The firm plans to use the funds to develop a five-minute point-of-care molecular diagnostic system for multiplexed infectious disease detection.
The lab created active molecular identification tags to be able to track specimens themselves, rather than just their containers.
Under the deal, Novacyt's Primerdesign business will work with Applied Microarrays on the development of microarray-based diagnostic assays.
The agency has been gathering stakeholder input on how to regulate sequencing-based infectious disease diagnostics, including targeted and metagenomic approaches.
The agency cleared a broad array of in vitro diagnostic tests, including assays for influenza, whooping cough, sexually transmitted infections, and opioids.
Premier is a healthcare group purchasing organization representing about 4,000 hospitals and 165,000 other providers throughout the US.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
The companies initially expect to incorporate a CDx for Incyte's pemigatinib into Foundation Medicine's existing FDA-approved assay, FoundationOne CDx.
Expedeon's colloidal gold is an aqueous suspension of uniform, spherical metallic nanoparticles that can conjugate to antibodies and antigens.
The test, based on the next generation of a spinning disk platform, detects three enterotoxins and DNA from three enteric pathogens.
The university health system said that it reduced incorrectly prescribed antiviral prescriptions by almost 11 percent at the sites where it installed the Roche Cobas Liat PCR test platform.
The researchers are testing the method in a clinical trial of hospital-acquired pneumonia and are working on tests for meningitis and prosthetic joint infections.
The company said it plans to list its stock on the Nasdaq under the ticker symbol GH.
The firm reported a 69 percent increase in product sales, driven by a 102 percent jump in cartridge sales and jump in research revenues.
The study is testing the efficacy of cancer treatments that are selected based on genomic markers driving patients' tumors, regardless of cancer type.
The system relies on the use of scannable safety code cards containing patient data, along with a web portal and automated analysis tools that deliver customized diagnostic reports.
The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of the test as an LDT.
The Clinical Treatment Score post-5-years tool helps clinicians identify which patients are at high risk of their cancers recurring after completing five years of adjuvant hormone therapy.
The two firms will provide €14M ($16.2 million) of equity funding to commercialize the Idylla platform in the Chinese market.
Of the 1,194 Horizon 2020 proposals received between 2014 and 2017, most were related to the development of IVDs, while a third were focused on personalized medicine.