AACC 2023 Clinical Lab Expo: Highlights of Innovations

The 2023 AACC Annual Scientific Meeting & Clinical Lab Expo showcased breakthrough innovations shaping the future of clinical testing and patient care. The world's largest exhibition for in vitro diagnostics is hosted every year by the Association for Diagnostics & Laboratory Medicine (formerly AACC) (ADLM, Washington, DC, USA). AACC 2023 was held from July 23-27 at the Anaheim Convention Center in California, where laboratory medicine experts presented cutting-edge research and technology.

The AACC Clinical Lab Expo offered attendees the opportunity to browse more than 900 exhibitors across over 200 product categories in person for solutions to their lab-related needs. Attendees benefitted from a stunning lineup of expert speakers and scientific sessions, as well as view a vast array of emerging technologies and products at the premier global laboratory medicine exposition. They connected with global leaders in clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other fields of breaking science in laboratory medicine. With a diverse array of lectures, plenary sessions, scientific sessions, and roundtable sessions, the event provided more than 250 educational opportunities tailored to meet specific needs.

At the AACC 2023 scientific session, “Artificial Intelligence and Machine Learning in the Clinical Laboratories: Fundamental Concepts, Clinical Use Cases, and Future Considerations,” attendees learned about the role that AI and ML can play in the clinical laboratory. In an interesting session, “Infectious Disease Serology: Are You Still Ordering That Test,” different speakers shared case studies, insightful experiences, and guidance on how to effectively manage infectious disease serology testing. Another AACC session titled "Data Analytics Competition: Forecasting Future Preanalytical Errors" focused on the issue of excess of hemolyzed samples faced by several institutions who are keen on understanding how to address this problem while preserving scarce resources. In the "Emerging Trends in Laboratory Medicine: Excellence from the Global Community" session, global lab experts shared their knowledge and insights on several trending topics: pandemic readiness, environmental sustainability, and machine learning.

New research presented at AACC 2023 showed that an AI model can predict the likelihood of individuals developing multiple sclerosis (MS) years before its diagnosis. In other new research presented at AACC 2023, the study results showed that self-collected tests are as effective as provider-collected tests in detecting prevalent sexually transmitted infections (STIs). Another breaking research presented at AACC 2023 threw light on the co-infection rates of SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) in the United States.

Pattern Bioscience, Inc. (Austin, TX, USA; www.pattern.bio) won the 2023 Disruptive Technology Award for its ground-breaking single-cell microbiology technology. The Disruptive Technology Award competition from ADLM honors innovative testing solutions and disruptive technologies that enhance patient care via diagnostic performance or improved access to high-quality testing. Unlike PCR or sequence-based methods that evaluate genetic targets linked to resistance, Pattern’s single-cell microbiology technology directly measures the response of bacterial cells to antibiotics, thereby determining exactly which agents can be employed for therapy. This process is similar to standard-of-care culture methods, but significantly faster.

Vital Biosciences (Toronto, ON, Canada; www.vitalbio.com) introduced its game-changing product, the VitalOne which aims to democratize blood diagnostics by making over 50 lab-grade tests — covering 95% of routine lab orders — available at primary care locations, all packaged within a device no bigger than a desktop computer. With the VitalOne, physicians can conduct tests, diagnose, and treat patients all in one appointment, with results obtained in 20 minutes. The underlying technology has been rigorously tested and validated against thousands of samples in comparison to gold-standard instruments, through collaborations with Vital's lab partners. The VitalOne is currently in its late-stage product development and is yet to be made commercially available. The VitalOne was recognized as the Audience Choice winner at this year's AACC Disruptive Technology Award.

Bio-Rad Laboratories (Hercules, CA, USA; www.bio-rad.com) showcased its comprehensive range of quality control-related offerings, including the new Cardiac Advance product, Exact Diagnostics branded infectious disease molecular quality controls & panels, the family of InteliQ Load-and-Go controls, and Unity Next Peer QC data management solutions. Bio-Rad also demonstrated the D-100 hemoglobin testing system, a fully automated, best in class HbA1c analyzer for high-volume labs, alongside the BioPlex 2200 System, a fully automated, random-access, track line compatible, multiplex platform.

Thermo Fisher Scientific Inc. (Waltham, MA; USA; www.thermofisher.com) presented its dynamic range of products that can help laboratories maximize productivity and innovation. The company also offered live demonstrations of its Indiko and Indiko Plus clinical and specialty chemistry analyzers, and the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System and Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System. In addition, Thermo Fisher hosted industry leading workshops where experts discussed the company’s latest innovations for preeclampsia testing with its new biomarkers PlGF and sFlt-1 that can help manage preeclampsia and neuroendocrine tumors.

