Thermo Fisher Scientific Showcases New Innovations for the Clinic During AACC 2019
Thermo Scientific Vanquish MD High Performance Liquid Chromatography (HPLC) system
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Thermo Fisher Scientific Inc., the world leader in serving science, showcased its latest instruments, assays and software for improving speed, accuracy and usability across clinical and research labs during the 71st American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Laboratory Exposition (AACC 2019).
“Clinical laboratories play pivotal roles in healthcare as expectations increase for diagnostic speed, accuracy and cost-savings,” said Patrick Durbin, senior vice president and president, specialty diagnostics for Thermo Fisher Scientific. “From more effective use of antibiotics to calls for faster lab-supported diagnoses, we’re continuously advancing our portfolio to meet the new and unmet needs of healthcare providers who are working to improve patient outcomes.”
Ease of Use, Speed to Result, Improved Diagnosis
Thermo Fisher offers a range of instruments, including Class I medical devices, that provide greater sensitivity and reliability for diagnostic testing across small and large molecules and within complex biological matrices.
• The Thermo Scientific Cascadion SM Clinical Analyzer*, currently approved for use in Europe, combines assays, software, accessories, consumables and support in a standalone system designed to meet the regulatory requirements for routine and specialized clinical LC-MS testing. Thermo Fisher is now preparing for clinical trials in 2019 as a next step toward submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.
• The ImmunoCAP Allergen Components test for Furry Animal allergens, recently cleared by U.S. FDA for in vitro diagnostic use, helps clinicians improve pet allergy diagnosis by analyzing sensitivity to specific proteins found in the skin, fur and saliva of dogs, cats and horses. Clinicians can better guide treatment plans by determining the primary allergen most likely causing symptoms. This helps to reduce the need to rehome pets due to owner allergies, informs more appropriate pet selection and assesses the risk of developing asthma.
• The Thermo Scientific Sensititre ARIS HiQ AST System, currently available in Europe with plans to launch in the U.S. subject to FDA clearance, is a benchtop automated reading and incubation system for antimicrobial susceptibility testing (AST). Thermo Fisher will showcase how the system provides laboratories with the accurate minimum inhibitory concentration (MIC) results clinicians require to confidently select effective antibiotics for patients. This capability also supports industry-wide antimicrobial stewardship efforts to reduce the use of antibiotics.
Instruments for Sensitive, Reliable Laboratory Developed Tests
Expanding on its industry-leading liquid chromatography and mass spectrometry offering for clinical diagnostic labs, the Thermo Scientific Medical Device (MD) portfolio of U.S. FDA Class I medical devices now include the Thermo Scientific Vanquish MD High Performance Liquid Chromatography (HPLC) system, the Thermo Scientific TSQ Altis MD Series mass spectrometer and the Thermo Scientific Quantis MD Series mass spectrometer.
These new systems join the company’s existing Prelude MD and Prelude LX-4 MD HPLC systems to form a more complete MD portfolio of analytical solutions for the diagnostic laboratory. These platforms enable clinical labs to achieve desired sensitivity and throughput goals while conforming to in vitro diagnostic (IVD) regulation. This helps ensure confidence in laboratory developed tests (LDTs) powered by a complete suite of LDT software with a laboratory information system.
Boosting Efficiency and Confidence in Results
New Thermo Scientific MAS controls with enhanced Thermo Scientific LabLink XL Quality Assurance Software and Auto-Connectivity Software offer daily quality control (QC) monitoring so clinical scientists and the medical staffs they support can more quickly and confidently access and apply results from laboratory diagnostic and prognostic tests. The MAS controls ensure adherence to clinical chemistry and immunoassay standards, enabling high daily throughput and efficiency without sacrificing quality. LabLink Software subsequently provides instant access to peer data and QC metrics without any additional work.
Additionally, the launch of an easy-to-handle, sustainable plate design for prepared culture media products in the U.S. and Canada supports the latest automated and manual methods for the analysis of microbiological samples for clinical, food safety testing and pharmaceutical laboratories.
