Microbix Biosystems, a life sciences developer, manufacturer, and exporter, is launching a new quality assessment product (QAP) to support molecular diagnostic (MDx) testing for the non-variola orthopoxvirus (Mpox), the cause of Monkeypox.
Microbix chose to create a QAP to support Mpox testing following requests from its customers that provide proficiency-testing and accreditation services to clinical laboratories (i.e., PT or EQA providers) and to prepare for the inclusion of Mpox in standard worldwide genital ulcer disease diagnostic programs. Although the frequency of testing for Mpox is currently limited, labs must become and remain accredited for such testing by PT/EQA providers.
Microbix will be providing Mpox QAPs in liquid or FLOQSwab formats for that PT/EQA need and as a result, its sales are not expected to be correlated to the rates of Mpox infection or with how much this virus is the subject of news media coverage.
In otherwise healthy persons, Mpox infection is usually self-limiting and non-fatal in nature. However, Mpox viral DNA has been detected in human blood, which raises the question of whether blood-borne transmission is a possibility with this emerging pathogen. If blood-borne transmission of Mpox is proven at any future time, the need for routine screening of blood and blood products could arise.
In collaboration with its PT/EQA partners, the Microbix Mpox QAP has now been validated for use across 11 leading MDx testing systems and multiple Lab Developed Tests, at 33 clinical laboratories in multiple European and Scandinavian nations.
The Mpox QAP validation results may be presented by Microbix or its collaborators at a future scientific conference, in accordance with industry practices and standards. PT/EQA shipments of the Mpox QAP can now commence and Microbix expects material sales of this product starting in its current fiscal year.
“Microbix’s Mpox QAPs contain a whole viral genome that includes each primer sequence targeted by leading commercial (IVD) tests and known lab-developed assays,” says Pavel Zhelev, Microbix director of product management. “Our proprietary formulation and consensus genome is thereby targeted to provide lasting support for MDx Mpox tests and future support for extended genital ulcer disease panels including this pathogen, even if this virus continues to mutate at a relatively fast rate.”