A Medical Device Daily
At the annual meeting of the American Association for Clinical Chemistry (AACC; Washington) in Chicago, Axela (Toronto) launched panelPlus Sensors for real-time multiplex protein biomarker detection and an introductory assay menu for oncology, cardiology and infectious disease research. The assay format provides the industry's first real-time, user configurable multiplex assays.
"When you combine real time information with multiplexing, it enables you to do things you haven't been able to do to date," Rocky Ganske, president/CEO of Axela, said during a presentation at AACC. "It's a combination of real-time detection of proteins and multiplexing in one platform."
Biomarker discoveries can be analyzed with existing markers to facilitate both validation and routine analysis of new panels.
"Simplifying multiplex assay development removes a major bottleneck in biomarker research," Ganske said. "The approach has already led to novel clinical applications that will be commercialized with partners or directly in Axela's future diagnostic offerings"
Designed with optics technology, the dotLab System uses flow-based real-time detection to deliver significantly more information from every analysis.
The integration of multiplex capabilities with dot technology reduces sample consumption, handling, time to result and costs while generating superior data quality, he said.
The panelPlus Multiplex Sensors will initially be offered for research use only on the dotLab biomarker analysis platform.
"We are working with partners on a point-of-care system under development," Ganske said. "We're clearly trying to address the biomarker challenges. We're building a pipeline to diagnostics."
Axela's first clinical indications will revolve around cardiovascular disease, cancer and brain injury in infants due to shaken baby syndrome.
In other news from the AACC meeting:
• A series of research reports over the past two decades has spawned interest in the use of the blood concentration of C-reactive protein (CRP) to predict a first coronary event. Measurement of very low concentrations of CRP has gained popularity as a potential new means for predicting the risk of future cardiac complications. The application has been made possible with the development of high-sensitivity CRP (hsCRP) assays that can measure the typically low concentrations of CRP that may suggest impending cardiac dysfunction.
Gary Myers, PhD, chief of the clinical chemistry branch of the Centers for Disease Control and Prevention (Atlanta) looked at findings on this relationship in a presentation titled "CRP and Lp-PLA2 as Markers of Cardiovascular Disease and Stroke."
Inflammation is pivotal in all phases of atherosclerosis. Among the numerous inflammatory biomarkers, the largest amount of published data supports a role for CRP as a robust and independent risk marker in the prediction of primary and secondary adverse cardiovascular events. In addition to being a risk marker, there is significant evidence indicating that CRP may indeed participate in atherogenesis.
• Agilent Technologies (Santa Clara, California) reported the availability of the Hycor Ultra-Sensitive EIA System for allergen-specific IgE. The Hycor Ultra-Sensitive EIA System is FDA-cleared for quantitative determination of specific IgE.
The system provides quantitative specific IgE detection with testing capacity sized for moderate to higher-volume labs. It has been designed to offer laboratories an overall cost-per-test advantage over alternative methods.
"Hycor has a tradition of providing high-quality allergy testing systems that enable labs to provide physicians with accurate results in a way that is cost effective," said Skip Thune, Hycor's general manager. "The new system has the throughput capacity to allow us to offer the Hycor cost-effective specific IgE testing solution to larger allergy testing customers that our other systems were too small to properly address."
The new system combines the precision and accuracy of fully automated robotic reagent dispensing with a newly formulated high-sensitivity assay design.
• Separation Technology (Altamonte Springs, Florida) launched a new cytology centrifuge with the power and features of a full-size unit, but in a compact size. The centrifuge is used in hospital cytology, microbiology and hematology departments to study cells. The SlidePrep Plus addresses the needs for labs where cost containment is critical at a cost of $4,600, about half the price of full-size centrifuges. Although the new device was displayed at AACC, it won't be commercially launched until 4Q09.
• Abbott (Abbott Park, Illinois) unveiled its new PLEX-ID system currently in development for detecting and characterizing a wide range of pathogens, including infectious agents commonly transmitted in hospitals and other clinical sites. PLEX-ID is the next generation of Abbott's Ibis T5000 biosensor system
Currently intended to be for research use only, PLEX-ID is a high-throughput technology that simultaneously enables identification and recognition of emerging organisms using a unique combination of both PCR (polymerase chain reaction) and mass spectrometry analysis for detection of microbes.
The system is designed to address a significant unmet clinical need by providing results in six to seven hours instead of three or more days as is required with culturing methods.
The PLEX-ID is expected to receive the CE mark later this year.