SBIR-STTR Award

Diagnostic Probes to Unique Epitopes on Amylase Isozymes
Award last edited on: 6/4/02

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$550,000
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Michael Patrick Woodward

Company Information

Humagen Fertility Diagnostics Inc (AKA: UNOGEN Inc~Humagen Inc)

2400 Hunters Way
Charlottesville, VA 22911
   (434) 979-4000
   N/A
   N/A
Location: Single
Congr. District: 05
County: Albemarle

Phase I

Contract Number: 1R43CA040860-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
1985
Phase I Amount
$50,000
The ultimate goal of this research is to develop a diagnostic kit which will permit easy and rapid identification of ovarian amylase. This amylase isozyme appears to be a good indicator for ovarian cancer. In addition monoclonal antibodies will be produced which will enable reliable detection of the amounts of salivary, pancreatic, and ovarian amylases in patient specimens. It is anticipated that it will be possible to generate monoclonals which will detect specific isoelectric variants of each isozyme. During Phase I monoclonal antibodies specific for each isoenzyme will be generated. They will form the basis for kit development and clinical testing during Phase II. Such a kit permiting direct evaluation of amylase isozyme levels should prove superior to current methodologies which are either more time consuming or which rely on inhibitors for distinguishing isozymes. At present activity measurements can not distinguish ovarian from salivary isozymes. (2)

Thesaurus Terms:
carbohydrases, amylase, diagnosis, diagnostic tests, design, development and evaluation of diagnostic tests, enzymes, isoenzymes, immunological preparations, monoclonal antibodies, immunological tests and immunoassay, enzyme-linked immunosorbent assay (elisa), neoplasms diagnosis, immunodiagnosis of neoplasms, neoplasms of reproductive system female, ovary neoplasms acids-bases, isoelectric point, biological preparations and standardization, natural products production by genetic manipulation, cell hybrids, hybridomas, diagnostic tests, early diagnosis, immunology, antibody specificity, neoplasms characteristics, proteins of neoplasms, oral-pharyngeal, saliva, pancreas, pancreatic enzymes, reproductive system female, ovary human, tissues, fluids etc. from non-related sources outside immediate project, mammals, rodents, myomorpha, mice (laboratory), tissue (cell) culture

Phase II

Contract Number: 2R44CA040860-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
1987
(last award dollars: 1988)
Phase II Amount
$500,000

Monoclonal antibodies specific for each of the three amylase isoenzymes-salivary, pancreatic, and ovarian-will permit a more accurate assessment of the cause of hyperamylasemia. Current methods for measuring total amylase activity in serum are inadequate, while those for isozyme analysis are either indirect or time consuming.During Phase II, Humagen, Inc. intends to utilize antisalivary-specific and antipancreaticspecific monoclonal antibodies as the basis for a diagnostic kit that will permit the direct determination of serum amylase levels. In brief, immobilized monoclonal antibody will be used to capture the appropriate amylase isoenzyme. DuringPhase II, this kit will be rigorously tested and compared with the Phadebas IsoAmylase kit, which has FDA approval.Elevated serum levels of an ovarian amylase show a good correlation with serous-type ovarian cancer. During Phase II, monoclonal antibodies specific for ovarian amylase will be generated. These antibodies will be used to monitor the amylase activity in serum, cyst tissue, and/or fluid and compared with CA 125 reactivity of patients having ovarian cancer. These monoclonal antibodies will form the basis for a diagnostic kit that can be used to monitor recovery from or recurrence of ovarian cancer.National Cancer Institute (NCI)