The June 18th meeting of the USFDA Blood Products Advisory Committee focused on the need for a supplemental diagnostic test for HTLV types I and II. Although several commercial Western blot assay (WBA) kits have been approved as supplemental tests for HIV, diagnostic manufacturers have not sought approval of similar devices for HTLV due to low market demand. Representatives from the USFDA and the National Heart, Lung and Blood institute (NHLBI) at the meeting discussed the public health need for such a product and expressed a willingness to fund a commercial entity to develop such a device through SBIR and Orphan Product Program Grants. We plan to develop a WBA kit for HTLV I/II and seek clinical approval of this device. For optimal sensitivity and specificity we will evaluate both purified HTLV I and HTLV II viruses, alone and in combination, as well as purified HTLV envelop and regulatory proteins. We also plan to evaluate several recombinant proteins and synthetic peptides that will allow serological distinction between HTLV type I and HTLV type II infections. Finally, we will establish and scale up manufacturing for this device and seek USFDA approval as a supplemental testing device.
The market for a HTLV supplemental test is estimated to be between $1.5 and $2.5 million in the United States blood banking market. This probably represents half of the total world wide blood donor market. Since there are no other devices approved by the USFDA, nor are there likely to be, we expect to capture essentially all of the U.S. market and a significant share outside the U.S.
