Diagnostics & Imaging Week
and D&IWs

One of the top manufacturers of ultrasound scanners for veterinarians is rolling out a lightweight version for medical clinics.

The Imagyne scanner, introduced by ECM (Angouleme, France) in March, is PC-based and includes post-processing, full-color Doppler, pulsed-wave Doppler or triplex mode, and a 4-D display.

An export manager with the company, Eva Galmar, told Diagnostics & Imaging Week that CE-mark approval for selling the device in Europe is expected this month, but that ECM already has presented the Imagyne scanner at medical expos in China, Dubai, Russia and Turkey.

The European debut is set for Hospital Expo, which will be held in Paris at the end of May.

Imagyne will be offered in ECM's well-established market for diagnostics of farm animals and household pets, but the company said that with a minimal change to the scanner head and significant software adaption, the same hardware is appropriate for human use.

ECM developed the new scanner over several years to make it more powerful, more compact and "user-friendlier" than its current veterinarian line, it says.

The scanner can be fitted with four different probes for convex, micro-convex, phased array and linear abdominal. The rectal probe used by veterinarians is not offered with the medical line.

Galmar said ECM, the sole French manufacturer of ultrasound scanners, has carefully considered its entry into a fiercely competitive medical market dominated by multi-national giants.

She said the company already has booked orders for the medical version of the Iagyne scanner, thanks to the early introduction at medical expos in emerging markets, and that ECM is negotiating with distributors in all targeted markets, including the U.S.

ECM is an affiliate company of Noveko International (Montreal), an investor in medical equipment and supply manufacturers.

Compugen reports new lung cancer biomarker

Compugen (Tel Aviv, Israel) reported the discovery and verification of CGEN-438, a potential blood-based biomarker for lung cancer. The company described CGEN-438 as "a novel splice variant peptide of delta-like protein 3 precursor (DLL3)." The peptide is secreted from the cell into the bloodstream, whereas the previously known DLL3 is a protein located on the cell membrane.

Compugen said initial clinical evidence indicates that the molecule "could potentially serve as both a serum biomarker for the diagnosis of small-cell lung cancer and as a component in a biomarker combination for the diagnosis of non-small cell lung cancer patients."

Using a test developed by Compugen to detect CGEN-438 in serum, the blood levels of the peptide were measured in about 40 lung cancer patients and healthy individuals. The company said CGEN-438 concentrations detected in serum samples of small-cell lung cancer patients were higher than those detected in controls, demonstrating its potential to become a diagnostic biomarker for small-cell lung cancer.

It said it "also was evident that CGEN-438 is expressed to a large extent in certain non-small cell lung cancer serum samples and therefore may be used in a biomarker combination test for the diagnosis of non-small cell lung cancer as well."

Compugen said it has filed a patent application covering the biomarker.

CGEN-438 is one of a group of possible cancer and cardiovascular biomarkers which was initially predicted in silico using Compugen's immunoassay computational discovery platform, and then further validated experimentally.

Anat Cohen-Dayag, PhD, VP of diagnostic biomarkers and drug targets at the Israeli company., said, "In this particular case, although the peptide is a splice variant of DLL3 protein, it shares no sequence similarity to DLL3, thus further demonstrating the unique predictive power of this specific platform and of our in silico prediction and selection discovery capability in general."

He said Compugen will further use the platform "both in our own discovery activities and in collaboration with partners."

1st Australian sale of Fonar Upright MRI

Fonar (Melville, New York) reported a sale of its Upright Multi-Position MRI scanner to a group medical practice in Australia. Fonar said that Australia represents a new market for Fonar, noting that only about 100 MRI scanners serve that country's population of some 20 million.

Raymond Damadian, Fonar's founder and president, said the sale in Australia "is just one more indication of the enormous future of [our] Upright technology." He said that many patients have come to the U.S. from Australia to be scanned on the Upright MRI. "Physicians and patients realize that they need the unique advantages of this advanced weight-bearing multi-position technology."

Damadian said that an MRI scan performed while the patient is lying down "doesn't allow physicians to see the patient's spine and other extremities in the positions the patient experiences pain."

For instance, he said, "if a person's neck hurts only when he or she flexes, the problem cannot be properly diagnosed with an MRI when the patient is lying down and symptoms are absent." In fact, according to Damadian, "a static, recumbent, non-weight-bearing scan may not visualize any pathology at all."

And even if the recumbent scan shows "something," he said, "the physician still must know the full extent of the pathology when the patient flexes and extends his/her neck. This relative blindness of the surgeon's ability to visualize the complete dynamic behavior of the patient's problem in its full range of motion can lead to less than optimal surgical results."

Damadian said the company's Upright Multi-Position MRI "enables surgeons to achieve optimal surgical outcomes."

Fonar said the Upright MRI "enables the ideal patient experience," as the patient "walks into the MRI, sits down and watches a 42" flat-screen TV as the scan is being performed."

The company said it expects to install the newly sold MRI to the unnamed Australian physician group during the current calendar year.

Invitrogen to distribute Sequenom's MassARRAY

Sequenom (San Diego), a provider of genetic analysis solutions, has entered into an agreement with Invitrogen (Carlsbad, California) under which Invitrogen will be the exclusive distributor for Sequenom's MassARRAY systems and consumable products in Central and South America. Financial terms of the agreement were not disclosed.

"Among our top priorities is expanding our geographic reach and this agreement provides us with an entrée into Central and South America, regions where we see a substantial opportunity but have had little exposure," said Michael Monko, Sequenom senior VP, sales & marketing.

Separately, Sequenom reported the sale of its first MassARRAY system in South America. The system was sold to a sugar cane consortium to be used in biofuel research and development in Brazil.

Sugar cane is a highly efficient raw material for the production of ethanol and is available in abundance in Brazil. Sequenom's technology will be used as part of an effort to engineer an even more productive line of sugarcane for ethanol production.

The MassARRAY system delivers specific data from complex biological samples and from genetic target materials available only in trace amounts.

Czech, please — SpectraScience signs distributor

SpectraScience (San Diego) said it has established a distribution partnership in the Czech Republic through the Almeda Company (Prague), a firm that has specialized in medical device sales in the region for almost two decades.

Michel Vaudry, SpectraScience's director of international sales, said, "the Czech Republic is attractive on many fronts as an entry point into the European market for our WavSTAT System, both for its aging population and its established $1.2 billion medical device market. In addition, the Czech Republic has one of the highest incidences of colorectal cancer in the world."

He added that SpectraScience is exploring additions to its export sales team in other European countries, including Italy, Germany and France.

The WavSTAT System uses light to optically scan tissue and provide a physician with an immediate analysis.