More articles about Diagnostics

ACLA was critical of the report, saying it "fails to reflect market reality" and calling on Congress to intervene to prevent further cuts.

NGeneBio Raises $11M

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 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.

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.

The firm's tool uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy

The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.

The draft guidance has been reissued with updates based on industry comments and is intended to lay out the steps necessary to get simultaneous 510(k) and CLIA waiver approval.

Factors that may have led to the explosion in testing include more consultations between patients and general practitioners, and a fear among GPs of being sued.

In an SEC filing, the company proposed to sell shares of its stock, each coupled with a warrant to purchase up to one additional share.

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.

NeoGenomics estimates that the more than 2,000 community oncologists represent a $2.5 billion testing opportunity. Its CEO called the segment a "strategic priority."

The firms said they will integrate their capabilities and competencies to offer solutions to global pharmaceutical customers.

The new 250,000 square-foot facility will be modeled after the company's Lab of the Future in Marlborough, Massachusetts, and will employ more than 1,100 people.

Pages