Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test

PBD Biotech has developed a lyophilized PCR reaction bead for its Actiphage blood test which identifies active tuberculosis (TB).

The new function enables transportation without the need for a cold chain, which reduces the cost associated with shipment and also extends the shelf life for test components. TB treatment and testing must occur close to the point of infection and the update meets these criteria.

Typically, products that contain enzymes are temperature-sensitive and require cold chain transport to ensure their functional integrity. Lyophilization, however, is a water removal system that can be used to extend the life of a product.

PBD Biotech has also established PCR primers and probes that allow specific detection of DNA from mycobacteria TB isolated from a whole blood sample. By enabling early detection of TB disease progression, Actiphage now has the potential to break the cycle of infection, encouraged by the World Health Organization’s (WHO’s) #EndTB initiative.

Jane Theaker, chief executive officer at PBD Biotech, reflected: “Actiphage could also be used to enable the stratification of patients for new TB drugs and vaccine therapies in clinical trials. In this way, the effectiveness of treatments can be assessed much more efficiently, leading to improved targeted drugs and vaccines.

“Antimicrobial resistance is a growing concern for the treatment of TB. Actiphage could be used to monitor the effectiveness of drug treatments, ensuring that, once the infection is cleared from the blood, the drug treatment can be stopped. In this way the potential for antimicrobial resistance can be minimised. This safeguards drug treatments for future use in TB patients.”

Joely Irlam, chief technology officer at PBD Biotech, explained the importance of the new development: “Although lyophilized products for drugs and food aren’t unusual, using this technology for a PCR product is novel. It is expensive and time consuming to redevelop the product in a lyophilized format and to ensure that sensitivity and specificity aren’t compromised.”

She added: “PBD has addressed this pain early doors to ensure the product aligns with the WHO Target Product Profile (TPP) and allows an extension of shelf life, which is always good for the customer.”