Significant Progress in Sepsis Testing Industry in 2017

ROCKVILLE, Md., March 30, 2017 /PRNewswire/ -- Market research firm Kalorama Information notes two big developments in sepsis detection and diagnosis last month. The firm, which has a specialty in IVD markets and life science markets, said that a new qPCR test and a PCT biomarker test were cleared and use- expanded, respectively. Sepsis is, unfortunately, a highly lethal disease but early detection improves outcomes, thus the interest in these tests, according to the firm. Kalorama Information's World Market for Molecular Diagnostics report provides markets for infectious disease-based molecular tests, including sepsis. 

Sepsis is not an infection, but rather a complication that that is caused by the body's overwhelming response to an infection. This overwhelming immune response can damage tissues and organs throughout the body, potentially leading to multiple organ failure and death. The Centers for Disease Control and Prevention (CDC) has reported that during 2004 to 2009, the annual range of published sepsis-related mortality estimates based on administrative codes is 168,000–381,000), while annual estimates generated using death certificates for 2004-2009 is 146,000–159,000. The National Institute of General Medical Sciences (National Institutes of Health) reports that more than a million Americans develop severe sepsis each year, and that it has been estimated that 28% to 50% of people with severe sepsis die. 

"The development of tests for identification of pathogens that that cause blood stream infections is another rapidly growing field," said Bruce Carlson, Publisher of Kalorama Information. 

In February 2017, Immunexpress announced that it had received 510(k) clearance from the FDA for use of SeptiCyte™ LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of ICU admission. The announcement also reported that SeptiCyte™ LAB is the first RNA-based clinical diagnostic tool, direct from whole blood, to aid medical providers in the early identification of infection in suspected sepsis patients. SeptiCyte™ LAB is a reverse transcription quantitative PCR test that measures RNA transcripts of four immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8. The test is FDA cleared for use as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of ICU admission.

Also in February 2017, the FDA announced that it had cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis PCT is a biomarker that has been used for many years in the diagnosis of sepsis. In February 2017, the FDA announced that it had cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, and stopped in patients with sepsis. The press release also reported that the Vidas Brahms PCT Assay is the first test to use procalcitonin as a biomarker to help make antibiotic management decisions in patients with these conditions. The Vidas Brahms PCT Assay is marketed by bioMérieux.   

Several companies are developing and/or market molecular diagnostic tests for identification of pathogens involved in bloodstream infections. Some of these tests also include antibiotic resistance genes. These companies include: 

• BioFire Diagnostics (a bioMérieux Company) – FilmArray® Blood Culture Identification (BCID) Panel, which includes 24 gram positive, gram negative and yeast pathogens and 3 antibiotic resistance genes associated with bloodstream infections (on the market)
• Bruker Corporation: IVD MALDI Sepsityper kit – For the rapid identification of microorganisms from positive blood culture bottles; Based on mass spectrometry technology (CE marked)
• Cube Dx GmbH: Early Pathogen ID; Integrated Sepsis Diagnostics -qPCR followed by hybcell (cylindrical microarray) [4 hour test]
• Curetis: Unyvero BCU Cartridge - For blood culture; For detection of up to 103 analytes (on the market in Europe)
• GenMark Diagnostics: Pipeline includes Blood Culture Identification Gram-Positive Panel, Blood Culture Identification Gram-Negative Panel, and Blood Culture Identification Fungal Pathogen Panel
• T2 Biosystems: T2Bacterial Panel – Rapid detection panel for bacterial sepsis; identifies the species-specific source of bacterial infection. (In development; FDA filing planned for mid-2017.)

Kalorama Information's seventh edition of its Molecular Diagnostic report can be found at: https://www.kaloramainformation.com/Molecular-Diagnostics-Edition-10595682/

More of Kalorama's diagnostics market reports can be found at: https://www.kaloramainformation.com/diagnostics-market-c1125/. 

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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Press Contact:                                          
Bruce Carlson
212 807 2262
[email protected]

SOURCE Kalorama Information

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