Shots:
- The US FDA has granted 510(k) Clearance for Aptiva’s APS IgG & APS IgM reagents, expanding its portfolio from Celiac Diseases & CTD essential reagents to 18 FDA-cleared analytes
- The APS reagents semi-quantitatively detect anti-cardiolipin (aCL), plus anti-β2 glycoprotein 1 (aβ2GP1) IgG & IgM in serum levels, aiding in diagnoses of 1° & 2° APS alongside other laboratory & clinical findings
- Aptiva is a fully automated multi-analyte system that enables high volumes of lab testing through its PMAT tech. to deliver ~960 result in 8hrs. for APS testing. Werfen will expand the Aptiva portfolio to additional autoimmune diseases with 60+ analytes in development
Ref: Prnewswire | Image: Werfen
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