Lab Matters Spring 2025 | Page 11

INDUSTRY MATTERS

By Jonathon Zowalki , product manager , Hologic and Ashley Nenninger , PhD , senior manager , Scientific Affairs , Hologic

The Serology Team at Wisconsin State Hygienic Laboratory . Photo : Hologic .

The Molecular Diagnostics Team at the State Hygienic Laboratory at the University of Iowa . Photo : Hologic .

For decades , public health laboratories have been on the frontlines of testing for locally and globally emerging pathogens . While there are shared diagnostic goals across the public health laboratory network , individual laboratories have their own distinct testing priorities .

Molecular diagnostic testing systems , which offer flexibility and scalability , are key to supporting the unique testing needs and dynamics of each public health laboratory . Open channel functionality on these systems enables laboratories to customize their testing menus by integrating laboratory-developed tests ( LDTs ) alongside commercially available in vitro diagnostic ( IVD ) assays . LDTs are often used to respond to local infectious diseases and changing clinical needs facing specific communities when a commercial testing solution does not exist .

LDTs have historically been implemented on manual platforms , which require significant operator hands-on-time . By automating manual testing workflows , laboratories can process larger volumes of tests with fewer resources , potentially speeding up diagnoses and enabling timely public health interventions .

Dr . Allen Bateman oversees the Communicable Diseases Division at the Wisconsin State Hygienic Laboratory . In the face of increasing testing demand , his laboratory turned to Panther Fusion ® Open Access ® , a sample-to-result molecular testing system that enables automation of LDT and IVD testing workflows simultaneously .

“ The Panther Fusion system ’ s automation for SARS-CoV-2 testing really streamlined our testing during the depths of the COVID-19 pandemic , so we sought additional uses for this high-throughput automated workflow ,” said Bateman . “ As an AR Lab Network Regional Laboratory , the volume of specimens for Candida auris PCR was very high ( often over 100 per day ) and growing , and we were using manual extraction and PCR approaches . We validated an LDT for C . auris PCR on the Panther Fusion Open Access and went live in January 2024 . The relief among our testing staff was immediate , and they continue to really appreciate the automated nature of the testing . We will soon go live with an LDT for Carbapenemresistant Acinetobacter baumannii ( CRAB ) colonization testing , which we expect to have a similar streamlining effect and relief among microbiologists .”

Public health laboratories continue to see similar benefits when automating workflows for tests that are associated with fluctuating testing volumes , such as seasonal pathogens . Megan Ahmann , a fellow at the State Hygienic Laboratory at the University of Iowa , utilizes automation to support their environmental surveillance efforts in ticks in addition to their other clinical LDTs .

“ We were able to create bi-directional interfacing between the Panther Fusion system and our LIMS ,” said Ahmann . “ Through this process , our LIMS directs worklists of specimen IDs and their assigned assays to the Panther , and in turn , the Panther automatically relays and populates the results after processing back to our LIMS in real-time . This feature virtually removes the need for manual test assignment , eliminates technician transcription error when resulting , and significantly reduces overall turnaround time , especially with high-volume testing . For laboratory-developed PCR assays , this seamless sample-to-result workflow is the new gold standard .”

While the Open Access functionality on Panther Fusion enables laboratories to implement their own customized testing solutions , it has also allowed Hologic to rapidly develop Emergency Use Authorization tests in the past to respond to emerging health threats ( e . g ., SARS-CoV-2 ), and could be similarly utilized in the future for new emerging pathogens .

Whether it be for outbreak response or routine surveillance efforts , Panther Fusion ’ s Open Access functionality empowers public health laboratories of all shapes and sizes to automate their testing on a sample-to-result , flexible throughput molecular testing system . g