SBIR-STTR Award

Rapid OIA For Detection of Chlamydia And Gonorrhea
Award last edited on: 12/2/02

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$571,081
Award Phase
2
Solicitation Topic Code
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Principal Investigator
James E Maynard

Company Information

Thermo BioStar Inc (AKA: Bio-Star Medical Products Inc~Biostar Inc)

6655 Lookout Road
Boulder, CO 80301
   (800) 637-3717
   N/A
   www.thermo.com
Location: Single
Congr. District: 02
County: Boulder

Phase I

Contract Number: 1R44AI041939-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
1997
Phase I Amount
$100,000
The goal of this project is to successfully develop and commercialize a simple, rapid, point of care test for the combined detection of chlamydia and gonorrhea from a single endocervical or male urethral swab sample. With this combined test, a physician will be capable of diagnosing chlamydia, gonorrhea, or co-infections and providing appropriate treatment at the time of a patient s first visit to the clinic. This will eliminate the need for subsequent patient contact to inform the test results and/or prescribe appropriate therapy. In Phase I on this project, BioStar, in collaboration with Dr. Edward Hook at the University of Alabama School of Medicine and Dr. Ellena Peterson at the University of California, Irvine, will conclude feasibility on the development of an assay for the detection of Neisseria gonorrhea. Feasibility will also be demonstrated for combining BioStar's current chlamydia assay with the assay for gonorrhea. The combined test will be developed using BioStar s patented Optical Immuno-Assay technology (OIA). Phase II of this project will focus on final optimization of the combined test and will bring the test through full development including assay transfer to manufacturing, scale-up of production, and conducting clinical trials for assay validation and FDA 510K submission.

Phase II

Contract Number: 4R44AI041939-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
1998
Phase II Amount
$471,081
The goal of this project is to successfully develop and commercialize a simple, rapid, point of care test for the combined detection of chlamydia and gonorrhea from a single endocervical or male urethral swab sample. With this combined test, a physician will be capable of diagnosing chlamydia, gonorrhea, or co-infections and providing appropriate treatment at the time of a patient s first visit to the clinic. This will eliminate the need for subsequent patient contact to inform the test results and/or prescribe appropriate therapy. In Phase I on this project, BioStar, in collaboration with Dr. Edward Hook at the University of Alabama School of Medicine and Dr. Ellena Peterson at the University of California, Irvine, will conclude feasibility on the development of an assay for the detection of Neisseria gonorrhea. Feasibility will also be demonstrated for combining BioStar's current chlamydia assay with the assay for gonorrhea. The combined test will be developed using BioStar s patented Optical Immuno-Assay technology (OIA). Phase II of this project will focus on final optimization of the combined test and will bring the test through full development including assay transfer to manufacturing, scale-up of production, and conducting clinical trials for assay validation and FDA 510K submission.