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Cardiac	
  Biomarkers	
  and	
  Services	
  
•  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	
  
Ischemic	
  Cluster	
  
Acute	
  
coronary	
  
syndrome	
  
Peripheral	
  
arterial	
  
disease	
  

Deep	
  vein	
  
thrombosis	
  

Pulmonary	
  
embolism	
  

Ischemic	
  
stroke	
  
©	
  2013	
  Winton	
  Gibbons	
  

3	
  
CHD	
  S=ll	
  to	
  Top	
  Killer	
  
Death	
  rate	
  /	
  100,000	
  
Heart	
  disease	
  

	
  179	
  	
  

Cancer	
  

	
  173	
  	
  

Stroke	
   	
  39	
  	
  
Lower	
  respiratory	
   	
  42	
  	
  
Injuries	
   	
  38	
  	
  
Diabetes	
   	
  21	
  	
  
Other	
  

	
  255	
  	
  
©	
  2013	
  Winton	
  Gibbons	
  

4	
  
Much	
  of	
  the	
  General	
  Popula=on	
  has	
  CHD	
  Risk	
  
Factors	
  

Smoker	
  
High	
  LDL	
  
High	
  blood	
  
pressure	
  

25%	
  
23%	
  

Some	
  
risk	
  
factor,	
  
47%	
  

No	
  
risk	
  
factor,	
  
53%	
  

12%	
  

©	
  2013	
  Winton	
  Gibbons	
  

5	
  
Many	
  Firms	
  are	
  Involved,	
  including	
  the	
  
Burgeoning	
  Specialty	
  Heart	
  Labs	
  
Specialty	
  
Heart	
  Labs	
  

Novel	
  
biomarker	
  
firms	
  

Atherotech	
  

Alere	
  

Aviir	
  
Berkeley	
  Heart	
  Laboratory	
  
Boston	
  Heart	
  Diagnos=cs	
  

BG	
  Medicine	
  

Cleveland	
  Heart	
  Laboratory	
  

Mainframe	
  diagnos=cs	
  

BRAHMS	
  
Cri=cal	
  Diagnos=cs	
  
diaDexus	
  

CardioDx	
  

Mainstream	
  

POC	
  diagnos=cs	
  

FFA	
  Sciences	
  
LipoSciences	
  

Health	
  Diagnos=c	
  
Laboratory	
  (HDL)	
  

MedTest	
  |	
  Point	
  Scien=fic	
  

Singulex	
  

Nexus	
  Diagnos=cs	
  

©	
  2013	
  Winton	
  Gibbons	
  

Reference	
  laboratories	
  

6	
  
Typical	
  Biomarkers	
  -­‐	
  1	
  
Extra-­‐cellular	
  matrix	
  
remodeling	
  

•  Galec=n-­‐3	
  

Myocyte	
  injury	
  and	
  
apoptosis	
  

•  Troponin	
  

Oxida=ve	
  stress	
  

•  MPO	
  
•  oxLDL	
  

Autoan=bodies	
  

•  An=-­‐oxLDL	
  
•  An=-­‐troponin	
  

Other	
  

•  GlycoMark®	
  
©	
  2013	
  Winton	
  Gibbons	
  

7	
  
Typical	
  Biomarkers	
  -­‐	
  2	
  
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	
  

©	
  2013	
  Winton	
  Gibbons	
  

Inflamma=on	
  
•  Adiponec=n	
  
•  CRP	
  
•  IL-­‐6	
  
•  LpPLa2	
  
•  PTX3	
  
•  TNF-­‐a	
  
•  uFFA	
  

8	
  
Genotyping	
  
Apo	
  E	
  genotype	
  
SLCO1B1	
  genotype	
  
4q25-­‐AF	
  Risk	
  Genotype	
  
9p21	
  Genotype	
  
CYP2C19	
  Genotype	
  
KIF6	
  Genotype	
  
LPA-­‐Aspirin	
  Genotype	
  
LPA-­‐Intron	
  25	
  Genotype	
  
©	
  2013	
  Winton	
  Gibbons	
  

9	
  
Mul=-­‐marker	
  
Gene	
  
expression	
  

Lipids	
  
(cholesterol)	
  

• Corus®	
  CAD	
  

• VAP®	
  Test	
  
• HDL	
  Map™	
  
• Cholesterol	
  
Balance™	
  
• NMR	
  
LipoProfile	
  
• MIRISK®	
  

©	
  2013	
  Winton	
  Gibbons	
  

10	
  
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	
  
Hazard	
  Ra=o	
  of	
  3	
  or	
  Greater	
  Required	
  by	
  MDs	
  
to	
  Use	
  a	
  Prognos=c	
  HF	
  Assay	
  
Chronic#Hazard#Ra9o#

Es#mated)Required)
Hazard)Ra#o)Range)

35%#
27%#
23%#

8%#
4%#
1.5#

2#

3#

4#

©	
  2013	
  Winton	
  Gibbons	
  

4%#

6#

>6#

12	
  
Need	
  Objec=ve	
  Measurement	
  to	
  Discharge	
  HF.	
  
