Sensitive and Specific Rapid Diagnostic Test for Acute and Chronic Pancreatitis

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$182,430.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK096713-01
Award Id:
n/a
Agency Tracking Number:
R43DK096713
Solicitation Year:
2012
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA11-096
Small Business Information
562 1ST AVE. SOUTH, SUITE 600, SEATTLE, WA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
Y
Duns:
4006628
Principal Investigator:
SYAMALRAYCHAUDHURI
(206) 344-5821
raychaud@inbios.com
Business Contact:
SYAMALRAYCHAUDHURI
(206) 344-5821
raychaud@inbios.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): The very common patient complaint of abdominal pain suggests the diagnosis of pancreatitis. Pancreatitis, however, can be difficult to diagnose or rule out, as the blood-based tests used, serum amylase and lipase, demonstrate suboptimal sensitivity and specificity for acute pancreatitis, and very poor sensitivity and specificity for chronic pancreatitis. Thus pancreatitis often goes undiagnosed until after considerable morbidity has occurred and imaging studies, e.g., computer tomography, are able to detect structural damage. Therefore there is a clear need for a better blood-based test for pancreatitis. Towards developing a novel and robust test for pancreatitis, we have investigated the zymogen granule membrane protein, GP2, as a biomarker for acute and chronic pancreatitis and have developed an ELISA for its detection in patient serum. The major goal of this project is to further enhance the ELISA's performance and develop a rapid point of care test for GP2 that enables the diagnosis of acute or chronic pancreatitis. The major objectives of this proposal are to 1) identif monoclonal antibodies that will improve the GP2 ELISA and form the foundation of a robust point of care rapid test; and 2) determine for the ELISA andrapid test the best materials and reagents that will optimize the test sensitivity and specificity. The ELISA will be simpler to perform and will provide improved test accuracy. The rapid point of care test will greatly enable the diagnostic evaluation ofabdominal pain and pancreatitis in emergency rooms, urgent care clinics and primary care settings throughout the world. PUBLIC HEALTH RELEVANCE: Pancreatic inflammation, both acute and chronic, is a cause of significant morbidity in the United States. Acute pancreatitis is currently diagnosed when appropriate clinical symptoms are present (frequently abdominal pain). Serum amylase and lipase are widely used to diagnose pancreatitis; however, they offer suboptimal sensitivity and specificity for chronic pancreatitis. There is a need for a better blood-based test for pancreatiti. In this application, we have discussed the utility of zymogen granule membrane protein, GP2, as a biomarker for acute and chronic pancreatitis. The major goal of this project is to develop a rapid point of care test for GP2 that enables the diagnosis of acute or chronic pancreatitis. The rapid point of care test will greatly enable the diagnostic evaluation of abdominal pain and pancreatitis in emergency rooms, urgent care clinics and primary care settings throughout the world.

* information listed above is at the time of submission.

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