NEW YORK - Global Access Diagnostics announced on Friday that it has acquired legal manufacturer status rights to a rapid diagnostic test from Bio-Rad Laboratories. The test, called IT-LEISH, is used to diagnose visceral leishmaniasis.
Financial terms of the technology transfer were not disclosed.
Leishmaniasis is transmitted by phlebotomine sand flies and is considered a neglected tropical disease (NTD) that can be fatal if untreated. The IT-LEISH test can help diagnose leishmaniasis using high-performance field-based immuno-chromatography with results in 20 minutes.
In a statement, GADx said the technology will transfer to the Bedford, UK-based firm in order to keep it accessible on the market.
Specifically, GADx will utilize its expertise in lateral flow development and manufacturing to restart the manufacture of IT-LEISH, retaining the same suppliers to offer the product to buyers at an affordable cost, including smaller-scale production batch sizes to meet the needs of neglected tropic disease (NTD) markets.
The test has been independently verified as the most sensitive test available on the market, especially in East African and South American settings, GADx said in a statement.
The firm is a signatory on the Kigali Declaration, which aims in part to mobilize political will to support NTD test development and access.
Mark Davis, CEO of GADx R&D, said the company is "committed to prioritizing the development and manufacture of lateral flow devices for NTDs."
Without the continued manufacture of the IT-LEISH, a World Health Organization roadmap for NTDs would be under threat, Davis said.
"Over the past decade, Bio-Rad has ensured the availability of this rapid test for the detection of antibodies against Leishmania," he also said. "By acquiring the legal manufacturing responsibility for IT-LEISH from Bio-Rad, we are upholding this pledge and keeping a vital test accessible to the market whilst contributing towards the diagnosis and elimination of [visceral leishmaniasis]."
The IT-LEISH test will be available directly from GADx in April 2023.