MDs	
  Willing	
  to	
  Move	
  to	
  a	
  Good	
  Biomarker	
  

Heart Failure 25%
readmission and 11%
death 30-day rates	
  
(22%	
  death	
  at	
  1	
  year)

©	
  2013	
  Winton	
  Gibbons	
  

13	
  
•  Blog	
  
–  hHp://www.wingibbons.wordpress.com	
  

•  LinkedIn	
  
–  hHp://www.linkedin.com/in/wintongibbons/	
  

•  SlideShare	
  
–  hHp://www.slideshare.net/wingibbons	
  

•  TwiHer	
  
–  @wingibbons	
  
©	
  2013	
  Winton	
  Gibbons	
  

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Cardiac biomarkers and lab services

  • 2. •  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  
  • 3. Ischemic  Cluster   Acute   coronary   syndrome   Peripheral   arterial   disease   Deep  vein   thrombosis   Pulmonary   embolism   Ischemic   stroke   ©  2013  Winton  Gibbons   3  
  • 4. CHD  S=ll  to  Top  Killer   Death  rate  /  100,000   Heart  disease    179     Cancer    173     Stroke    39     Lower  respiratory    42     Injuries    38     Diabetes    21     Other    255     ©  2013  Winton  Gibbons   4  
  • 5. Much  of  the  General  Popula=on  has  CHD  Risk   Factors   Smoker   High  LDL   High  blood   pressure   25%   23%   Some   risk   factor,   47%   No   risk   factor,   53%   12%   ©  2013  Winton  Gibbons   5  
  • 6. Many  Firms  are  Involved,  including  the   Burgeoning  Specialty  Heart  Labs   Specialty   Heart  Labs   Novel   biomarker   firms   Atherotech   Alere   Aviir   Berkeley  Heart  Laboratory   Boston  Heart  Diagnos=cs   BG  Medicine   Cleveland  Heart  Laboratory   Mainframe  diagnos=cs   BRAHMS   Cri=cal  Diagnos=cs   diaDexus   CardioDx   Mainstream   POC  diagnos=cs   FFA  Sciences   LipoSciences   Health  Diagnos=c   Laboratory  (HDL)   MedTest  |  Point  Scien=fic   Singulex   Nexus  Diagnos=cs   ©  2013  Winton  Gibbons   Reference  laboratories   6  
  • 7. Typical  Biomarkers  -­‐  1   Extra-­‐cellular  matrix   remodeling   •  Galec=n-­‐3   Myocyte  injury  and   apoptosis   •  Troponin   Oxida=ve  stress   •  MPO   •  oxLDL   Autoan=bodies   •  An=-­‐oxLDL   •  An=-­‐troponin   Other   •  GlycoMark®   ©  2013  Winton  Gibbons   7  
  • 8. Typical  Biomarkers  -­‐  2   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   ©  2013  Winton  Gibbons   Inflamma=on   •  Adiponec=n   •  CRP   •  IL-­‐6   •  LpPLa2   •  PTX3   •  TNF-­‐a   •  uFFA   8  
  • 9. Genotyping   Apo  E  genotype   SLCO1B1  genotype   4q25-­‐AF  Risk  Genotype   9p21  Genotype   CYP2C19  Genotype   KIF6  Genotype   LPA-­‐Aspirin  Genotype   LPA-­‐Intron  25  Genotype   ©  2013  Winton  Gibbons   9  
  • 10. Mul=-­‐marker   Gene   expression   Lipids   (cholesterol)   • Corus®  CAD   • VAP®  Test   • HDL  Map™   • Cholesterol   Balance™   • NMR   LipoProfile   • MIRISK®   ©  2013  Winton  Gibbons   10  
  • 11. 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  
  • 12. Hazard  Ra=o  of  3  or  Greater  Required  by  MDs   to  Use  a  Prognos=c  HF  Assay   Chronic#Hazard#Ra9o# Es#mated)Required) Hazard)Ra#o)Range) 35%# 27%# 23%# 8%# 4%# 1.5# 2# 3# 4# ©  2013  Winton  Gibbons   4%# 6# >6# 12  
  • 13. Need  Objec=ve  Measurement  to  Discharge  HF.   MDs  Willing  to  Move  to  a  Good  Biomarker   Heart Failure 25% readmission and 11% death 30-day rates   (22%  death  at  1  year) ©  2013  Winton  Gibbons   13  
  • 14. •  Blog   –  hHp://www.wingibbons.wordpress.com   •  LinkedIn   –  hHp://www.linkedin.com/in/wintongibbons/   •  SlideShare   –  hHp://www.slideshare.net/wingibbons   •  TwiHer   –  @wingibbons   ©  2013  Winton  Gibbons