
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 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.
The company, established as a merger between A*STAR MedTech spin-off MiRXES and venture capital firm Venturecraft, has developed a blood test for early-stage stomach 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.
HHS Secretary Azar's implementation of PAMA resulted in market-based Medicare prices that don't accurately represent the market, ACLA argues.
The project builds on a collaboration between Bio-Rad and Genetic Analysis using the GA-map clinical test for gut dysbiosis.
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 proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
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.
ACLA was critical of the report, saying it "fails to reflect market reality" and calling on Congress to intervene to prevent further cuts.
The company has also achieved a CE-IVD mark for its HemeAccuTest, which targets hematological malignancies.
November's modest gain followed a tough October, when the index down almost 9 percent. Meridian Bio paced the gainers, and NantHealth was the steepest decliner.
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 partners are developing a point-of-care diagnostic kit that they anticipate will concurrently test for up to 20 types of infectious diseases in 20 minutes.
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.
The company attributed the lower revenue growth to lower volume growth in diagnostics, which is expected to continue for the rest of the year.
Karius said it will use the money to continue commercialization of its diagnostic technologies and to fund clinical studies, among other things.
The firm's tool uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy