BD has been a global leader in infectious disease diagnostics and management for a long time. Our microbiology and molecular diagnostic instruments are used to detect everything from respiratory viruses to sexually transmitted infections and to identify the drugs to which antibiotic-resistant pathogens might be susceptible. Over the years, other BD divisions have also played a critical role in infectious disease management, from syringes delivering the polio vaccine to flow cytometry instruments helping monitor immune function of HIV patients.
COVID-19 has underscored that our expertise in infectious disease diagnostics and our relationships across the industry have never been more critical. Over the last few months, we have developed COVID-19 molecular diagnostic tests on our own and in collaboration with CerTest and BioGx that leverage the BD MAX™ Molecular System to help clinicians detect SARS-CoV-2 and diagnose COVID-19 infection. We received FDA Emergency Use Authorization for a 15-minute antigen-based diagnostic test for rapid, point-of-care SARS-CoV-2 detection using the BD Veritor™ Plus System. In addition, with our partner Copan, we have validated and increased our capacity for producing multiple types of swabs and are shipping millions of these critical specimen collection and transport devices each week. Across our COVID-19 diagnostics portfolio, we are investing in expanding our production capacity through new production lines and greater use of automation.
Over the past few years, we have aligned our portfolio to the trends we see happening across the diagnostic continuum, including greater use of laboratory automation, point-of-care technologies and connectivity tools. COVID-19 has shined a spotlight on the need for greater diagnostic capacity and flexibility and has illustrated the need for a variety of diagnostic solutions built for different care settings. This has been our focus, streamlining the diagnostic process for large-scale centralized laboratories, acute care settings, such as hospital microbiology laboratories, and emerging outpatient health care destinations (physician offices, urgent care centers, retail pharmacies, etc.).
At BD, we are proud to be building upon our legacy of leadership in diagnostics to deliver solutions to serve our customers’ needs this year and well beyond the present crisis.
Leveraging laboratory automation and connectivity to streamline laboratory operations
BD has long recognized the opportunity that laboratory automation and connectivity bring to clinical microbiology. We understand that hospital microbiology laboratories face numerous pressures and disruptions, from an aging workforce and hospital system consolidation, to increasing test volumes and reduced reimbursement rates in many geographies. New tools are needed to enable laboratories to provide clinicians (and ultimately patients) with quick answers.
To meet these needs, BD has continued to add new modules to our BD Kiestra™ laboratory automation portfolio, most recently including BD Kiestra™ ReadA, BD Kiestra™ IdentifA and BD Kiestra™ InoqulA solutions. These modules automate the plate management and sample preparation and processing steps required to identify microorganisms, helping to reduce user error in these traditionally manual tasks.
In 2018, the company launched the BD Synapsys™ informatics solution. Like blood culture and automation solutions, this informatics tool helps clinical laboratories and testing sites using BD Veritor™ Plus Systems address the challenges they face with recording results in patient records, and reporting results to local, state and federal health departments and agencies. The easy-to-use, browser-based application helps in streamlining workflows and automating manual processes needed to report patient results to clinicians, and provides insights to help impact testing site performance. These tools help laboratories improve productivity, simplify compliance and prevent errors due to manual transcription. We’re also extending connectivity options to collect COVID-19 test data performed on BD Veritor™ and BD MAX™ in all settings, and further improve COVID-19 analytics capabilities in labs and across healthcare organizations around the world.
Providing molecular diagnostic solutions for every care setting
Over the past few years, BD and our partners have built a menu of assays for the BD MAX™ Molecular System, which can perform both IVD and open system assays. It is widely used in acute environments like hospital microbiology labs, which leverage its ability to run multiple specimen types and assays simultaneously with limited hands-on time. While our SARS-CoV-2 assays are getting all of the attention, we offer a wide variety of assays for women’s health, sexually transmitted infections, enteric conditions and healthcare associated infections for this system.
For core laboratories and other large centralized laboratories, the company offers the BD COR™ molecular system, currently CE-IVDD certified, in Europe. Purpose-built for large-scale labs, the BD COR™ system integrates and automates the complete molecular laboratory workflow from pre-analytical processing to diagnostic test result. Over the coming years, the company plans to continue seeking regulatory authorizations to sell the BD COR™ system around the world while expanding the content menu to include assays for a variety of diseases.
The global pandemic has also shown the importance of widely deploying rapid diagnostics. In addition to our antigen-based point-of-care tests for the BD Veritor™ Plus System, BD is also actively developing a molecular diagnostic platform for point-of-care testing, which will ultimately enable the company to bring a menu of assays to physician offices, urgent care, and retail settings. The technology was initially invented by NAT Diagnostics, Inc., an early stage, privately held company, which BD acquired earlier this year.
Looking forward: building new solutions for near-patient testing
COVID-19 has demonstrated the need for solutions to inform clinicians to quickly diagnose infectious diseases within the span of an office visit, or at another testing location. In addition to our efforts to develop our molecular point-of-care test offering, our specimen management team is working to develop new devices based on our well-established BD Vacutainer® technology to bring lab accuracy to point-of-care blood collection. BD is working closely with our partner Babson Diagnostics to validate the first of these new products, a capillary blood collection device, so that we can begin the process of completing regulatory filings needed to bring it to the market.
With influenza season rapidly approaching and COVID-19 still spreading in many communities across the U.S. and around the world, there remains strong interest in the BD Veritor™ Plus System for its simplicity, ease of use, and broad applicability across CLIA-waived environments. With the growth in our installed base of these instruments and manufacturing capabilities to serve patients suspected of having COVID-19, we plan to continue our innovation of assays for respiratory viruses—including a new SARS-CoV-2 and influenza assay—on this quick and affordable instrument.