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Early Sepsis Indicator receives 510(k) clearance

May 2019—Beckman Coulter’s Early Sepsis Indicator received 510(k) clearance from the Food and Drug Administration.

Beckman Coulter says clinical trial findings showed that its monocyte distribution width biomarker best discriminated sepsis from all other conditions when combined with the current standard of care.

The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with differential for adult emergency department patients. A positive Early Sepsis Indicator result signals a higher probability of sepsis. Compared with reviewing WBC count alone, Beckman Coulter says the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43 percent and, together with clinical signs and symptoms, improves confidence in helping to rule out sepsis by 63 percent.

The indicator can be used in conjunction with the company’s Multidiscipline Reflex Rules in Remisol Advance middleware.

Qiagen launches CDx to help guide metastatic urothelial cancer treatment

Qiagen announced the U.S. launch of its Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic to help guide the use of newly approved FGFR kinase inhibitor Balversa (erdafitinib), developed by Janssen Biotech. The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3) gene. The Food and Drug Administration co-approved the new test with Balversa.

The Therascreen FGFR Kit will run on Qiagen’s Rotor-Gene Q MDx.

An updated list of laboratories offering the new Therascreen FGFR Kit under Qiagen’s Day-One Lab Readiness program is available at www.qiagen.com/fgfr-lab-finder.

FDA clears GenMark 
ePlex BCID-GN panel

GenMark Diagnostics received FDA 510(k) market clearance from the Food and Drug Administration for its ePlex Blood Culture Identification Gram-Negative Panel.