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Introduction to NASH

Nonalcoholic steatohepatitis (NASH) affects approximately 25 million people in the US1 and it is projected that by 2020, NASH will overtake hepatitis C as the leading cause of liver transplants2. Currently, biopsy is the gold standard for the diagnosis of NASH. However, biopsy may be subject to sampling problems that can confound the results, in addition to surgical costs, risk, and inconvenience for the patient.

Identifying High-Risk NASH Patients is Imperative
  • F3-F4 stage of liver fibrosis has been identified as the most significant independent risk factor for mortality in NASH patients3,4
  • NASH-related cirrhosis is becoming a more common indication for liver transplantation3
  • Progression of NASH-related liver fibrosis is 2 times faster than nonalcoholic fatty liver disease5

PROMETHEUS® FIBROSpect® NASH

Introducing the PROMETHEUS FIBROSpect NASH test that helps detect, stage, and monitor liver fibrosis in nonalcoholic steatohepatitis patients. The simple blood test is noninvasive and provides a quantitative fibrosis score to help physicians risk stratify and monitor patients based on 3 clinically relevant biomarkers.

PROMETHEUS FIBROSpect Biomarkers are Clinically Relevant to Liver Fibrosis Development

New proprietary NASH-specific algorithm

  • Differentiated F0-F2 from F3-F4 liver fibrosis in clinically diagnosed NASH patients9
  • Validated with samples from 396 biopsy-confirmed NASH patients9
  • Provides quantitative liver fibrosis test results
PROMETHEUS FIBROSpect NASH Performance

FIBROSpect NASH benefits:

  • Easy-to-read and interpret test result
  • Noninvasive and nonfasting
  • Can be repeated frequently, easily, and safely
  • May reduce the need for biopsy
PROMETHEUS FIBROSpect NASH Test Results


PROMETHEUS® FIBROSpect® HCV

For hepatitis C (HCV) patients, we offer the PROMETHEUS FIBROSpect HCV test that helps detect, stage, and monitor liver fibrosis. The simple blood test is noninvasive and provides a quantitative fibrosis score to help physicians risk stratify and monitor patients

  • Differentiates between F0-F1 and F2-F4 liver fibrosis9
  • Validated with samples from 348 biopsy-confirmed HCV patients9

PROMETHEUS FIBROSpect HCV Performance
Staging of Liver Fibrosis in HCV Patients is Critical

American Association for Study of Liver Disease (AASLD) and Infectious Disease Society of America (IDSA) 2017 guidelines highlight the benefits of initiating therapy in HCV patients with lower-stage liver fibrosis10:

  • "Initiating therapy in patients with lower-stage fibrosis augments the benefits of SVR [sustained virologic response]"
  • "Treatment delay may decrease the benefit of SVR"

PROMETHEUS FIBROSpect HCV Test Results
Resources:

References:
  1. National Institute of Diabetes and Digestive and Kidney Diseases Web site. Definition & facts of NAFLD & NASH. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts. Accessed August 7, 2017
  2. Canbay A, Sowa JP, Syn WK, Treckman J. NASH cirrhosis – the new burden in liver transplantation: how should it be managed? Visc Med. 2016;32(4):234-238.
  3. Angulo P, Kleiner DE, Dam-Larsen S, et al. Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2015;149(2):389-397.
  4. Ekstedt M, Hagström H, Nasr P, et al. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology. 2015;61(5):1547-1554.
  5. Jayakumar S, Harrison SA, Loomba R. Noninvasive markers of fibrosis and inflammation in nonalcoholic fatty liver disease. Curr Hepatol Rep. 2016;15(2):86-95.
  6. Boeker KH, Haberkorn CI, Michels D, Flemming P, Manns MP, Lichtinghagen R. Diagnostic potential of circulating TIMP-1 and MMP-2 as markers of liver fibrosis in patients with chronic hepatitis C. Clin Chim Acta. 2002;316(1-2):71-81.
  7. Halfon P, Bourlière M, Pénaranda G, et al. Accuracy of hyaluronic acid level for predicting liver fibrosis stages in patients with hepatitis C virus. Comp Hepatol. 2005;4:6.
  8. Ho AS, Cheng CC, Lee SC, et al. Novel biomarkers predict liver fibrosis in hepatitis C patients: alpha 2 macroglobulin, vitamin D binding protein and apolipoprotein AI. J Biomed Sci. 2010;17(58):1-7.
  9. Data on file. Prometheus Laboratories Inc.
  10. When and in whom to initiate HCV therapy. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America Web site. http://www.hcvguidelines.org/evaluate/when-whom. Last updated July 6, 2016. Accessed July 24, 2017.
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