A Medical Device Daily

Clinical Data (Newton, Massachusetts) reported that its PGxHealth division has entered into a non-exclusive, sub-license agreement with Australia’s Victorian Clinical Genetics Services (VCGS; Victoria) to provide genetic testing for familial long QT syndrome (LQTS).

The agreement with VCGS — a not-for-profit subsidiary of the Murdoch Children’s Research Institute (Victoria), Australia’s largest children’s research institute — covers LQTS testing to individuals and families in Australia and New Zealand.

LQTS is an inherited disorder of the heart’s electrical system. It causes a sudden, unexpected, life-threatening type of ventricular tachycardia, and people who have LQTS are at risk for syncope and possibly sudden death, often at a young age.

John Schultz, senior VP of licensing and strategic development at PGxHealth, said, “Sudden arrhythmia death is a tragic occurrence. However, with today’s diagnostic tools and treatments, heart rhythm abnormalities are a manageable health condition. This test not only can aid in the diagnosis of LQTS and help determine whether family members are at risk but may also guide treatment options for those who have exhibited symptoms.”

He added: “By partnering with a world-famous institution such as the VCGS and Murdoch Children’s, we are confident that the test will be of the highest quality and made accessible to the community in the widest manner possible.”

Professor Agnes Bankier, director of the VCGS, said, “Our mission is to provide clinical and laboratory testing, as well as counseling and support to help people with genetic conditions make informed decisions about their health and well-being. This agreement supports our efforts to do so.”

PGxHealth is involved in the development, clinical validation and delivery of genomics-based tests, in particular of efficacy and safety biomarkers for appropriate drug utilization. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics.

Canadian approval for Cutera’s Pearl laser

Cutera (Brisbane, California), a provider of laser and other light-based aesthetic systems worldwide, reported approval by Health Canada for its new laser, Pearl, with proprietary YSGG technology. Pearl received FDA clearance in March and CE-mark approval in July.

Kevin Connors, president/CEO of Cutera, said the company will immediately begin shipping the Pearl system to Canada.

Pearl is a minimally-invasive laser designed to improve the appearance of wrinkles, uneven texture, age spots and sun damage with only one or two treatments and minimal downtime. It is the first application of the 2790 nm wavelength for cosmetic dermatology.

“I see Pearl as a big step forward in facial rejuvenation. There is nothing else like it on the market,” said Kevin Smith, MD, a dermatologist in practice in Ontario. “I can identify five to seven patients every day who will benefit from Pearl because it provides effective and safe results for treating people with fine lines, irregular color and other signs of sun damage.”

Cutera said that clinical data has shown that Pearl’s controlled thermal effect creates residual heat in the upper dermis that stimulates new collagen production. The company said it expects Pearl to become a leading skin-rejuvenation procedure because of its “patient-friendly approach and excellent clinical results.”

Pearl is available on Cutera’s multi-application Xeo platform, as an upgrade to all existing customers and as a stand-alone unit.

Japanese research center uses SameSpots

Nonlinear Dynamics (Newcastle Upon Tyne, UK) said that Japan’s National Cancer Research Institute (Tokyo) is using the company’s Progenesis SameSpots as part of its biomarker discovery program.

The company said that the National Cancer Research Institute adopted the technology to support its mission of advancing knowledge in cancer prevention, diagnosis and therapy for cancer control. “Progenesis SameSpots offers a major breakthrough in the analysis of 2-D single stain and DIGE images, creating new possibilities for 2-D-based proteomics research,” said Nonlinear Dynamics.

The image alignment of SameSpots offers users a streamlined, faster 2-D workflow, largely through the elimination of post-analysis editing, the company said. “This significantly speeds up the 2-D analysis process and reduces the subjectivity which user-operated editing introduces.”

Will Dracup, CEO of Nonlinear Dynamics, said, “Progenesis SameSpots was only introduced into the Asia/Pacific market late last year, so this result shows SameSpots technology can generate real impact with clinical relevance in a very short time.”

This comes from the company’s core emphasis on developing high-quality data analysis solutions. Nonlinear’s product line includes analysis software for 1D and 2D electrophoresis gels, mass spectrometry (MS) and LC-MS, as well as tools for multivariate statistical analysis. Those products serve the proteomics, genomics, biomarker discovery and clinical diagnostics sectors.

Taiwan firm in supply accord with NIMS

Non-Invasive Monitoring Systems (NIMS; North Bay Village, Florida) said it has entered into a product and development and supply agreement with SingLin Technology (Taichung, Taiwan).

SingLin will manufacture NIMS’ Exer-Rest motorized platform, which moves a supine subject repetitively head to foot about 140 times per minute. The motion platform has the appearance and functionality of either a cot or twin bed in standard and extra-long dimensions.

Exer-Rest is being tested in a controlled pilot study for temporary relief of musculoskeletal pain associated with osteoarthritis of the hips prior to the launch of a pivotal trial to be submitted to the FDA for approval to market in the U.S.

The Exer-Rest will be marketed and sold in the Canada, UK, Europe, South America and India by NIMS and in the Far East by SingLin. NIMS will receive a royalty on each device sold by SingLin.

Dr. Marvin Sackner, chairman of NIMS, said, “The Exer-Rest has the potential to serve as a non-invasive, drug-free, holistic alternative to drugs for the relief of the often debilitating pain of osteoarthritis. He said that SingLin also will manufacture NIMS’ Somno-Ease device.

CEO Gary Macleod said delivery to the public should begin in 1Q or 2Q of 2008.