A Diagnostics & Imaging Week

GeneLink (Jersey City, New Jersey) reported that the Australian patent office issued it a patent for its oxidative stress test, entitled "Kits and methods for assessing oxidative stress," the second patent it has received for a family of applications filed by GeneLink in the U.S. and abroad.

GeneLink's proprietary DNA test for oxidative stress is used to predict an individual's risk for a variety of age-associated conditions. Oxidative stress occurs when there is an accumulation of destructive molecules called free radicals that damage the integrity of the cells by destroying proteins and DNA. The oxidative stress theory suggests that degenerative diseases associated with aging may be attributed to the effects of these free radicals on the body's cells.

"GeneLink believes that grant of this Australian patent further confirms GeneLink's confidence in the commercial potential of its technology," said Monte Taylor, Jr., acting CEO of GeneLink. "In addition to the Oxidative Stress Test, GeneLink has expanded its genetic test offerings to include: Dermagenetics, a skin health panel; Comprehensive Cardio Panel; Lipid Metabolism Panel; Bone Density Panel; and CoQ10 Efficiency."

Based on the analysis of key genes, GeneLink's tests provide information that enables customization of nutritional and skin-care products, as well as development of health maintenance care regimens personalized to meet a person's individual needs.

GeneLink offers genetic tests to companies that distribute to the $100 billion-plus healthcare, nutritional supplement and skin-care industries. Through its subsidiary, Dermagenetics, it markets its DNA UltraCustom system of "genetically guided" skin-care products to the spa and medi-spa industries.

PhotoCure grants rights to GE Healthcare

PhotoCure (Oslo, Norway) reported that it has provided exclusive licensing rights to GE Healthcare (Chalfont St. Giles, England), outside of the U.S. and the Nordic region, to market Hexvix (hexaminolevulinate), PhotoCure's optical molecular imaging agent used to diagnose and monitor bladder cancer.

PhotoCure manufactures the product and handles Nordic distribution, with GE Healthcare having an exclusive option to market the product in the U.S. The agreement also includes access by GE to other indications for Hexvix now under evaluation.

Hexvix has received approval for the diagnosis of bladder cancer in several European countries, with more expected "in the near future," it said.

Hexvix is not FDA-approved, but PhotoCure in June submitted a new drug application for it to the agency. The company said that, assuming approval, it would be the first optical molecular imaging agent of its kind available in the U.S.

"This is a great match. With its focus, strong market position in imaging and successful track record of launching new products, GE Healthcare is the ideal partner for establishing Hexvix as a tool in the diagnosis of bladder cancer," said Kjetil Hestdal, PhotoCure president and CEO.

"We believe our partnership with PhotoCure will result in significant patient benefit in the diagnosis and management of bladder cancer," said Daniel Peters, president of Medical Diagnostics at GE Healthcare.

PhotoCure says that optical imaging has the potential to provide new applications in the prevention and treatment of bladder cancer and other diseases. Optical imaging uses light to illuminate superficial tissue, such as bladder tissue. By combining this technology with an optical molecular imaging agent, tumors might be targeted more accurately. Optical imaging may enhance the diagnostic abilities of urologists and allow for improved patient care.

The American Cancer Society (Atlanta) estimates that 63,210 men and women (47,010 men and 16,200 women) will be diagnosed and that 13,180 men and women will die from cancer of the bladder in 2005.

PhotoCure is also developing photochemical internalization, a technology for light-directed drug delivery through its subsidiary PCI Biotech.

Vasamed's AcQtrac CE-marked

Vasamed (Minneapolis), a developer of non-invasive, hemodynamic assessment technology, reported receiving the CE mark for its new AcQtrac System which provides real-time measurements of hemodynamic parameters that allow physicians to manage a range of cardiovascular patients.

"Overall, heart disease is estimated to cost Europe EUR 169 billion annually," said Paulita LaPlante, president and CEO of Vasamed. "The AcQtrac System's rapid, non-invasive cardiovascular assessment can be a cost-effective alternative for a market focused on earlier diagnosis and treatment as part of their overall health policy objectives."

FDA-cleared earlier this year, the AcQtrac relies on a graphical waveform that represents the mechanical function of the cardiovascular system and provides information to quickly assess conditions such as congestive heart failure or to monitor treatment outcomes such as those provided by drug therapy.

Vasamed also makes the SensiLase PAD 3000 and Laserdopp PV2000 System for quantitative evaluation of microcirculatory perfusion in patients with chronic foot ulcers, diabetes and other peripheral arterial disease. Laser Doppler technology, coupled with algorithms to measure skin perfusion pressure and pulse volume, assist in evaluating microvascular health.

Minrad unveils new international pacts

Minrad International (Buffalo, New York) reported six new international contracts, four for inhalation anesthetics and two for its real-time, image-guided medical devices.

The company said that the contracts are expected to produce a minimum of more than $7 million in sales by 2008.

In the company's anesthesia and analgesia product line, it reported new agreements in Pakistan, Peru, South Africa and with an industrial customer requiring annual minimum purchases to remain exclusive of $5.3 million by 2008 and increase the number of company's anesthesia and analgesia agreements to 37 contracts. Anticipated totals under these agreements now represent $114 million during 2008.

Minrad also reported its first international image guidance contracts in Taiwan and in China, totaling $2.1 million by 2008. The company anticipates that it will begin signing international partnering agreements for its image guided line as it goes forward and will announce these quarterly, similar to what it has done in the anesthesia and analgesia product line.

Minrad is focused on developing systems for interventional pain management. Key product lines include real time image-guidance, anesthesia pharmaceuticals and a program to develop a conscious sedation drug/drug delivery system.