Medical Device Daily
And MDDs

Luminex (Austin, Texas) unveiled FlexMAP 3D, its next-generation bead-based multiplexing system, at the Annual Meeting of the American Association for Clinical Chemistry (AACC; Washington).

Luminex said that FlexMAP 3D will be able to simultaneously measure up to 500 analytes in a single microplate well, an increase from the 100-plex capabilities of Luminex’s current offerings. The higher multiplexing capabilities will enable users to broaden the types of testing performed using bead-based multiplexing.

Patrick Balthrop, president/CEO of Luminex, said, “We designed FlexMAP 3D for clinical reference labs, pharmaceutical labs and academic core labs that are interested in enhanced workflow and higher multiplexing capabilities while maintaining the advantages of the xMAP bead-based technology.”

The FlexMAP 3D system also will include digital technology, redesigned optics for improved assay performance, a dual syringe assembly to enhance throughput, an auto adjusting probe and software to enable automation, and the ability to use both 96 and 384 well plates.

The new system is powered by xPONENT 3D software and features an intuitive touch screen and a small footprint.

The Luminex systems analyzers are based on the principles of 3D bead arrays that offer uniformity and faster reaction times than 2D planar arrays, according to Luminex.

Currently in alpha testing, the company said that FlexMAP 3D is targeted for commercial available in 2008.

Also at the conference:

WhenVeraLight (Albuquerque, New Mexico) introduced its Scout DS at the annual conference of the American Diabetes Association last month, for light-based assessment of diabetes, the company said that the device was enthusiastically received.

And the company was expecting the same reaction to the system yesterday as the result of its presentation at the 2007 Clinical Lab Expo, co-sponsored by the American Association for Clinical Chemistry and the American Society for Clinical Laboratory Science (San Diego).

“At the ADA [conference] I thought it was well received,” John Maynard, VP of product development for Vera Light, told Medical Device Daily, speaking from the conference. “We’re looking forward to hear [further comments] when we get on the [AACC] show floor.”

The company was releasing interim results of a large-scale pivotal clinical trial showing that Scout DS diabetes screening system outperforms both the fasting plasma glucose (FPG) test and the A1C test as a rapid, non-invasive screen for pre-diabetes and Type 2 diabetes.

The results are consistent with the company’s earlier study and show that the desktop device outperformed FPG by 27% and A1C by 22%.

Scout DS is a one-minute experimental diabetes screening system that uses light to detect diabetes-related biomarkers found in skin regardless of color. The trial includes 1,850 subjects at risk for Type 2 Diabetes, and data collection has been completed at eight U.S. sites.

This phase of the trial is designed to assure its ability to predict abnormal glucose tolerance in a wide range of individuals.

The device weighs 10 pounds and has not yet been approved for use in the U.S. Scout is designed to test for diabetes in one minute as an alternative to those who might not want to have blood drawn via fingerstick or other blood draw.

Scout is able to detect abnormal concentrations of advanced glycation end products (AGEs), which correlate well with diabetes and pre-diabetes and are associated with the disease’s serious complications.

There have been some tweaks to Scout since MDD reported on the device in June.

Maynard said that the goal was to get feedback and as much information as possible from conference attendees.

“We made the cradle portion — where you lay your arm — we made that more robust,” Maynard said. From the user’s perspective it’s all minor changes but the changes help the machine perform significantly better.”

A calibration trial of 1,700 subjects at risk or Type 2 diabetes has completed data collection at eight sites. This phase of the trial is designed to assess its ability to predict abnormal glucose tolerance in a wide range of individuals.

In August 2007, the system will be undergoing further testing at 20 U.S. sites in 5,400 subjects at risk for Type 2 diabetes

In all cases, Scout DS is being compared to the gold standard Oral Glucose Tolerance Test (OGTT) as the reference method.

A study published in the May 2007 issue of Diabetes Care of the Scout DS prototype, involving 351 subjects, showed it significantly outperformed both FPG and A1C by detecting 29% more patients with Type 2 diabetes and impaired glucose tolerance (IGT) than FPG, and 17% more cases than A1C.

Further evaluation of a sub-cohort of the clinical data showed the Scout DS prototype was able to identify 78% more individuals with IGT than the FPG test and 47% more than the A1C test.

Although this was a limited early clinical trial of a prototype in a small number of patients, VeraLight is saying it can match this result in its large-scale trials with the commercially designed device.

After the subject places the palm-side of the forearm onto the cradle of the Scout DS, the device shines multiple wavelengths of light into the skin causing AGEs to emit fluorescent light that is measured by the machine. The instrument compensates for skin pigmentation so that performance is not diminished by skin coloration.

Analogous to a “diabetes odometer,” AGEs offer a sensitive metric for the cumulative damage the body endures due to the effects of abnormally high blood sugar and oxidative stress. AGEs harm the proteins that make up the blood vessels, connective tissue, and are thought to be major factors in aging and age-related chronic diseases.

Medical experts believe non-invasive skin detection of AGEs could replace the FPG test as the medical workhorse for screening people suspected of having diabetes.

The system’s software utilizes multivariate statistical techniques that are applied to the spectra to obtain a diabetes risk score.

The company says that with all diabetes screening methods, an additional test is required to confirm diagnosis. The company is slating U.S. market introduction of the device in the second half of 2008.