The studies from our Phase I SBIR (AI082728-01) demonstrated that it is feasible to develop the proposed assay, a biochemiluminescence assay that uses a novel flu virus neuraminidase substrate, for sensitive detection of influenza virus drug resistance. The assay is now being used by a federal agency for monitoring influenza virus drug resistance during the on-going swine flu pandemic. The goal of this Phase II project is to convert the surveillance test into a drug resistance test suitable for point-of-care (POC) use (e.g., in physician's offices), i.e., a test kit that is rapid (<15 min for sample collection to results), simple, sensitive, specific, economic, and easy-to-use. The POC drug resistance test will also have a secondary claim for influenza diagnosis. Thus, the test is a combo test with both flu diagnosis and drug resistance detection functions. Phase II activities include GMP manufacturing, preclinical and clinical studies. The data from the Phase II studies will be submitted to the FDA for clearance of the POC test for both the influenza diagnosis and flu drug resistance detection claims.

Public Health Relevance

Widespread resistance of seasonal influenza H1N1 to Tamiflu, the most commonly used and stockpiled drug, raises serious issue about the effectiveness of Tamiflu stockpiled for pandemic influenza, and posts a challenge for physicians who treat influenza patients. A rapid and sensitive POC flu drug resistance test would promote rational use of the drug, thereby prolonging the effectiveness of a drug, and aid the physicians in making a better prescription decision. There is no such a test available. The primary objective of the proposed Phase II studies is to build on our Phase I efforts and develop a drug resistance test that is suitable for point-of-care use.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI082728-03
Application #
8035936
Study Section
Special Emphasis Panel (ZRG1-IDM-P (12))
Program Officer
Krafft, Amy
Project Start
2010-03-15
Project End
2013-02-28
Budget Start
2011-03-01
Budget End
2013-02-28
Support Year
3
Fiscal Year
2011
Total Cost
$999,992
Indirect Cost
Name
Cellex, Inc.
Department
Type
DUNS #
141314521
City
Rockville
State
MD
Country
United States
Zip Code
20850