Lab21 Partners with Top 10 IVD Player

Lab21 Limited has entered into an agreement with one of the world’s leading diagnostic businesses to develop, manufacture and distribute a diagnostic assay for the detection of Aspergillus species for the partner’s real time PCR platform.

Financial details of the agreement were not disclosed.

Under the agreement Lab21 will use its molecular diagnostic development resource and proprietary intellectual property in the fungal diagnostic area to develop and manufacture the new Aspergillus test as OEM reagents for the partner platform.

Graham Mullis, CEO of Lab21, commented: “We are pleased to enter into a new agreement to develop this assay. The MycAssay™ Aspergillus test provides rapid, accurate clinical information that allows health professionals to make life-saving treatment decisions quickly. This agreement follows closely behind the similar deal made with BD last year.”

Berwyn Clarke, CSO of Lab21, added: “The platform we will be using for the new assay is one which is becoming increasingly well adopted within clinical diagnostic laboratories worldwide. Independent clinical validation studies have already shown that both the new Lab21 Aspergillus and Pneumocystis assays are setting new standards in clinical diagnosis of these clinically important fungal pathogens. We expect the new assays to be significant components of the growing menu of our partner’s molecular diagnostic portfolio.”

Infection caused by Aspergillus is a leading cause of death in immunocompromised patients, with an estimated 10 million people at risk globally each year.

Studies have shown that diagnosis of Aspergillus infection followed by antifungal treatment within the first 10 days of infection reduces mortality from 90 percent to 40 percent - highlighting the need for rapid, accurate testing.

Real-time polymerase chain assays using Lab21 technology have been shown to provide significant advantages in sensitivity and specificity over the current culture techniques.