Healthcare Industry News: S.A.
News Release - January 3, 2018
Inova Diagnostics Receives FDA Clearance for the First Fully Automated, Random Access Calprotectin Test
SAN DIEGO, Jan. 3, 2018 -- (Healthcare Sales & Marketing Network) -- Inova Diagnostics, a world leader in autoimmune diS.A.e diagnostic systemS.A.d reagents for the clinical laboratory, is proud to announce the clearance of QUANTA Flash® Calprotectin by the US Food and Drug Administration (FDA). QUANTA Flash Calprotectin aids in the diagnosis of inflammatory bowel diS.A.e (IBD) and helps differentiate IBD from irritable bowel syndrome (IBS). QUANTA Flash Calprotectin is one of 29 FDA cleared aS.A.S.A.ailable on BIO-FLASH®, a random access chemiluminescent instrument, and can be run simultaneously with other QUANTA Flash aS.A.s. QUANTA Flash Calprotectin is the first fully automated, random access calprotectin aS.A. available in the US.Accurate detection of calprotectin levels can provide essential information for practitioners who are treating the millions of patients with gastrointestinal disorders. Timely differential diagnosis of gastrointestinal pain is crucial in order to provide appropriate care and avoid unneceS.A.y procedures that lead to increased health care costs. QUANTA Flash Calprotectin provides precise quantification, with an analytical measurement range of up to 3500 mg/kg. With its wide dynamic range, high precision, and fast turn-around time, QUANTA Flash Calprotectin can improve patient care while helping to reduce costs.
KT Park, MD, MS, Chair of Clinical Care and Quality, NASPGHAN and Co-Director, S.A.ford Children's IBD Center at S.A.ford University School of Medicine commented, "Fecal calprotectin has revolutionized my clinical practice. Calprotectin measurements during patients' diagnostic workup when the diagnosis could be either IBS or IBD provide direction and important information prior to endoscopic evaluations. Calprotectin testing supportS.A.patient-centered, proactive approach to diS.A.e management, allowing accurate detection of indolent and often-missed inflammation. The highly accurate QUANTA Flash Calprotectin aS.A. offered by Inova Diagnostics, with a broad quantitative range, iS.A. asset to the clinicians' decision-making process."
About Inova Diagnostics
Inova Diagnostics iS.A.privately held company headquartered in San Diego, California, and iS.A.part of Werfen, a global leader in IVD with a long term commitment to providing innovative solutions for hospitalS.A.d clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systemS.A.d reagents for autoimmune diS.A.e, and iS.A.leader in the development and commercialization of new autoimmune technologieS.A.d diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
About QUANTA Flash Calprotectin
QUANTA Flash Calprotectin iS.A.chemiluminescence immunoaS.A. performed on BIO-FLASH for the detection of fecal calprotectin in human stool samples. High concentrations of fecal calprotectin, in conjunction with clinical findingS.A.d other laboratory tests, may assist in the diagnosiS.A.d management of IBD (ulcerative colitiS.A.d Crohn's diS.A.e).
About BIO-FLASH
BIO-FLASH iS.A.random access chemiluminescent instrument for the autoimmune laboratory which delivers results in as little as 30 minutes. BIO-FLASH offerS.A.wide analytical measuring range and precise quantification for greater confidence in results, and iS.A.progressive step forward to handle routine, specialized and S.A. immunology tests.
BIO-FLASH iS.A.registered trademark of Biokit S.A. and QUANTA Flash iS.A.trademark of Inova Diagnostics, Inc. © 2018 Inova Diagnostics, Inc. All rights reserved.
Source: Inova Diagnostics
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