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BD will supply its diagnostics and informatics products as part of the contract with Fleming Fund to take on AMR in Asia and sub-Saharan Africa.

The company announced Monday that it has inked a contract to become the primary supplier of products for immunoassay testing to Quest Diagnostics.

Eurofins LifeCodexx will commercialize Osteolabs' osteoporosis test in Germany, while BioGen Medical will do the same in Turkey.

The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.

The FDA-cleared and CE-marked assay detects both fentanyl and norfentanyl, allowing labs to identify more true positives, according to Siemens.

Framingham, Massachusetts-based Kephera's tests is intended to be used to differentiate neurocysticercosis from other causes of seizures in patients.

The alliance will leverage Charleston, Veravas' sample prep technology and Tymora's extracellular vesicle enrichment technology.

The funding will be used to bring to market Oklahoma City-based Progentec's products for CLIA labs, as well as its digital technologies for managing lupus.

The French company sold the Novaprep assets to Belarus-based Algimed following a strategic review a year ago. It will now focus on the Primerdesign and Lab21 businesses.

The firm is performing a clinical trial for Finder in preparation of a 510(k) submission to the FDA, anticipated in early 2020, it said.

The company's newest products and planned updates reveal a focus on operational efficiency and increasing automation for core lab management.  

 

As part of the expanded deal, Oncore will offer StageZero's BreastSentry and Prostate Health Index tests, as well as ColonSentry.

A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.

 

Apatagen is developing the aptamer-based test to diagnose human carriers of pork tapeworm and prevent neurocysticercosis, which causes adult-onset epilepsy.

The company's point-of-care platform combines clinical chemistry, immunoassays, and hematology technology to run a range of diagnostic tests. 

 

The company is developing an automated benchtop system to provide accurate lab results in 20 minutes for a variety of tests from a small sample of blood. 

The test, which is in development using perspiration as a sample, has shown promising performance in a preliminary study.

The test will now be considered medically reasonable and necessary for patients over 45 with moderately elevated levels of prostate-specific antigen. 

Since the FDA issued its safety communication in 2017, some lab test developers have mitigated the biotin interference of their assays, but others have not.

Siemens Healthineers will use the technology, which Quanterix acquired as part of its buy of UmanDiagnostics, to develop blood-based Nf-L clinical tests.

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