Fully compatible with all available automated specimen processors, the SmartPlate design brings together Thermo Scientific Oxoid and Remel prepared culture media with an enhanced universal plate format for efficient and high-throughput isolation, identification, differentiation and screening of samples. The innovative SmartPlate technology offers a sustainable assay plate design that reduces the resin materials used to manufacture each plate, as well as minimizing laboratory waste due to its advanced durability.
“Clinical laboratories play pivotal roles in healthcare as expectations increase for diagnostic speed, accuracy and cost-savings,” said Patrick Durbin, senior vice president and president, specialty diagnostics for Thermo Fisher Scientific. “From more effective use of antibiotics to calls for faster lab-supported diagnoses, we’re continuously advancing our portfolio to meet the new and unmet needs of healthcare providers who are working to improve patient outcomes.”
Ease of Use, Speed to Result, Improved Diagnosis
Thermo Fisher offers a range of instruments, including Class I medical devices, that provide greater sensitivity and reliability for diagnostic testing across small and large molecules and within complex biological matrices.
• The Thermo Scientific Cascadion SM Clinical Analyzer*, currently approved for use in Europe, combines assays, software, accessories, consumables and support in a standalone system designed to meet the regulatory requirements for routine and specialized clinical LC-MS testing. Thermo Fisher is now preparing for clinical trials in 2019 as a next step toward submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.
• The ImmunoCAP Allergen Components test for Furry Animal allergens, recently cleared by U.S. FDA for in vitro diagnostic use, helps clinicians improve pet allergy diagnosis by analyzing sensitivity to specific proteins found in the skin, fur and saliva of dogs, cats and horses. Clinicians can better guide treatment plans by determining the primary allergen most likely causing symptoms. This helps to reduce the need to rehome pets due to owner allergies, informs more appropriate pet selection and assesses the risk of developing asthma.
• The Thermo Scientific Sensititre ARIS HiQ AST System, currently available in Europe with plans to launch in the U.S. subject to FDA clearance, is a benchtop automated reading and incubation system for antimicrobial susceptibility testing (AST). Thermo Fisher will showcase how the system provides laboratories with the accurate minimum inhibitory concentration (MIC) results clinicians require to confidently select effective antibiotics for patients. This capability also supports industry-wide antimicrobial stewardship efforts to reduce the use of antibiotics.
Instruments for Sensitive, Reliable Laboratory Developed Tests
Expanding on its industry-leading liquid chromatography and mass spectrometry offering for clinical diagnostic labs, the Thermo Scientific Medical Device (MD) portfolio of U.S. FDA Class I medical devices now include the Thermo Scientific Vanquish MD High Performance Liquid Chromatography (HPLC) system, the Thermo Scientific TSQ Altis MD Series mass spectrometer and the Thermo Scientific Quantis MD Series mass spectrometer.
These new systems join the company’s existing Prelude MD and Prelude LX-4 MD HPLC systems to form a more complete MD portfolio of analytical solutions for the diagnostic laboratory. These platforms enable clinical labs to achieve desired sensitivity and throughput goals while conforming to in vitro diagnostic (IVD) regulation. This helps ensure confidence in laboratory developed tests (LDTs) powered by a complete suite of LDT software with a laboratory information system.
Boosting Efficiency and Confidence in Results
New Thermo Scientific MAS controls with enhanced Thermo Scientific LabLink XL Quality Assurance Software and Auto-Connectivity Software offer daily quality control (QC) monitoring so clinical scientists and the medical staffs they support can more quickly and confidently access and apply results from laboratory diagnostic and prognostic tests. The MAS controls ensure adherence to clinical chemistry and immunoassay standards, enabling high daily throughput and efficiency without sacrificing quality. LabLink Software subsequently provides instant access to peer data and QC metrics without any additional work.
Additionally, the launch of an easy-to-handle, sustainable plate design for prepared culture media products in the U.S. and Canada supports the latest automated and manual methods for the analysis of microbiological samples for clinical, food safety testing and pharmaceutical laboratories.
Fully compatible with all available automated specimen processors, the SmartPlate design brings together Thermo Scientific Oxoid and Remel prepared culture media with an enhanced universal plate format for efficient and high-throughput isolation, identification, differentiation and screening of samples. The innovative SmartPlate technology offers a sustainable assay plate design that reduces the resin materials used to manufacture each plate, as well as minimizing laboratory waste due to its advanced durability.