Tianlong Science and Technology (Shaanxi, China; www.tlgenetech.cn), an innovative high-tech company specializing in molecular diagnostic products, showcased its extensive range of products as well as solutions for the molecular diagnostic industry. Tianlong demonstrated its game changing GeneRotex 96 nucleic acid extractor which is based on the automatic extraction principle of magnetic bead adsorption separation. The GeneRotex 96 Nucleic Acid Extractor is designed with Tianlong’s innovative Rotational Mixing Technology (RMT), which reduces aerosol generation during purification, minimizes the risk of false positives due to cross-contamination, and ensures the accuracy of experimental results.

Beckman Coulter, Inc. (Brea, CA, USA; www.beckmancoulter.com) launched its hematology analyzer and slidemaker stainer connected to Scopio Labs’ (Tel Aviv, Israel; www.scopiolabs.com) digital morphology platform for end-to-end digitization with AI-assisted peripheral blood smear analysis. The solution features the Beckman Coulter DxH 900 Workcell and DxH Slidemaker Stainer II connected with the Scopio X100HT digital morphology platform capable of continuous loading, scanning and analysis. The company also exhibited its new high-throughput DxI 9000 Access immunoassay analyzer that is designed for superior laboratory performance and demands no daily maintenance. In addition, Beckman Coulter hosted a workshop to discuss new opportunities for laboratories to reduce QC and operational costs, as well as eliminate unnecessary repeats, recalibrations, and troubleshooting episodes, even in the face of CLIA's tighter standards.

Siemens Healthineers (Erlangen, Germany; www.healthcare.siemens.com) highlighted its newest innovations and trends in clinical diagnostics and point-of-care testing, including its Atellica Integrated Automation which is powered for workflow and workforce efficiency to deliver control and simplicity so labs can drive better outcomes. The company’s experts also demonstrated how the IMMULITE 2000 XPi immunoassay system can address common challenges faced by specialty laboratories. Visitors to the Siemens booth experienced the first view of the company’s newly-launched Atellica CI Analyzer, a compact testing system designed to tackle lab challenges.

Roche Diagnostics (Basel, Switzerland; www.roche.com) showcased its latest advancements in lab automation, core lab systems, and molecular and point-of-care solutions, as well as in breakthrough high-medical-value diagnostic and digital solutions that are transforming patient care. Roche featured its newest innovations including the cobas 5800, a compact, fully-automated molecular PCR-testing solution with a comprehensive menu of assays, and cobas pure integrated solutions, which combine clinical chemistry, immunoassay and Ion-Selective Electrode (ISE) diagnostic testing on a single platform for low- to mid-volume testing needs. The new cobas connection modules (CCM vertical), a flexible modular system that uses lab space effectively and seamlessly integrates into the existing cobas connection modules, was also highlighted, along with Roche’s vision for the transformation of mass spectrometry testing.

Greiner Bio-One (Monroe, NC, USA; www.gbo.com) presented its innovative collection systems and safety products for venous and capillary blood and urine samples. The company also highlighted its research workflow solutions, including specialized products for the cultivation of cell cultures, microplates for high-throughput screening, biobanking solutions, and more. Greiner showcased its new VACUETTE CAT Serum Fast Separator enables that complete clotting of the whole blood sample in just five minutes, offering a decisive time advantage compared to conventional serum tubes. Greiner also highlighted its Sapphire product family of pipette tips, filter tips and low retention tips alongside its magnetic 3D cell culture solutions based on magnetization of cells with NanoShuttle-PL.

Werfen (Barcelona, Spain; www.werfen.com) offered in-booth demonstrations of its point-of-care and laboratory instruments, reagents, and data management solutions. Werfen provided instrument demonstrations of its wide range of systems, including the ACL TOP Family 50 Series, HemoCell Specialized Lab Automation, HemosIL assays, HemoHub Intelligent Data Manager; GEM Premier 5000, GEM Premier ChemSTAT, GEM Hemochron 100, ROTEM sigma, VerifyNow, GMweb Plus 500, Aptiva, BIO-FLASH, QUANTA-Lyser, QUANTA-Link; Echo Lumena, and NEO Iris. The company also offered a virtual reality experience featuring customized layouts for HemoCell Lab Automation.

CerTest Biotec (Zaragoza, Spain; www.certest.es), a company specialized in the development, manufacturing, and commercialization of solutions for the diagnosis of infectious diseases, showcased its product range of rapid tests, RT-PCR tests (based on molecular biology), chemiluminescence (CLIA), and turbidimetry, in addition to raw materials for diagnostic product manufacturers. Certest demonstrated the VIASURE Complete System which is an integrated system offering a comprehensive solution for the diagnosis of infectious diseases, providing fast and reliable results that improve workflow in the diagnostic laboratory. Certest also presented up to 14 publications in the form of posters, reflecting the latest studies conducted by the company, mainly in the field of molecular biology.

CellaVision (Lund, Sweden; www.cellavision.com) showcased some of its latest products, including its new DIFF-Line complete workflow solution for low-volume hematology laboratories. DIFF-Line by CellaVision is a complete workflow for smearing, staining, and analyzing peripheral blood smears in hematology labs that handle a smaller amount of daily blood samples. Advancing into the area of digital bone marrow analysis, CellaVision also shared a preview of its upcoming bone marrow application.

HUMAN Diagnostics (Wiesbaden, Germany; www.human.de), a leading global provider of in-vitro diagnostic solutions, showcased its cutting-edge products and also engaged with industry professionals, researchers, and healthcare experts. Among the company’s products featured at the exhibition was the HumaCount 5D CRP, an innovative hematology analyzer that provides rapid and precise measurement of C-reactive protein (CRP), a crucial biomarker for inflammation assessment. The company also highlighted the HumaFIA system, a high-performance fluorescence immunoassay analyzer designed for rapid and sensitive measurement of various analytes.

Puritan Medical Products (Guilford, ME, USA; www.puritanmedproducts.com), the world's most trusted manufacturer of swabs, exhibited its patented HydraFlock and PurFlock Ultra flocked swabs and other globally-renowned products. By combining user feedback and a proprietary research manufacturing process, the company has developed a patented, intricate fiber technology that provides the highest collection and elution capacities available on the market. The company also demonstrated its expertise in topics such as automation, pandemic response, and virus protection, participating in panel discussions, joining in-depth symposiums, and introducing its various experts to their global counterparts.

Jiangsu Bioperfectus Technologies Co., Ltd. (Shanghai, China; www.bioperfectus.com) showcased its dependable solutions for every laboratory's PCR needs while also highlighting its automatic nucleic acid extraction systems alongside its range of RUO products and raw materials for life science solutions. Bioperfectus Total PCR Solution offers holistic products of extraction systems, extraction reagents, real-time PCR systems, and RT-PCR reagents. The company’s new SSNP-2000B nucleic acid extraction system exhibited at the show integrates advanced technologies such as machine, electricity and computer software to enable the automatic nucleic acid extraction of a maximum of 32 samples at one time. Bioperfectus also showcased the STC-96A Plus Real-Time PCR System which is a more flexible, efficient and reliable breakthrough in real-time PCR analysis of gene expression and genetic variation.

LGC Clinical Diagnostics (Middlesex, UK; www.lgcgroup.com) showcased is full portfolio of quality measurement tools with complete access to its sub-brands including Maine Standards, SeraCare, Technopath Clinical Diagnostics, and The Native Antigen Company. LGC’s combined capabilities makes it better positioned to support the needs of the clinical diagnostics industry, from early feasibility and research to commercial & laboratory development test (LDT) assay development, installation, validation and ongoing performance monitoring support.  LGC presented VALIDATE linearity & calibration verification materials, ACCURUN reference materials & QC products, the Multichem range of independent quality controls, and the VirtuE range of antigens & antibodies.

Globe Scientific, Inc. (Mahwah, NJ, USA; www.globescientific.com) exhibited its newest 2023 laboratory plasticware, glassware and equipment, including Globe | Euormex microscopes and its expanded Globe Glass laboratory glassware and PCR product lines. Visitors to the company’s booth were provided an overview of the complete Globe product portfolio with real, live product experts available to walk them through their preferred area of interest. Visitors also discovered Globe’s latest range of high-precision balances, engineered to deliver accurate measurements and enhance workflow efficiency. Among the impressive lineup of lab essentials and equipment showcased by Globe was the Globe | Euromex Microscopes.

Getein Biotech, Inc. (Nanjing, China; www.getein.com) showcased its latest innovations, including its benchtop immunofluorescence and hematology analyzers as well as its handheld POCT analyzers. Getein demonstrated the Metis 600 integrated system that provides a suitable solution for immunofluorescence and hematology testing to low volume laboratories. In addition, the company demonstrated the Getein 1160 immunofluorescence quantitative analyzer - a multi-channel POCT analyzer with four incubation channels and one emergency test channel. Alongside the Getein 1160, the company demonstrated the Getein 1100 immunofluorescence quantitative analyzer that is used to measure the concentration of biomarkers in human whole blood, serum, plasma, urine, nasal swab, or saliva samples. The results can be used as an aid in clinical diagnostics of laboratory and point-of-care testing.

Wondfo (Guangzhou, China; www.wondfo.com) provided a glimpse of several newly-launched products alongside its flagship products such as the Finecare FIA Meters (FS-114/FS-205), Accre CLIA Analyzer (A90) and Blood Gas Analyzer (BGA-102). At the Wondfo booth, Carolina Liquid Chemistries, Corp. (CLC, Greensboro, NC, USA; www.carolinachemistries.com) showcased the RYAN, the "next generation" of fentanyl testing. RYAN is a portable fluorescence instrument that can be used in a laboratory or point-of-care setting with the Fentanyl Urine Detection Kit which is the first ever FDA cleared and CLIA categorized point-of-care fentanyl test. This fluorescence immunoassay is intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

DiaSys Diagnostic Systems (Holzheim, Germany; www.diasys-diagnostics.com) exhibited its comprehensive portfolio of clinical chemistry analyzers, reagents, calibrators and controls, and also presented a scientific poster on procalcitonin. Among the company’s products highlighted at the show was the DiaSys CRP FS liquid-stable immunoturbidimetric test with dedicated ready-to-use calibrators and controls that allow true differentiation of borderline cases. DiaSys has recently extended its cardiovascular risk assessment portfolio by two innovative new reagents, HDL-c direct FS and LDL-c direct FS. Both are homogenous assays for direct determination. DiaSys has also expanded the application range for its Total bile acids 21 FS reagent and now offers the assay for use in serum and stool samples.

Randox Laboratories (Crumlin, UK; www.randox.com) exhibited its cutting-edge diagnostic products and solutions, while also highlighting its groundbreaking technologies. Randox’s new Acusera Quality Controls for 2022/2023 highlighted at the show included Active B12, Anti Mullerian Hormone (AMH), Brain Natriuretic Peptide (BNP) Control, Bone Markers (Serum) Control, Pre-eclampsia Control, Serum Indices Control, Ultra-Low PSA Control, Xanthochromia Control. Randox also showcased its recently launched Xylazine ELISA which is the first immunoassay test in the world for this drug of abuse and is available on the Evidence MultiSTAT analyzer. In addition, Randox unveiled Randox Health Labs located in Santa Monica, California. In recent years, Randox has been expanding its Randox Health testing – bringing preventative healthcare directly to the public. Randox’s extensive test menu offers over 150 analytes, allowing individuals to access to some of the most specialized tests available in the market today.

Meridian Bioscience Inc. (Cincinnati, OH, USA; www.meridianbioscience.com) unveiled two new animal-free immunoassay interference blockers, K-Block, and Mouse-Free IgG, launched by its Life Science division. These innovative blockers are completely animal-free and provide comparable or superior performance than traditional animal-derived blockers. Meridian's new K-Block and Mouse-Free IgG overcome the obstacles associated with conventional animal-based blockers. These advanced blockers enhance assay specificity, reduce lot-to-lot variability, comply with sustainability considerations, and minimize contamination risks from animal-derived components. Preliminary testing in ELISA-based assays has revealed a strong performance of K-Block and Mouse-FREE IgG compared to other commercial animal-derived blockers.

Fapon Biotech (Guangdong, China; www.faponbiotech.com) introduced its latest chemiluminescence immunoassay (CLIA) system, the Shine i8000/9000. This ultra-high throughput, fully automated analyzer delivers initial results within 10 minutes at a rate of 900 tests per hour. The system's high throughput per footprint, delivering 377 tests/hour/m2, makes it an ideal choice for labs seeking to boost their testing capacity and efficiency. The launch of the Shine i8000/9000 further expands the company's extensive portfolio of high, medium, and low-throughput chemiluminescence analyzers. Fapon also delivered an interactive lecture titled "Bioanalytical Performance of Novel Protein-free Blockers & Heterophilic Antibody Interference Blockers for the IVD Industry & Clinical Diagnostics," offering insights into the latest advancements in IVD blockers.

General Biologicals Corporation (GBC, Hsinchu, Taiwan; www.gbc.com.tw) introduced two CellBio circulating tumor cell (CTC) cancer detection systems that are recognized globally as cutting-edge products offering rapid, accessible, and affordable diagnostic solutions for early detection, treatment validation, and therapy monitoring. The CellBio platform employs GBC's proprietary iFiltration technology to provide positive control and guarantee filtration accuracy. It offers several advantages including high specificity, sensitivity, and cancer capture rate from 7.5-mL blood samples, delivering results within 90 minutes. GBC also launched its automated all-in-one molecular system, GB RealQuant AIO. This integrated instrument combines extraction, amplification, and detection, delivering fast and reliable results within two hours with high flexibility.

Hilab (Manaus, Brazil; www.hilab.com.br), a frontrunner in innovative healthcare solutions, launched a unique point-of-care Hemogram device—the world's only instrument capable of providing a comprehensive blood count using AI and other cutting-edge technologies within just 30 minutes. Hilab also introduced two more devices — the Hilab Volt and the Hilab Wave. The Hilab Volt, which works on the principles of electrochemistry, reads an electrode that selectively interacts with the sample, generating an insightful analytical electrical signal. It can help evaluate parameters such as calcium, sodium, potassium, iron, and glucose, among others. The Hilab Wave, functioning via spectrophotometry—an optical analysis methodology used for quantitative measurement of light absorption by solutions—facilitates numerous tests, including those for phosphorus, magnesium, cholesterol, Vitamin D, and even for detecting Malaria.

OnsiteGene Inc. (San Diego, CA, USA; www.onsitegene.com) presented the world's first large sample volume, open-assay, super-fast, ultra-sensitive, and sample-to-answer PCR instrument. The groundbreaking PeakV from OnsiteGene represents a paradigm shift in PCR testing. By utilizing rapid thermal cycling and real-time fluorescent imaging to perform 40 cycles within a span of just five minutes, it delivers an unmatched performance. The device can carry out low copy multiplex qPCR in merely seven minutes and RT-qPCR in nine minutes. Equipped with a substantial sample volume capacity of up to 5mL, PeakV also features automated nested PCR and magnetic beads-based nucleic acid extraction, thereby enhancing its sensitivity and specificity, outperforming conventional qPCR techniques.

SARSTEDT (Nümbrecht, Germany; www.sarstedt.com), a leader in pre-analytic innovation, demonstrated its solutions for improving specimen quality, reducing turnaround time, and automating labs of all sizes with customizable modular systems. On display was the SARSTEDT Tempus600®, a dedicated transportation system for sending specimen tubes quickly and reliably to the laboratory without batching or packing into carriers. SARSTEDT demonstrated how the Tempus600® and IVD systems such as the Roche cobas® connection modules work together to shorten the time between tests being ordered and results being ready. Visitors watched how blood collection tubes left the SARSTEDT booth and arrived at the Roche booth in seconds.

Prevencio, Inc. (Kirkland, WA, USA; www.prevenciomed.com) showcased its leading-edge, AI-powered HART platform and blood tests. The HART platform is disease agnostic, thereby allowing the development of diagnostics that extend beyond cardiac diseases. Presently, Prevencio's two primary tests, HART CVE and HART CADhs, are accessible to medical professionals for patient use. HART CVE calculates a patient's one-year risk for a heart attack, stroke, or cardiovascular death, whereas HART CADhs evaluates if a patient has a blockage in the heart arteries, indicating an imminent risk of a heart attack.

PBD Biotech (Birmingham, UK; www.pbdbio.com) showcased Actiphage, a phage-based test that detects Mtb in the blood – which is considered an early indicator of ‘active’ TB disease. The test shows potential for screening latent TB and drug management. Actiphage combines phage-based DNA extraction with polymerase chain reaction to identify low levels of viable Mtb in blood. Actiphage was also highlighted in the AACC webinar titled "Phage-Based Laboratory Diagnostics Role in the Detection of Tuberculosis," sponsored by PBD Biotech. At the webinar, experts discussed the epidemiology of tuberculosis and the limitations of current tests that assess host response. Attendees gained insights into how phage-based diagnostic technology can be employed to detect incipient and active TB.

The AACC Annual Meeting & Clinical Lab Expo 2024 will take place 28 July - 1 August 2024 in Chicago, IL, USA.

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