INDUSTRY MATTERS
Three Decades of Collaboration : Working with Public Health Labs for Diagnostic Excellence and Innovation
By Jennifer Schneiders , PhD , president , Hologic Diagnostic Solutions
“ Coming together is a beginning . Keeping together is progress . Working together is success .” – Henry Ford
Public health laboratories are truly the front line against infectious diseases , playing a vital role in diagnostic testing , reference testing and disease surveillance , while at the same time performing critical research to inform public health policy . For more than 30 years , Hologic has been honored to partner with public health laboratories and we are proud of the advancements we have achieved together .
Understanding the Importance of Flexibility
Prior to the pandemic , I had the fortune to attend the APHL Corporate Leadership Council . Although I have seen many levels of collaboration between laboratorians and industry over the years , I was amazed at the level of partnership that APHL has facilitated between public health laboratories and industry partners . Hologic is honored to have been one of the first and longest-standing industry partners with APHL .
This close partnership has helped provide our Research and Development teams with insight into the rapidly evolving needs of the modern molecular laboratory . While many public health laboratories often provide high-volume testing for sexually transmitted infections , there are numerous low-volume tests that require timely and accurate results . This need for flexibility resulted in the Panther ® system as the replacement for the large batch processing Tigris ® system . The Panther ® system was designed to be flexible — able to handle large-volume assays as easily as low-volume , with simplified workflow and minimal waste . Understanding constant budget and staff shortage challenges , improvements were designed to integrate into existing Panther ® systems , not requiring completely new instruments .
Laboratories Provide Crucial Insights for Assay Development
Being able to test for multiple organisms from the same sample is critical in public health . Given the uncertainty of patients returning to the clinic , the ability to provide a comprehensive diagnosis and appropriate treatment after the initial visit can help reduce costs and most importantly minimize further transmission .
Based on feedback from laboratories , Hologic developed the first FDA-cleared nucleic acid amplified test ( NAAT ) for Mycoplasma genitalium and is currently developing an M . genitalium macrolide resistance assay . As prevalence data continues to grow , the level of concern around this long-undiagnosed infection continues to rise . Hologic is partnering with some public health laboratories across the country to track M . genitalium and macrolide-resistant prevalence .
Open Access ™ Enables Tailored Testing and Collaboration
After SARS-CoV-2 was sequenced in early 2020 , Hologic used the Open Access ™ capability of our Panther Fusion ® module upgrade to develop and optimize our first SARS-CoV-2 test . Public health laboratories in Canada and Germany also used their own Panther Fusion ® systems to rapidly create laboratory-developed tests ( LDTs ) that could be fully automated and run at high volumes . Usage of this Open Access ™ capability by public health laboratories continues to rapidly grow . Today , public health laboratories around
the country are using Open Access ™ to develop LDTs for a variety of pathogens , including vector-born illnesses and emerging threats , such as Candida auris , which is often difficult to identify . Outbreaks of C . auris in healthcare settings are of particular concern , and many public health laboratories are initiating surveillance of this pathogen .
These experiences have brought laboratories from all over the country together to share information , and we have been proud to foster continued collaboration . We believe that publicprivate partnership is critical to solving public health crises and know that to be successful , we must all work together .
The Future Ahead Together
As we continue to move through this new world of public health testing , research and surveillance , we will continue to support you as you meet the testing demands of today and the demands of an unknown future . g
Hologic is a Diamond Level Sustaining Member of APHL .
10 LAB MATTERS Winter 2023
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