A Medical Device Daily

Orion Genomics (St. Louis) said it has initiated a collaboration with researchers at University of Glasgow (Glasgow, Scotland) to discover novel epigenetic biomarkers for the development of tests that screen for cancer at an early stage and provide personalized information about how tumors are most effectively treated.

Under the collaboration, scientists at Orion and the University of Glasgow will use the company's methylation technologies to identify biomarkers useful in the detection and treatment of cancers of the lung, breast and ovaries.

“DNA methylation-based diagnostics have the potential to substantially change the way physicians first diagnose and later treat cancer patients,“ said Professor Robert Brown, PhD, of the University of Glasgow. “We are excited to collaborate with Orion Genomics, whose microarray and PCR technologies are at the forefront for methylation analysis, both for marker discovery and for applying methylation diagnostics in a clinical setting.“

The research will use Orion's DNA methylation technologies, including MethylScope microarrays and MethylScreen PCR assays. Methylation refers to naturally occurring chemical modifications of DNA that regulate gene function. Abnormal DNA methylation often is found on DNA from cancerous cells and is believed to impact a tumor's sensitivity to chemotherapeutic drugs.

The groups will compare patterns of DNA methylation from normal and tumor DNA to identify specific patterns of abnormal methylation that indicate the presence of cancer and provide information about its stage and type. Orion will develop diagnostics based on these patterns that detect trace amounts of methylated tumor DNA in easily accessed patient samples including blood serum, biopsies, and cell scrapes.

Nathan Lakey, CEO and president of Orion Genomics, said Brown is a leader in translation research. “Working together with clinical trial groups, ethics committees and with support from Cancer Research UK, [he] has carefully assembled tumor banks that will enable scientists in his lab, in collaboration with Orion, to find biomarkers for novel therapy selection and screening diagnostics and will expand Orion's exciting pipeline of diagnostic products.“

Orion said its MethylScreen technology “leverages biomarkers discovered using [the] MethylScope technology to develop a new class of oncology diagnostic kits.“

2Q close seen for MediCor/Biosil deal

MediCor Ltd. (Las Vegas) and British breast implant manufacturer Biosil Ltd. and supplier Nago Ltd. said last week that they have agreed to schedule the closing of MediCor's acquisition of Biosil and Nagor for 2Q06.

MediCor's chief operating officer, Jim McGhan, said, “The parties are actively working toward a successful close.“

The deal initially was reported early last fall (Medical Device Daily, Sept. 14, 2005). MediCor said at the time that, with the two purchases, it would control about 30% of the worldwide breast implant market, “excluding the U.S.“

It said the acquisition of the companies, combined with its existing Eurosilicone breast implant product line, would further strengthen the position of MediCor as the third-leading manufacturer and distributor of breast implants worldwide, trailing Inamed and Mentor (both Santa Barbara, California), which hold first and second position, respectively.

McGhan cited a recent British Association of Aesthetic Plastic Surgeons report that the UK experienced an approximate 51% increase in breast implant procedures in 2005, a market in which Nagor has a significant market presence. He said Nagor also has a solid base of “highly qualified“ international distribution partners worldwide.

“Given the dynamic market growth and distributor network already in place, we are anxious to begin building upon the current Biosil and Nagor employee bases and expanding operations in the Scotland, England and the Isle of Man facilities to meet future demand,“ he said.

Biosil manufactures silicone implants for the aesthetic, plastic and reconstructive surgery markets, including silicone gel and saline-filled breast implants, with both round and anatomical shapes and smooth or unique micro-textured surfaces.

The company also makes a range of other silicone devices, including tissue expanders, testicular implants, gluteal implants, calf implants, facial implants and scar management products. Biosil also has developed products within the anesthesia and colorectoral disciplines.

Nagor currently is a supplier of the breast implant products made by Biosil in about 60 countries throughout Europe, Asia, South America and Africa.

Biosil has about 90 employees in its two ISO-certified manufacturing facilities, both of which have added production capacity, thus, MediCor said, enhancing its ability to meet increased product demand and support new product introductions. It said John Alsop would continue as president and managing director of Nagor after the deal closes.

MediCor was founded by Chairman Donald McGhan, who is considered the pioneer of the modern breast implant industry. The company manufactures products for medical specialties in aesthetic, plastic and reconstructive surgery and dermatology markets.

Given gets reimbursement in Czech Republic

Given Imaging (Yokneam, Israel) said the Ministry of Health of the Czech Republic has issued a reimbursement policy for PillCam SB capsule endoscopy. The decision is effective immediately and provides reimbursement for some 7 million Czech citizens who are covered by the Vseobecna zdravotni pojistovna insurance company.

The policy covers reimbursement of PillCam SB for suspected small bowel disease, including bleeding, tumors and inflammatory bowel disease following a negative gastroscopy or colonoscopy. About 115 million Europeans now have access to PillCam SB capsule endoscopy.

“[This] reimbursement reflects growing recognition in European countries of the important role that PillCam SB plays in detecting and monitoring diseases of the small bowel,“ said Gavriel Meron, president and CEO of Given Imaging. “We continue to work closely with officials from the ministries of health in those countries where PillCam is not yet reimbursed and anticipate additional policies to be issued in 2006.“