AKONNI BIOSYSTEMS INC — Department of Health and Human Services SBIR Phase II: NIAID
AKONNI BIOSYSTEMS INC — SBIR Phase II award from Department of Health and Human Services.
- Amount
- $2,999,954
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Topic
- NIAID
- NAICS
- —
- Place of performance
- MD
- Period
- —
Description
Nucleic acid testing offers the potential to improve tuberculosis diagnosis world wideHigh purity DNA is essential to the success of virtually any downstream nucleic acid detection methodWe propose to develop a sample preparation system to extract and purify Mycobacterium tuberculosis DNA from raw sputumThe project goalas described in the solicitationPHSTopicis to develop an inexpensive and easy to use sputum processing system that can operate in a low resource clinic setting for downstream molecular testingWe plan to meet the following objectives over the course of this projectStreamline the workflow to improve the ease of use and meet the intended use settingDesign and produce the device and consumables under Design Control using good manufacturing processes to meet ISOrequirementsVerify the device function relative to its product requirementsValidate the device with raw sputum specimens using a PCR MTB test to determine the clinical sensitivity and specificity as compared to a standard laboratory methodandImplement a Quality Program for the sample preparation device to ensure lot to lot consistency