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Along with predicting preeclampsia, the Delfia Xpress sFlt-1 kit can be used to help diagnose the condition in the second and third trimesters of pregnancy.
While Sera's previous validation work focused on the 37 and 35 week time points, the 32 week mark is perhaps most crucial in terms of patient outcomes.
The assays quantitatively measure the activity of galactose-1-phosphate uridylyltransferase and biotinidase enzymes from newborn dried blood spot specimens.
The award amount is about $2.3 million, BARDA said, while a Beckman Coulter spokesperson added the full contract is valued at up to $8.06 million.
The firm said that it delivered 27,126 flagship Avise CTD tests, including Avise Lupus, during the recently completed quarter, a 13 percent year-over-year increase.
The combined company will have operations in California and Texas, and will provide onsite, rapid diagnostics with data analytics capabilities.
Under the clearance, capillary whole blood is no longer an acceptable sample type for the company's Blue i-Stat CG4+ cartridge.
The firms are developing a testing system that involves drawing fingertip blood and doing routine testing in Babson's CLIA-certified laboratory.
The company, known for clinical chemistry and molecular biology diagnostic kits, is currently working on two test kits for SARS-CoV-2.
The findings suggest blood-based testing for tau brain deposits is feasible and could be combined with other blood-based assays to improve Alzheimer's testing.
The four kits are compatible with the i-Track automated analyzer for biotherapy monitoring, which received CE marking in late 2019.
The company said the system combined with its Vitros XT 7600 Integrated System completes its suite of Vitros XT Solutions for laboratories.
PerkinElmer is providing its recently FDA-approved test for the program, which has identified one baby, so far, as positive for DMD.
The urine-based test, which was already available in several markets, does not require any specialized instrumentation and produces results in less than three minutes.
The company's Curian immunoassay instrument is currently in front of the FDA, and the PediaStat will likely be submitted later this year.
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.