BIOMARKER (BLOOD TEST) DEVELOPMENT AND COMMERCIALIZATION PLATFORM FOR DISEASE
Background: Blood based nucleated cells such as peripheral blood mononuclear cells (PBMC) comprise immune cells that are known to “crosstalk” with diseased organs. We have shown that PBMC, obtained from animals with solid organ disease of pancreatitis, can provide a “reporter function” to mine for novel biomarkers through microarray technology which can be developed and commercialized into new simple, economical blood tests. These blood test are minimally invasive (vs. biopsy) which can augment or replace conventional testing sensitivity and also provide pre/post drug monitoring responses as a means to personalized medicine. A major application for this technology includes solid organ malignancy. We have recently applied this platform to human solid organ disease of overactive bladder/incontinence such as overactive bladder (OAB):
OAB/incontinence market:
Ø Prevalence of OAB/incontinence ranges from 15-14%, highest in USA
Ø Affects approximately 17-50 million men and women in US
Ø Costs an estimated $60 billion a year to manage in US
Ø One half of the homebound and institutionalized elderly are incontinent
Ø Second-most common reason for the institution of the elderly
Ø Disease is diagnoses by trial and error or invasive and costly urodynamics
Clinical Data: PBMC obtained from OAB patients highlighted 4 new genes/proteins for diagnosing OAB. These genes are involved in structural integrity and can be contributing to bladder muscle laxity and disease severity. Applications to other human solid organ diseases including cancer are in progress.
IP: Application of platform in diagnosis, prognosis, pre/post drug monitoring in (1) urological and (2) solid organ cancer/malignancy – Genome Dynamics International (Drs Bluth and Cheung – cofounders; www.gendyn.us ). 6 patents filed/pending; 1 issued
References:
1. Bluth MH, Lin YY, Zhang H, Viterbo D, Zenilman ME. Gene expression profiles in cells of peripheral blood identify new molecular markers of acute pancreatitis. Archives of Surgery, 2008;143:227-233
2. Cheung WW, Bluth MJ, Johns C, Kahn S, Lin YY, Bluth MH. Peripheral blood mononuclear cell gene array profiles in patients with overactive bladder. Urology 2010;75:896-901
3. Cheung WW, Bluth MJ, Kahn S, Johns C, Bluth MH. Peripheral blood mononuclear cell gene array profiles in female patients with involuntary bladder contractions Advances in Genomics and Genetics 2011;1: 1-5.
Background: Blood based nucleated cells such as peripheral blood mononuclear cells (PBMC) comprise immune cells that are known to “crosstalk” with diseased organs. We have shown that PBMC, obtained from animals with solid organ disease of pancreatitis, can provide a “reporter function” to mine for novel biomarkers through microarray technology which can be developed and commercialized into new simple, economical blood tests. These blood test are minimally invasive (vs. biopsy) which can augment or replace conventional testing sensitivity and also provide pre/post drug monitoring responses as a means to personalized medicine. A major application for this technology includes solid organ malignancy. We have recently applied this platform to human solid organ disease of overactive bladder/incontinence such as overactive bladder (OAB):
OAB/incontinence market:
Ø Prevalence of OAB/incontinence ranges from 15-14%, highest in USA
Ø Affects approximately 17-50 million men and women in US
Ø Costs an estimated $60 billion a year to manage in US
Ø One half of the homebound and institutionalized elderly are incontinent
Ø Second-most common reason for the institution of the elderly
Ø Disease is diagnoses by trial and error or invasive and costly urodynamics
Clinical Data: PBMC obtained from OAB patients highlighted 4 new genes/proteins for diagnosing OAB. These genes are involved in structural integrity and can be contributing to bladder muscle laxity and disease severity. Applications to other human solid organ diseases including cancer are in progress.
IP: Application of platform in diagnosis, prognosis, pre/post drug monitoring in (1) urological and (2) solid organ cancer/malignancy – Genome Dynamics International (Drs Bluth and Cheung – cofounders; www.gendyn.us ). 6 patents filed/pending; 1 issued
References:
1. Bluth MH, Lin YY, Zhang H, Viterbo D, Zenilman ME. Gene expression profiles in cells of peripheral blood identify new molecular markers of acute pancreatitis. Archives of Surgery, 2008;143:227-233
2. Cheung WW, Bluth MJ, Johns C, Kahn S, Lin YY, Bluth MH. Peripheral blood mononuclear cell gene array profiles in patients with overactive bladder. Urology 2010;75:896-901
3. Cheung WW, Bluth MJ, Kahn S, Johns C, Bluth MH. Peripheral blood mononuclear cell gene array profiles in female patients with involuntary bladder contractions Advances in Genomics and Genetics 2011;1: 1-5.
