NASA SBIR 2008 Solicitation


PROPOSAL NUMBER: 08-1 X10.01-9543
SUBTOPIC TITLE: In Flight Diagnosis and Treatment
PROPOSAL TITLE: Thioaptamer Diagnostic System

SMALL BUSINESS CONCERN (Firm Name, Mail Address, City/State/Zip, Phone)
AM Biotechnologies, LLC
6023 Avenue S, #228
Galveston, TX 77551 - 5419
(409) 771-1981

PRINCIPAL INVESTIGATOR/PROJECT MANAGER (Name, E-mail, Mail Address, City/State/Zip, Phone)
Xianbin Yang
6023 Ave S, #228
Galveston, TX 77551 - 5419
(832) 858-8779

Expected Technology Readiness Level (TRL) upon completion of contract: 4 to 5

TECHNICAL ABSTRACT (Limit 2000 characters, approximately 200 words)
AM Biotechnologies (AM) will develop a diagnostic system in response to SBIR Topic X10.01 Reusable Diagnostic Lab Technology that will simultaneously detect and quantify numerous protein biomarkers with excellent sensitivity. AM will enhance the current clinical gold standard immunoassay methodology by using its proprietary bead-based aptamer selection process to select dithiophosphate backbone-modified (PS2) "thio" aptamers (PS2-thioaptamers) as replacements for antibodies in immunoassays. The PS2-thioaptamers are binding agents with functionality comparable to antibodies but with very long shelf-life under ambient environment storage. The PS2-thioaptamers bind much more tightly to their targets than regular aptamers without sacrificing specificity, and are much more nuclease resistant. AM's bead-based process allows fast selection and identification of PS2-thioaptamers, which cannot be directly selected using older aptamer technologies such as Systematic Evolution of Ligands by Exponential Enrichment (SELEX). AM will demonstrate PS2-thioaptamer integration into a state-of-the-art microfluidics instrument from Sandia National Laboratory that meets NASA's form factor needs for space flight. The Phase I Project will demonstrate detection and quantification of osteocalcin (OC) using a PS2-thioaptamer in a prototype microfluidics device (TRL-4). Phase II will entail completing the panel of biomarkers for bone demineralization and delivering a prototype of the system to NASA. In Phase III, AM and Sandia will deliver a flight test system to NASA and begin FDA validation of the system for potential use in clinical diagnostics of osteoporosis as well as other conditions.

POTENTIAL NASA COMMERCIAL APPLICATIONS (Limit 1500 characters, approximately 150 words)
The combination of AM's proprietary PS2-thioaptamers with the microfluidics technology from Sandia National Laboratory will result in a biomarker diagnostic system that is compatible with long duration spaceflight. The PS2-thioaptamers offer performance comparable to antibodies but have a very long shelf life and can be stored in ambient conditions. The Sandia microfluidics instrument is very sensitive (fM detection limit), small, low mass, easy to operate and draws little power. The combination of these two technologies would result in a flight system that would enable NASA to easily detect and quantify numerous biomarkers simultaneously during long duration missions and would also enable AM to develop for NASA clinical diagnostic assays for many conditions of interest. The stage of development of these technologies as well as the use of proven clinical diagnostic immunoassay methodologies enables AM to develop and deliver a flight test system quickly for near-term NASA flight research into many conditions of interest.

POTENTIAL NON-NASA COMMERCIAL APPLICATIONS (Limit 1500 characters, approximately 150 words)
A PS2-thioaptamer assay for potentially any condition that has FDA-approved biomarkers could be developed and integrated into the microfluidics instrument, which provides significant clinical diagnostic market commercialization potential. The PS2-thioaptamer binding agents could also be used in almost any detection/quantification technology thus opening the possibility of faster diagnostic market commercialization using currently approved instrument hardware. Prior to FDA-approved diagnostic applications, the PS2-thioaptamers could readily be used in a manner similar to antibodies for life science research. Additionally, since the PS2-thioaptamers are very nuclease resistant, it is possible that the same binding agents selected for diagnostic/research use could also be used effectively as therapeutics.

NASA's technology taxonomy has been developed by the SBIR-STTR program to disseminate awareness of proposed and awarded R/R&D in the agency. It is a listing of over 100 technologies, sorted into broad categories, of interest to NASA.

Biomedical and Life Support
Biomolecular Sensors

Form Generated on 11-24-08 11:56