Download - Cardiac biomarkers and lab services
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Cardiac Biomarkers and Services
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• In the US, there are about 50 million troponin, BNP, and other cardiac assays performed annually. At a price of $6 to 25 per test, this equates to a current market of $300 million to $1.25 billion.
• Moreover, if beHer biomarkers were available, market research suggests that an addiKonal 6 ½ million acute and 42 million chronic tests could be done for heart failure discharge and monitoring for decompensaKon and hospital readmission. The resulKng potenKal market would be $40 million to over $1 billion.
© 2013 Winton Gibbons 2
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Ischemic Cluster
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Acute coronary syndrome
Deep vein thrombosis
Ischemic stroke
Pulmonary embolism
Peripheral arterial disease
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CHD S=ll to Top Killer
© 2013 Winton Gibbons 4
179
173
39
42
38
21
255
Heart disease
Cancer
Stroke
Lower respiratory
Injuries
Diabetes
Other
Death rate / 100,000
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Much of the General Popula=on has CHD Risk Factors
© 2013 Winton Gibbons 5
25%
23%
12%
Smoker
High LDL
High blood pressure
No risk
factor, 53%
Some risk
factor, 47%
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Many Firms are Involved, including the Burgeoning Specialty Heart Labs
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Specialty Heart Labs
Atherotech
Aviir
Berkeley Heart Laboratory
Boston Heart Diagnos=cs
CardioDx
Cleveland Heart Laboratory
Health Diagnos=c Laboratory (HDL)
Singulex
Novel biomarker
firms Alere
BG Medicine
BRAHMS
Cri=cal Diagnos=cs
diaDexus
FFA Sciences
LipoSciences
MedTest | Point Scien=fic
Nexus Diagnos=cs
Mainstream
Mainframe diagnos=cs
POC diagnos=cs
Reference laboratories
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Typical Biomarkers -‐ 1
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• Galec=n-‐3 Extra-‐cellular matrix remodeling
• Troponin Myocyte injury and apoptosis
• MPO • oxLDL Oxida=ve stress
• An=-‐oxLDL • An=-‐troponin Autoan=bodies
• GlycoMark® Other
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Typical Biomarkers -‐ 2
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Extra-‐cardiac involvement
• Cysta=n C • NGAL • RDW
Myocyte stress
• (NTpro)BNP • MR-‐proANP • GDF-‐15 • ST2
Neurohormones
• Copep=n • ET-‐1 • MR-‐proADM • UCN-‐1
Inflamma=on
• Adiponec=n • CRP • IL-‐6 • LpPLa2 • PTX3 • TNF-‐a • uFFA
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Genotyping
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Apo E genotype
SLCO1B1 genotype
4q25-‐AF Risk Genotype
9p21 Genotype
CYP2C19 Genotype
KIF6 Genotype
LPA-‐Aspirin Genotype
LPA-‐Intron 25 Genotype
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Mul=-‐marker
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Gene expression
• Corus® CAD
Lipids (cholesterol)
• VAP® Test • HDL Map™ • Cholesterol Balance™
• NMR LipoProfile
• MIRISK®
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There are s=ll Great Biomarker Opportuni=es in Heart Failure
• Worst diagnosis for 30-‐day hospital readmission • 6 million paKents in US have HF • 650 thousand new HF paKents per year • 6.5 million hospital days annually due primarily to HF • 14 million office visits per year due to primarily to HF • 1.3 million hospitalizaKons per year have HF as a primary diagnosis
• 3 million hospitalizaKons per year have HF as a primary or secondary diagnosis
© 2013 Winton Gibbons 11
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Hazard Ra=o of 3 or Greater Required by MDs to Use a Prognos=c HF Assay
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8%#
23%#
35%#
27%#
4%# 4%#
1.5# 2# 3# 4# 6# >6#
Chronic#Hazard#Ra9o#
Es#mated)Required)Hazard)Ra#o)Range)
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Need Objec=ve Measurement to Discharge HF. MDs Willing to Move to a Good Biomarker
© 2013 Winton Gibbons 13
Heart Failure 25% readmission and 11%
death 30-day rates (22% death at 1 year)
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© 2013 Winton Gibbons