The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) is funded by the US National Institutes of Health and offers clinical evaluation of a TB diagnostic to validate its accuracy and ensure that it is practical for use in the field.
Actiphage is a phage-based diagnostic that can detect active TB disease from a sample of blood. It is to be assessed at a clinical site in the Philippines where patients are being treated for TB. The trials are to see how easy it is to use in a public health laboratory.
The R2D2 TB Network is ideally placed to provide this analysis. It has an extensive network of clinical trial sites, including in Asia (India, Vietnam, the Philippines), Africa (Uganda, South Africa), and Eastern Europe (Georgia), with extensive TB and respiratory disease expertise.
Jane Theaker, CEO of PBD Biotech, says the support of the R2D2 TB Network is invaluable.
“Although TB is a risk worldwide it is particularly prevalent in lower income communities. We want to ensure that Actiphage can fit within current workflows and that the instructions for use are clear and easy to follow in the field.
“R2D2 TB Network provides an independent and transparent process for the assessment of promising TB diagnostics, and we welcome their expertise and feedback.”
The Actiphage kit enables testing of up to 100 people. It will be used to identify viable Mycobacterium tuberculosis (Mtb) in samples of blood from patients attending a clinic for those with suspected TB, but it will not provide a clinical diagnosis. The patients will be assessed and treated according to current protocols.
Adithya Cattamanchi, one of the principal investigators involved with the R2D2 TB Network, comments: “Improved diagnostics for TB are urgently required, especially for children, so we are pleased to be evaluating a novel diagnostic in the community where it is most needed.”
PBD Biotech is one of the diagnostic developers listed on the R2D2 TB Network website, but Actiphage is the only blood test to directly detect live Mycobacterium tuberculosis in the blood.
