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 is developing a new gold standard comparator test after it encountered problems with typical culture methods it used in developing a new pneumonia assay.
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
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The draft guidance has been reissued with updates based on industry comments and is intended to lay out the steps necessary to get simultaneous 510(k) and CLIA waiver approval.
For 2018, Quest lowered its revenues expectation to $7.57 billion, its EPS to greater than $5.34, and its adjusted EPS to greater than $6.30.
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.
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.
The firms said they will integrate their capabilities and competencies to offer solutions to global pharmaceutical customers.
The firm received approval for expanded use of its HIV Combo test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen, on its Vitros ECi/ECiQ Immunodiagnostic System.
Australian Clinical Labs will take over the the clinical pathology and reporting responsibilities of Garvan Institute of Medical Research subsidiary Genome.One.
The university will use the technology to screen blood samples for certain clinically actionable mutations in non-small cell lung cancer patients.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
Roche will develop an immunohistochemistry-based companion diagnostic for Daiichi's investigational HER2-targeting antibody conjugate for breast cancer.
The agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.
The companies will bring NIPD Genetics' Veracity and Veragene noninvasive prenatal tests to Medicover's markets, as well as developing new genetic tests.
The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.