Australian molecular diagnostics company Genera Biosystems Limited (ASX:GBI) and automation and flow cytometry specialist Beckman Coulter Life Sciences have agreed to enter into a co-marketing partnership.
Matthew Grigg, Commercial Director of Beckman Coulter, Australia, New Zealand and Rest of Asia said the commercial partnership brings together the power and capabilities of high content flow cytometry, liquid handling automation and high multiplex MDx testing in a single streamlined workflow.
As part of the agreement, Beckman Coulter will provide integrated flow cytometry based upon CytoFLEXTM technology to its next generation automation system – the BiomekTM i-Series platform. The system will empower scaled up throughput for multiplex AmpaSand MDx assays supplied by Genera.
“A key objective of pathology laboratories is to improve workflow and lab throughput capacity. This partnership will enable Genera’s single-well AmpaSand MDx assays to meet the needs of pathology laboratories in Australia first and followed by an expansion into other countries. These integrated solutions incorporate Beckman Coulter’s technical instrumentation excellence,” Mr Grigg said.
Genera’s PapType, an ARTG listed and CE-marked MDx test, simultaneously detects and identifies 14 high-risk types of HPV and 2 low risk HPV types in a single-well. These high-risk HPV types are responsible for 99.7% of all cases of cervical cancer.
In addition to PapType, Genera has also commercialised and gained ARTG listing and CE mark for RTIplexTM, a single-well multiplex MDx that identifies 15 common upper respiratory tract pathogens, including Influenza A & B, as well as 10 other viral and three bacterial disease-causing microbial targets.
Genera’s development pipeline includes a new 8-plex sexually transmitted infections panel that is expected to be available in early 2018, with plans to broaden the AmpaSand test menu further to six highly competitive single-well multiplex MDx assays by 2019. PapType, RTIplexTM, and the tests in development, employ the AmpaSand biochemistry as well as Genera’s proprietary ARTG listed and CE-IVD marked QPlotsTM automated analytical and reporting software that is compatible with most Laboratory Information Management Systems (LIMS).
Mr Grigg said all the components of the Genera MDx system, including AmpaSand and QPlotsTM, have been optimised to run on Beckman Coulter’s innovative CytoFLEXTM flow cytometry system.
According tro Dr Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit, flow cytometry is a powerful tool for the detailed and fast analysis of complex populations.
“When this technique is utilized with Genera’s novel AmpaSand testing technology it also enables unparalleled multiplexing of molecular assays in a single-well. We are delighted that Genera has chosen CytoFLEXTM technology and are excited by the opportunity this partnership will provide AmpaSand assay customers when coupled with our leading instrumentation solutions.”
He says the fully enclosed high throughput system will seamlessly integrate the CytoFLEXTM technology with Beckman Coulter’s next generation automation system, the BiomekTM i-Series platform.
Demaris Mills, Vice President and General Manager of Beckman Coulter’s Automation Business Unit added that the Biomek i-Series platform is designed to enable continuous innovation to help customers meet their goals by delivering improved levels of simplicity, efficiency, adaptability, reliability and throughput.
“Our ability to deliver enhanced throughput is particularly relevant to pathology laboratories utilising AmpaSand based assays.”
A strategic roadmap has been developed for the staged release of products starting in Australia and then expanding in other geographies.