Thermo Shows New Clinical Innovations

(Waltham, MA; USA) showcased its latest instruments, assays and software at the 71st American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Laboratory Exposition (AACC 2019) held in Anaheim, California, USA, on August 4-8.

Thermo Fisher offers a range of instruments, including Class I medical devices, which provide greater sensitivity and reliability for diagnostic testing across small and large molecules and within complex biological matrices. At AACC 2019, Thermo Fisher highlighted its Cascadion SM Clinical Analyzer, which 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. The Cascadion SM Clinical Analyzer is currently approved for use in Europe and the company is now preparing for clinical trials for submission to the US FDA for obtaining 510(k) clearance. Thermo Fisher showcased its ImmunoCAP Allergen Components test for Furry Animal allergens that 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 re-home pets due to owner allergies, informs more appropriate pet selection and assesses the risk of developing asthma.

The company also highlighted its Sensititre ARIS HiQ AST System, which is a benchtop automated reading and incubation system for antimicrobial susceptibility testing (AST). Thermo Fisher showcased how the system provides laboratories with the accurate minimum inhibitory concentration (MIC) results required by clinicians to confidently select effective antibiotics for patients. This capability also supports industry-wide antimicrobial stewardship efforts to reduce the use of antibiotics.

At AACC 2019, Thermo Fisher showcased its liquid chromatography and mass spectrometry offering for clinical diagnostic labs, including the Vanquish MD High Performance Liquid Chromatography (HPLC) system, TSQ Altis MD Series mass spectrometer and Quantis MD Series mass spectrometer. The company has added these new systems to its 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.

Thermo Fisher also showcased its MAS controls with enhanced LabLink XL Quality Assurance Software and Auto-Connectivity Software that 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.

The company also highlighted its new easy-to-handle, sustainable plate design for prepared culture media products that 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 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."