In partnership with the Foundation for Innovative New Diagnostics (FIND), we are developing a breakthrough, “game changing” TB diagnostic product called the GBD TB μ-Lab™ POC-F Assay. Because of the design of the assay, as well as the product’s anticipated high sensitivity and specificity, we expect that the product will be useful throughout the TB Diagnostic Health System used worldwide.

This includes in the Peripheral Health Clinic as a true POC capability. Today, a point-of-care product does not exist. The WHO estimates that as many as 60% of TB cases are seen only at the peripheral health clinic, where current diagnosis is impossible. Additionally, because of the extreme ease-of-use and rapidity of the test, along with the very low purchase price relative to existing high technology TB diagnostics, this test will have strong applicability in smear microscopy centers and culture labs. With one product, the company expects to be able to deliver a diagnostic solution to 95% of the market for patient diagnosis.

Regarding the GBD TB μ-Lab™ POC-F Assay product, Dr. Giorgio Roscigno, FIND's Chief Executive Officer has said, “Our collaboration with GBD will hopefully result in a practical tool that can be used by community health workers, allowing them to find TB patients earlier and closer to where they live. This partnership is in line with FIND's mission to develop and implement innovative diagnostics to impact poverty-related diseases and to create effective technologies that respond to patient needs at all levels of the health system."

Expected Product Attributes:

• True Point of Care Application – Rapid, Easy-to-Use and Affordable.
• Equipment – A simple battery operated less than $2,000 USD fluorescent reader will be needed to measure results of the test.
• Preparation – Biosafe preparation of sample.
• Sensitivity – Expected final substrate will have sensitivity similar to culture in both smear +, culture + and smear -, culture + clinical samples.
• Specificity – Expected final substrate will have specificity similar to culture in both smear +, culture + and smear -, culture + clinical samples.
• Time to result – Expected to be less than 30 minute incubation.
• Storage conditions – expected to last in ambient temperatures/conditions for 2+ years.

The GBD TB μ-Lab™ POC-F Assay is not available for sale in the United States of America.