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AS A FUNCTION OF ETHYLENE OXIDE STERILIZATION AND STORAGE TIME.

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
2944
Program Year/Program:
1985 / SBIR
Agency Tracking Number:
2944
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
BOSTON BIOTECHNOLOGY CORPORATION
BOSTON BIOTECHNOLOGY CORPORATION 64 GROVE STREET WATERTOWN, MA 02472
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 1985
Title: AS A FUNCTION OF ETHYLENE OXIDE STERILIZATION AND STORAGE TIME.
Agency: HHS
Contract: N/A
Award Amount: $50,000.00
 

Abstract:

AS A FUNCTION OF ETHYLENE OXIDE STERILIZATION AND STORAGE TIME.PRIMARY BILIARY CIRRHOSIS (PBC) IS A DEGENERATIVE LIVER DISEASE OF UNKNOWN ETIOLOGY WHICH FREQUENTLY RESULTS IN DEATH WITHIN 5 TO 10 YEARS OF THE ONSET OF SYMPTOMS. LABORATORY DIAGNOSIS OF PBC IS CURRENTLY BASED UPON HISTOLOGICAL FINDINGS IN BIOPSY MATERIAL AND DETECTION OF SERUM ANTIMITOCHONDRIAL ANTIBODIES (AMA) BY IMMUNOFLUORESCENT STAINING OF UNFIXED TISSUE. AS CURRENTLY PERFORMED, NEITHER PROCEDURE CAN RELIABLY DIFFERENTIATE PBC FROM CHRONIC ACTIVE HEPATITIS OR OTHER AUTOIMMUNE DISORDERS. SINCE AMA ARE PRESENT IN 99% OF PBC SERA AND IN A VERY SMALL PERCENTAGE OF THE GENERAL POPULATION, THE USE OF AMA AS A DIAGNOSTIC CRITERION IS WARRANTED PROVIDED THAT APPROPRIATE LABORATORY TECHNIQUES ARE AVAILABLE. THEREFORE, IT IS PROPOSED THAT AN IMPROVED METHODOLOGY BE DEVELOPED FOR THE DETECTION OF SPECIFIC AMA WHICH ARE PRESENT IN PBC SERA BUT NOT IN CHRONIC LIVER DISEASES OR AUTOIMMUNE DISORDERS. PRELIMINARY RESULTS HAVE IDENTIFIED A MITOCHONDRIAL ANTIGEN WHICH REACTS WITH 90% OF THE PBC SERA TESTED BY IMMUNO BLOT TRANSFER. CROSS-REACTIVITY WITH OTHER CHRONIC LIVER DISEASES WAS LESS THAN 10% UNDER APPROPRIATE ASSAY CONDITIONS. FURTHER PURIFICATION OF THE PBC-SPECIFIC ANTIGEN AND OPTIMIZATION OF THE IMMUNOASSAY PROCEDURES SHOULD PROVIDE A RELIABLE DIAGNOSTIC TECHNIQUE FOR PBC WHICH CAN BE MADE AVAILABLE TO THE

Principal Investigator:

James b. hughes
PRINCIPAL INVESTIGATOR
6177422010

Business Contact:

Small Business Information at Submission:

Boston Biotechnology Corp
20 Staniford Street Boston, MA 02114

EIN/Tax ID:
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No