A recent study established high sensitivity and specificity for three CLIA waived point-of-care molecular flu tests in pediatric samples.
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 firms will collaborate to develop a blood collection device and automated sample handling and analytic technologies for use in decentralized testing.
The firm is lowering its guidance due to anticipated revenue loss related to remediation efforts associated with its Alaris pump system.
BD said TRC Capital Investment had made an unsolicited offer to BD shareholders to buy up to 500,000 shares of BD's stock at a price below the current market value.
The assay, which received premarket approval last year, detects 14 high-risk HPV types and individually identifies and reports HPV genotypes 16, 18, and 45.
For fiscal 2020, BD provided guidance for revenue growth in the 4 to 4.5 percent range, or 5 to 5.5 percent on a currency-neutral basis.
The test is the latest in a series of CE-IVD-marked assays the company has launched for use on Becton Dickinson's PCR-based BD Max platform.
Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.