Individuals identified as needing homozygous FH evaluation will receive confirmatory genetic testing from Invitae and genetic counseling from Genome Medical.
Under the terms of the deal, XCR will develop and implement three assays for NeuMoDx's recently launched 288- and 96-sample molecular systems.
The company envisions creating a "vocometer … to provide disease screening and management solutions based on acoustic analysis of seconds of voice."
The PCR-based Carba assay is designed to detect and differentiate bacterial gene sequences that are associated with resistance to carbapenem antibiotics.
For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.
Yikon's test uses next-generation sequencing to screen embryos for chromosomal aneuploidy prior to implantation and does not require a biopsy.
The partnership is directed at streamlining the healthcare workflow and improve decision-making by clinicians and patients related to anticoagulant therapy.
The company filed its first suit against Natera in March, claiming the firm's kidney transplant test infringes patents underlying CareDx's AlloSure test.
Evogen's protein biomarker-based test is designed to stratify actively seizing patients from those who have not experienced a recent seizure.
As of July 1, the Guardant360 test will be considered medically necessary for aiding therapy selection in advanced lung cancer for health plan members of EviCore.
ArcDia will provide Xinhua its biochemical assay components and R&D services in order to localize the Finnish firm's MariPOC testing platform in China.
Bluejay's point-of-care test is designed to measure the presence of human immunoglobulin E in a tear sample, providing results within 10 minutes.
Immunexpress received US clearance for a direct-from-blood sepsis test in 2017 and recently won a contract to commercialize a sample-to-answer sepsis assay.
The company said its higher revenues were due in part to international performance including continued penetration of Middle Eastern and Asian markets.
The test is designed to measure levels of seven auto-antibodies to tumor-associated antigens and can detect all forms of lung cancer at any stage.
The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.
The firm anticipates that it will soon launch the device as an in vitro diagnostic tool for analyzing tissue biopsies during surgeries in European hospitals.
The company, which develops blood-based tests for cancer and autoimmune diseases, expects a second closing of the Series C round in Q2 of this year.
The biomarkers — ubiquitin carboxyl terminal hydrolase-L1 and glial fibrillary acidic protein — can be detected in blood soon after a brain injury.
Qiagen's "Day-One" lab readiness program is designed to expedite patient access to its CDx tests following regulatory approval of the tests and associated drugs.