SBIR-STTR Award

A Rapid Diagnostic Test for Bacterial Vaginosis
Award last edited on: 3/2/07

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$816,326
Award Phase
2
Solicitation Topic Code
865
Principal Investigator
Stephen Johnson

Company Information

Ibbex Inc (AKA: Ibbex Pharmaceutials)

2800 Milan Court Suite 373
Birmingham, AL 35211
   N/A
   ibbex@oadi.uab.edu
   N/A
Location: Single
Congr. District: 07
County: Jefferson

Phase I

Contract Number: 1R43HD036964-01
Start Date: 9/30/98    Completed: 3/31/99
Phase I year
1998
Phase I Amount
$100,000
The long term goal of this project is to develop an effective and rapid diagnostic test for bacterial vaginosis which affects about 35% women in reproduction age. This test is based on the fact that a consistently elevated level of sialidase activity was observed in the vaginal samples of women who had bacterial vaginosis. The specific aims for this period are: l, synthesis of suitable chromogenic substrates of bacterial sialidase. 2, demonstration of that a visible change of color is possible when these compounds are used as the substrate of sialidase. Based on the results of previous studies, effective treatment of bacterial vaginosis in pregnant women reduces premature labor and premature delivery by 50%. The new test developed from this proposal will significantly help physicians to correctly and rapidly diagnose the disease, which is believed to be underdiagnosed currently due to limitations of available methods. PROPOSED COMMERCIAL APPLICATIONS: This new diagnostic test will help physicians to correctly and rapidly diagnose the common disease, bacterial vaginosis. Data proved that effective treatment of bacterial vaginosis reduces prematurity by 50%.

Thesaurus Terms:
bacterial disease, diagnosis design /evaluation, diagnostic test, enzyme substrate, exo alpha sialidase, vagina disorder chemical synthesis, communicable disease diagnosis, early diagnosis, genital secretion, premature labor, rapid diagnosis colorimetry, women's healthNATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

Phase II

Contract Number: 2R44HD036964-02A1
Start Date: 6/1/00    Completed: 5/31/02
Phase II year
2000
(last award dollars: 2001)
Phase II Amount
$716,326

The long-term goal of this project is to develop an effective and rapid diagnostic test for bacterial vaginosis which infects about 35% of women. This test is based on the fact that consistently elevated levels of sialidase enzyme was observed in the vaginal samples of women who had bacterial vaginosis. The specific aims for this period include: (1) analytical studies on synthetic chromogenic substrates using pure stock-culture aerobic and anaerobic isolates, (2) pre-clinical trials on synthetic chromogenic substrate compounds using patient vaginal fluid samples, (3) scale-up synthesis of the most promising compound, (4) develop a packaging format for the product, (5) conduct a planned human clinical trial, and (6) file 510(k) application with the US FDA. Based on the results of previous studies, effective treatment of bacterial vaginosis in pregnant women reduces preterm labor and preterm delivery by 50%. The new test developed from this technology will significantly aid physicians in correctly and rapidly diagnosing bacterial vaginosis, which is believed to be under diagnosed due to limitations of available methods. PROPOSED COMMERCIAL APPLICATION: This new diagnostic test will aid physicians to correctly and rapidly diagnose the common disease, bacterial vaginosis. Published data has shown that effective treatment of diagnosed cases of bacterial vaginosis reduces the incidence of preterm birth by 50%.