SBIR-STTR Award

Human T-cell leukemia virus I (HTLV-1) is a transforming retrovirus etiologically associated with adult T-c-ell leukemia/lymphoma and tropical spastic paraparesis. The number of HTLV-I seropositive blood donors in the United States is becoming alarmingly high, raising concerns about contamination of transfistable blood products. Development of a highly sensitive and highly specific bloodscreening assay for HTLV-I antibodies in serum has been hindered by limiting quantities of certain viral proteins, including the most immunogenic, which is envelope protein.The Phase I study outlines a strategy for expressing selected proteins, as well as the entire envelope protein, using synthetic DNA coding sequences. It is anticipated that this approach will allow these polypeptides to be expressed at high levels in E. coli. The expressed polypeptides will be analyzed biochemically and evaluated for their ability to detect antibodies to HTLV-I in human sera.In Phase II, promising candidate envelope polypeptides will be used to configure an enzyme-linked immunoassay (EIA) to detect antibodies to HTLV-1 in human sera. The EIA will be evaluated for sensitivity and specificity using sera from a large number of normal and infected individuals. It is envisaged that a complementary set of recombinant-derived HTLV-I proteins will be configured into a high-quality blood-screening assay for exposure to this virus.

Anticipated Results:
It is believed that an accurate, cost-effective blood-screening assay for exposure to HTLV-I will be used in a wide variety of settings. Major markets include screening of transfusable products by blood banks and clinical screening by the armed services, hospitals, sexually transmitted disease clinics, drug abuse clinics, and public and private laboratories.National Cancer Institute