Medical Device Daily and Staff Reports

Biochip diagnostics developer Randox (Crumlin, Northern Ireland) said it is licensing multiplex polymerase chain reaction (PCR) technology from SeeGene (Rockville, Maryland/Seoul, South Korea) to develop high-throughput screening panels that will simultaneously detect a broad range of infectious pathogens.

Randox, which has recently expanded into molecular biology diagnostics developing its Biochip Array Technology (BAT) for multi-analyte assays for gene expression profiles, said the new capability with SeeGene technology broadens market potential even further.

"The Seegene application has massive capability for simultaneously detecting a large number of pathogens in a highly specific and sensitive fashion," Martin Crockard of Randox told Medical Device Daily from Seoul, where he was coordinating work with SeeGene.

Crockard said using the PCR platform allows even faint traces of a pathogen in a patient sample to be amplified to detectable levels for the Randox BAT readers.

The BAT panels are run through one of the Randox analyzing units that include the high throughput, fully automated Evidence, the medium throughput semi-automated Investigator and a near-patient automated redare called Multistat.

"This has huge implications in healthcare practice," he said, "it will facilitate precise identification of the implicated pathogenic organism causing the symptoms presented, ensuring correct treatment is given at the correct dose at the correct time."

Where diagnostic assays typically are used to test for a single pathogen, simultaneous testing for multiple pathogens eliminates the need to perform a sequence of tests to find the cause of infection.

The companies are focusing their first efforts to combine the proprietary technologies on tests for sexually transmitted infection (STI) and respiratory infections.

With the amplified samples, Randox's biochip array placed in the analysis platform can simultaneously detect up to 10 pathogens, viral and bacterial, from a single sample, including those that may not present symptoms.

"While asymptomatic infections may seem harmless, if unchecked, they may be passed on and many have implications, using the example of sexually transmitted diseases, for fertility both male and female," Crockard said.

"As more than one STI may be present in an individual, which is quite often the case, it makes sense to test for as many as possible at once, so that the treatment given completely removes any infections, rather than only those detected using single assays," he added.

"In the case of respiratory pathogens, the need is greater still for an effective multiplex assay, as rapid determination of infection may save lives, through immediate and correct treatment," Crockard said.

For the respiratory assay panel, the Radox BAT assesses 18 pathogens simultaneously. "This provides a very powerful tool in the fight against debilitating respiratory disorders," he said.

The terms of the agreement between the two privately held companies were not disclosed.

€1 million round for ProTip

ProTip (Strasbourg, France), a developer of prostheses and implants using porous titanium, with a special focus on ear, nose and throat applications, said it has completed an "A" round financing of €1 million. The funds come from new investors, including business angels and entrepreneurs from the life science and other sectors.

ProTip said it has raised some €2 million since its inception in 2004, including grants, loans and awards.

The company said the funding will enable it to finish the development of an artificial larynx and bring it to its first in man trial. ProTip said there is a significant clinical need for an artificial larynx, as there is no prosthesis available today, and said "thousands of patients worldwide could benefit from this type of medical implant."

"We believe this financing will take us to the completion of the design of this breakthrough prosthesis," said CEO Maurice B renger. "The artificial larynx will be the first major milestone in the development of ProTip. We have several other projects in an advanced development stage that will also address widespread unmet clinical needs."

Investor Jean Louis Berchet, an experienced entrepreneur, said, "We are very excited by the prospects for ProTip's artificial larynx and believe the blend of experience and skills present in the company's management team, coupled with [its] know-how in porous titanium technology, will be fully capable of bringing this product and others to market and providing relief for thousands of patients."

Polish distributor accord renewed

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) said it has renewed its distribution agreement with EDO-MED as its exclusive distributor in Poland.

EDO MED will continue to market and provide technical service support for the CT Laser Mammography (CTLM) system throughout that country, as well as to assist with and promote the ongoing research efforts utilizing CTLM technology at the Comprehensive Cancer Center in Gliwice, Poland, and other institutes and research centers.

IDSI said it will continue to collaborate with EDO MED to develop the CTLM clinical research program in Poland, providing support for hospitals using the system as part of their routine practice and research to further investigate additional usage of the system. The company also will provide assistance for EDO MED's sales and marketing initiatives.

"Poland continues to seek methods that can improve breast cancer detection," commented Jaroslaw Borkulak, president of EDO MED. "[The] CTLM technology complements our product base of innovative, well-established products. We see great potential for the CTLM system for women, both in Poland and internationally."

In Poland, the CTLM system is currently used at the Comprehensive Cancer Center, Maria Sklodowska-Curie Memorial Institute, and the Military Institute of Health Services in Gliwice and Warsaw.

The CTLM system is a breast imaging system that utilizes continuous wave laser technology and patented algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or breast compression. CTLM is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.

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