Microbix Biosystems Inc. will present results of novel methods to support diagnostic accuracy and whole-process workflow validation of cervical cancer screening tests on self-collected patient specimens. The poster presentation will be made at the 12th European Meeting on Molecular Diagnostics (“EMMD”) taking place in Noordwijk, Netherlands from October 12 to 14, 2022. Ample evidence supports use of self-collected vaginal samples to improve participation in cervical cancer screening programs based on molecular (“MDx”) detection of Human Papilloma Virus (“HPV”).

However, broad adoption of self-collection has been set-back by a lack of materials and methods to evaluate the whole workflow experienced by a specimen – from collection to final diagnostic result. This critical gap is bridged by the current study using Microbix PROCEEDx™FLOQ® simulated positive HPV samples eluted into Copan MSwab® medium – evaluating whether HPV was effectively eluted from the simulated self-collected swabs and then detected by commercial in vitro diagnostic (“IVD”) PCR-based MDx assays. The study determined that three positive specimens simulating infection with high-risk HPV types (16, 18 & 45) and a negative sample were detected and individually identified on six IVD MDx assays: the Abbott Alinity m HPV & Abbott Realtime HPV, Qiagen NeumoDx HPV, Roche cobas 4800 HPV & Roche cobas 6800 HPV, and Seegene Anyplex II HPV28.

Accuracy was 100% across all sample types and assays. The poster will be available on Microbix's website (https://microbix.com) and from EMMD after its presentation. HPV represents a family of over 100 virus sub-types, of which 14 are deemed “high-risk” as they are proven to directly cause cancers, including but not limited to cervical cancer.

Most sexually-active adults become infected with one or more types of HPV and such infections can be persistent. MDx tests permit early detection and guide timely preventative healthcare by identifying those at-risk years before the development of cancers. However, MDx-based screening programs require rigorous workflow design and ongoing validation to ensure their accuracy.

Many healthcare systems now plan to resume the roll-out of MDx-based HPV screening programs that were delayed as a result of the COVID-19 pandemic, important diagnostic healthcare advancements that Microbix is pleased to support with its products and services. Empowering women to collect vaginal samples in private, safe, and convenient locations is expected to promote patient access to healthcare and accelerate the widespread adoption of MDx-based HPV and cervical cancer screening programs. Microbix is proud to be a strategic partner of Copan and help to accelerate the evolution to self-collection by offering HPV-oriented “PROCEED™FLOQ®” (RUO) and prospective “REDx™FLOQ®” (IVD) quality assessment products (QAPs™) worldwide. Purchase enquiries for Microbix's QAPs can be e-mailed to customer.service@microbix.com.