SlideShare a Scribd company logo
Bringing sexy back?
biomarkers - useful or useless?
Katrin Hruska
No disclosures
N Engl J Med 2015; 373:1916-1925November 12,
”in the near future, high suPAR levels probably will
inform physician-patient conversations about
preventing kidney disease"
”rigorous NEJM study is a significant breakthrough in preventive
medicine"
Groundbreaking blood test predicts kidney disease
FIVE YEARS BEFORE symptoms appear
”Trisaq's product strategy has been
designed to yield early proof-of-
concept as well as commercialization
opportunities”
”Conservatively estimated, Trisaq's current pipeline
of products can benefit about 15-25% of all CKD
patients and their combined sales potential well
exceeds $1 billion.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Novel Blood Biomarker May Predict CKD Risk
Outcomes studies necessary to prove clinical efficacy
suPAR: Strong and independent predictor of survival
Rather young and
healthy than old and
sick
The primary endpoint was to create an accurate prognostication
score of death by combining APACHE II score and serum suPAR.
💀
14 ng/mL
3-70 ng/mL 1-65 ng/mL
😀
9 ng/mL
suPAR levels and survival in sepsis
range:
Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
suPAR
Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
APACHE II
Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
Mortality%
0
10
20
30
40
i ii iii iv
Apache II<17 Apache II≥17
suPAR
≥12
suPAR
≥12
”validated” in a Swedish cohort
Mortality%
0
10
20
30
40
i ii iii iv
suPAR
≥12
suPAR
≥12
the high mortality in stratum (ii) may be due to small number of patients in
this group (n = 21) and chance variations in mortality. Apart from that
aberration, the findings validate those from the larger Greek study
”validated” in a Swedish cohort
”this strong discriminative prognostic score developed in Greek
patients was validated in a cohort of Swedish patients”
”There is no doubt that suPAR has strong prognostic value in ICU
patients. However, in many cases this knowledge may not lead to
lifesaving interventions, as limited treatment options are efficient
in severely ill sepsis patients”
Prediction of 30 day mortality compared
to Danish Emergency Process Triage
Agreement in 55% of cases
”additional biomarkers other than CT are needed"
”we acknowledge the editorial and statistical contribution of
Leslie S. Prichep, PhD”
”we acknowledge the editorial and
statistical contribution of Leslie S.
Prichep, PhD”
A biomarker is a characteristic that is objectively measured
and evaluated as an indicator of normal biological processes,
pathogenic processes or
pharmacologic responses to a therapeutic intervention
A clinical endpoint is a characteristic or variable that reflects how a patient
feels, functions or survives
A surrogate endpoint is a biomarker that is intended to substitute for a
clinical endpoint
A clinical endpoint is a characteristic or variable that reflects how a patient
feels, functions or survives
A surrogate endpoint is a biomarker that is intended to substitute for a
critical endpoint
Image: Bengt Nyman
SNTF
photo: Michele di Trani
So you think you’re in pain?

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Biomarkers in Emergency Medicine: Katrin Hruska

  • 1. Bringing sexy back? biomarkers - useful or useless? Katrin Hruska
  • 3.
  • 4. N Engl J Med 2015; 373:1916-1925November 12,
  • 5. ”in the near future, high suPAR levels probably will inform physician-patient conversations about preventing kidney disease"
  • 6. ”rigorous NEJM study is a significant breakthrough in preventive medicine"
  • 7.
  • 8. Groundbreaking blood test predicts kidney disease FIVE YEARS BEFORE symptoms appear
  • 9. ”Trisaq's product strategy has been designed to yield early proof-of- concept as well as commercialization opportunities” ”Conservatively estimated, Trisaq's current pipeline of products can benefit about 15-25% of all CKD patients and their combined sales potential well exceeds $1 billion.
  • 10. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
  • 11.
  • 12. Novel Blood Biomarker May Predict CKD Risk Outcomes studies necessary to prove clinical efficacy
  • 13. suPAR: Strong and independent predictor of survival
  • 14.
  • 15.
  • 16. Rather young and healthy than old and sick
  • 17.
  • 18. The primary endpoint was to create an accurate prognostication score of death by combining APACHE II score and serum suPAR.
  • 19. 💀 14 ng/mL 3-70 ng/mL 1-65 ng/mL 😀 9 ng/mL suPAR levels and survival in sepsis range:
  • 20. Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  • 21. suPAR Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  • 23. Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  • 24. Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  • 25. Mortality% 0 10 20 30 40 i ii iii iv Apache II<17 Apache II≥17 suPAR ≥12 suPAR ≥12 ”validated” in a Swedish cohort
  • 26. Mortality% 0 10 20 30 40 i ii iii iv suPAR ≥12 suPAR ≥12 the high mortality in stratum (ii) may be due to small number of patients in this group (n = 21) and chance variations in mortality. Apart from that aberration, the findings validate those from the larger Greek study ”validated” in a Swedish cohort
  • 27. ”this strong discriminative prognostic score developed in Greek patients was validated in a cohort of Swedish patients” ”There is no doubt that suPAR has strong prognostic value in ICU patients. However, in many cases this knowledge may not lead to lifesaving interventions, as limited treatment options are efficient in severely ill sepsis patients”
  • 28. Prediction of 30 day mortality compared to Danish Emergency Process Triage
  • 29.
  • 30. Agreement in 55% of cases ”additional biomarkers other than CT are needed" ”we acknowledge the editorial and statistical contribution of Leslie S. Prichep, PhD”
  • 31. ”we acknowledge the editorial and statistical contribution of Leslie S. Prichep, PhD”
  • 32. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a therapeutic intervention
  • 33. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives A surrogate endpoint is a biomarker that is intended to substitute for a clinical endpoint
  • 34. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives A surrogate endpoint is a biomarker that is intended to substitute for a critical endpoint
  • 36. photo: Michele di Trani So you think you’re in pain?