Point of Care Flu Drug Resistance Test

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,999,981.00
Award Year:
2010
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI082728-02
Award Id:
93399
Agency Tracking Number:
AI082728
Solicitation Year:
n/a
Solicitation Topic Code:
NIAID
Solicitation Number:
n/a
Small Business Information
CELLEX, INC., 9700 GREAT SENECA HWY, STE 174, ROCKVILLE, MD, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
141314521
Principal Investigator:
XINGXIANGLI
(301) 947-0202
LIX@CELLEXINC.COM
Business Contact:
() -
wtx@cellexinc.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): 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 o f 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 res istance test suitable for point-of-care (POC) use (e.g., in physician's offices), i.e., a test kit that is rapid (lt 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 st udies 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 us e 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.

* information listed above is at the time of submission.

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