critical diagnostics introducing the aspect plus™ st2 test
TRANSCRIPT
Introducing the Aspect-PLUS™ ST2 Test
James V. Snider, Ph.D.PresidentCritical Diagnostics
Heart Failure 2015
Why produce a FAST assay for ST2?
• Using the 1st generation ELISA many things were accomplished
• ST2 is CE marked for sale in the EU and is cleared by the US FDA, CFDA and KFDA as an aid in risk stratification of patients with heart failure.
• Included in the 2013 ACCF/AHA guidelines for heart failure patient management.
• In 2014 the AMA issued a unique CPT code for ST2, 83006, and in January 2015 CMS issued a favorable coverage/payment decision.
• April 2015 the AJC published the International ST2 Consensus Panel paper summarizing the clinical value of ST2. – Twelve chapters and over 80 pages summarizing the support for
clinical use of ST2 across all 4 stages of heart failure.
ST2 Clinical Value• In published research studies ST2 is
consistently the most robust prognostic marker reported
• With its low RCV it is ideally suited for patient monitoring
• ST2 is not adversely effected by typical confounders such as renal dysfunction and obesity
• Emerging evidence shows the utility of using ST2 to personalize patient therapy
Serial ST2 Measurements: Basel ADHF Cohort
Breidhardt, et al. 2013, J. Card. Failure
ST2 Predicts Therapy ResponseCu
mul
ativ
e su
rviv
al
Days
BB treated ST2 responder
untreated ST2 responderuntreated ST2 non-responder
BB treated ST2 non-responder
p=0.62p=0.1
• Risk is not absolute! • It can be attenuated!!
Breidhardt, et al. 2013, J. Card. Failure
RR=2.8
ST2 Therapeutic Response:PROTECT Study
Non- Rarely Mostly Full
CV events by ST2 time in response
% time in response
% w
ith C
V ev
ents
0.0
0.2
0.4
0.6
0.8
1.0
Non-responderRarely responderMostly responderFull responder
N=46 N=28 N=30 N=41
Summary: • Time in ST2 response (<35
ng/ml) is closely tied to outcomes in chronic HF due to LVSD.
• The prognostic value of sST2 is independent of relevant covariates, including NT-proBNP.
• “Only sST2 appeared to provide incremental prognostic information and reflect changes in myocardial remodeling over time.”
Gaggin et al. 2014, JACC HF
Cardiovascular events by baseline sST2 and final achieved β-blocker (BB) dose
Gaggin H et al. Circ Heart Fail 2013;6:1206-1213 Copyright © American Heart Association, Inc. All rights reserved.
p = 0.09
P < 0.001
for trend
Stage B NYHA Class I HF ProgressionBiomarker Levels and Therapy in Subsequent Visits
1 2 3 4 5 6 70
10
20
30
40
50
60
70
80
90
0
100
200
300
400
500
600
700
800
900S T
2 (n
g/m
L)
NT-
pro B
NP
(pg/
mL)
β blocker increased
β blocker increased
ACE-inhibitorincreased
Visits
Aspect-PLUS™ ST2 Test• Quantitative
fluorescent lateral flow immunoassay format
• System is comprised of a disposable, single use cassette and a fluorescent reader
• Uses EDTA plasma as the test specimen
• Result in 20 minutes• Analytical performance
comparable to the Presage® ST2 Assay
Aspect-PLUS™ ST2 Test: Performance
Parameter Presage® ST2 Assay Aspect-PLUS™ ST2 TestLimit of Quantitation (LoQ) 2.4 ng/ml 12.5 ng/ml
Linearity Limit 200 ng/ml 257 ng/ml
Intra-Assay Precision 4.0% 10.4%
Inter-Assay Precision 6.4% 13.6%
Hook Effect No hook effect up to 200 ng/ml No hook effect up to 2000 ng/ml
Interfering SubstancesNo effect observed from 5 endogenous and 49 therapeutic
substances
Specimen EDTA or heparin plasma, serum EDTA plasma
Specimen volume 0.020 ml 0.035 ml
Method Concordance: Passing-Bablok regression
No significant deviation from linearity (y = 1.01x + 5.8, p=0.75, ). And a correlation coefficient (R) of 0.92.
Conclusions• ST2 is established as a powerful biomarker
tool for personalization and optimization of heart failure patient care
• The Aspect-PLUS™ ST2 Test is the first rapid test providing a cost effective solution for ST2 testing
• The Aspect-PLUS™ ST2 Test is comparable to the established Presage® ST2 Assay and meets the requirements for IVD analytical performance.