Rapid Point of Care Chemistry Testing

Chemistry and Hematology testing have become highly automated with large instrument lines capable of processing high volumes of blood specimens and supporting various assays, such as those for electrolytes, lipids, and glucose to name a few. These results do not provide a definitive diagnosis, but support physicians in assessing patient health. The centralized lab model ensures standardization of testing and allows high throughput, but often delays results and means patient follow up calls or visits are required to discuss results. Several companies presented new data and studies highlighting novel rapid point of care chemistry analyzers that would allow testing near the patient with results available in less than 30 minutes.

At ADLM, several companies presented novel rapid point-of-care (POC) chemistry analyzers designed to deliver results in under 30 minutes. A few newer companies that presented data on their analyzers were Fluxergy, Truvian, VitalOne and Chronus Health.

• Fluxergy is developing a small benchtop instrument that uses a multi-modular test card that can perform various assays including chemistry, cytometry, immunoassay, and molecular assays. Panels can include 12+ markers per card and results as quick as 5 minutes depending on the assay.
• Truvian showcased a benchtop analyzer that generates up to 34 results, which include chemistry and lipid panels, TSH, HbA1c, and CBC from a single 300µl whole blood specimen, with results in 30 minutes.
• VitalOne from Vital Bio is developing a benchtop chemistry assay that offers various panels including CBCs, lipid, liver function and metabolic panels. Testing uses 300-600µls of blood and results are obtained in 15-20 minutes.
• Chronus Health is developing what they refer to as “the first real-time electrical blood test system”. This unique system uses electrical sensors, requires no sample prep, and can perform a variety of assays including CBC, chemistry and immunoassays in 15 minutes.

Established companies, such as Abbott, also continue to innovate in the POC chemistry space.  The company presented several new studies evaluating the Abbott i-STAT device.  The i-STAT is a handheld instrument that uses a few drops of blood which are loaded into their various assay cartridges and delivers results in minutes.

 

Oncology Screening  

Another standout to the show was the improvements in oncology diagnostics and the rapid screening of patients.  Two posters caught our eye, one by DXCOVER and another by Mercy BioAnalytics.    

• DXCOVER uses an infrared spectrum screening approach that places 9uls of serum onto their sample slide, which is then placed into their Discover PANAROMIC™ platform.  The resulting spectrum, comprised of a distribution of protein, lipid, phosphate and carbohydrates, is compared using their diagnostic algorithm to differentiate between healthy and disease states.  The poster reported on various studies that evaluate the system for detecting brain, colorectal, and general cancer vs non cancer (8 different types).
• Mercy BioAnalytics uses Extracellular Vesicles (EV), a class of biomarkers for detection of cancer.  These vesicles are released at high levels and can be found in blood, suggesting they are a highly sensitive and specific target to identify cancer early in patients.  Their Mercy Halo™ platform uses qPCR technology after enrichment of EVs using antibody capture.  In studies presented at ADLM, the platform demonstrated 89% sensitivity in patients with stage I/II ovarian cancer and 97.7% specificity.  Mercy BioAnaltyics was also the winner of ADLMs 2024 disruptive technology award.  

 

Mass Spectrometry 

There were a considerable number of companies focused on mass spectrometry.  As we see innovation occurring in this area due to its high sensitivity, specificity and accuracy, the race is on to develop a high throughput, less complex and user-friendly analyzer, as well as one that provides integration into the standard laboratory and standardization across laboratories.

Many are honing in on the complete integration of clinical chemistry and immunochemistry, robotics, and full automation. In drug discovery, mas spectrometry’s ability to utilize unlabeled biomolecules allows for the expansion in the number targets high throughput can be developed for.

 

Overall Impression

Altogether, the conference was an exciting insight into the innovation occurring in the field.  We’reexcited to see the progress of these assays and as always happy to collaborate and support novel technology navigate the FDA approval process.