A Medical Device Daily

Proteome Systems (Sydney, Australia) reported an “early outcome“ from its collaboration with the HighQ Foundation (New York) in identifying multiple biomarkers for Huntington's Disease (HD) using its Proteom discovery platforms.

It said that a two-year human study will now validate these markers which could then be used to accelerate the development of new drug treatments for HD and other neurodegenerative diseases, such as Alzheimer's and Parkinson's.

In the program, funded by the HighQ, Proteome said it discovered the proteins for HD using its ProteomIQ and BioinformatIQ platforms. These proteins found in human blood samples constitute potential biomarkers for detecting HD onset and progression.

In parallel with the HD biomarker validation program, Proteome will analyze blood samples collected from people with Parkinson's and Alzheimer's to investigate which of these biomarkers are useful to determine efficacy of drugs being developed; monitor progression of these diseases to administer the most effective drugs; and screen people for early disease onset.

Dr. Allan Tobin, scientific advisor to HighQ, said, “The identification of biomarkers that can be used to monitor the pathological changes that occur during HD is essential for the development of effective drug treatments.“

Currently, there are no drugs available to treat HD, and rapid drug development requires diagnostic biomarkers to determine drug efficacy.

Proteome and HighQ said they are considering patenting several of these proteins as candidate biomarkers of the onset and progression of neurodegenerative diseases, including HD.

HD is caused by a defect in the Huntington gene which genetically programs degeneration of neurons in certain areas of the brain, causing uncontrolled movements, loss of intellectual faculties and emotional disturbance. In the U.S., about 30,000 people have HD; estimates of its prevalence are about one in every 10,000 persons globally.

Those with the defective gene will develop this fatal disease usually between age 30 and 50. The disease can be diagnosed with a DNA test at birth, but only about 5% of suspected cases in the U.S. are diagnosed early because there is currently no way of determining when the disease will manifest, and no treatment is available.

Proteome offers diagnostics and therapeutics expertise in the fields of respiratory disease, neurobiology and aging, cancer and infectious diseases.

Cardiac Science reports Hungarian contract

Cardiac Science (Bothell, Washington), a developer of cardiac monitoring and defibrillation products, reported that the Hungarian National Police Department has selected its Powerheart automated external defibrillators (AEDs) for deployment in all of its police vehicles.

With the contract, 400 Powerheart AEDs will be supplied to the Hungarian National Police via Innomed Medical (Budapest), Cardiac Science's exclusive distributor in Hungary.

To date, 25 AED units have already been installed in Hungary's police vehicles, Cardiac Science said, with the remainder to be deployed early this year.

Dr. Major General Jozsef Hatala, director of public safety for the Hungarian National Police Department, called the deployment “a major step forward in our efforts to better protect our citizens. We're proud to be the first police department in Europe that will have access to these crucial AEDs at our fingertips.“

John Hinson, CEO of Cardiac Science, said the new contract “demonstrates the reach of our global distribution network and our capability to provide excellent installation support in international locations.“

First NAS Peacock headed for China

North American Scientific (NAS; Chatsworth, California) reported that it has delivered the first order for treatment planning software and ancillary products, as part of its recent approval for Peacock, to a major oncology hospital in the People's Republic of China.

The total value of the contract with the Oncology Hospital is about $390,000, with installation expected this month or next.

Peacock is the principal product of NAS's NOMOS subsidiary and is a serial tomotherapy system designed to treat various types of cancer with intensity modulated radiation therapy (IMRT). NAS received approval to market Peacock from the People's Republic of China State FDA in September.

L. Michael Cutrer, president and CEO of NAS, said, “Following our late September 2005 approval from the SFDA, we have initiated our sales and marketing efforts for the Peacock system and continue to pursue additional registrations in China for our BAT image guidance product, as well as our brachytherapy products.“

NAS said it is in the process of registering its BAT family of products for image-guided radiation therapy and Prospera, its I-125 brachytherapy seeds for the treatment of prostate cancer, in China.

New approvals

Cynosure (Westford, Massachusetts), a developer of lasers and pulsed light sources, reported receiving approval from the Korean FDA for its 2-in-1 laser hair removal system, the Apogee Elite. Cynosure said it will distribute the system through OrientMG (Seoul).

The Apogee Elite combines Alexandrite and Nd:YAG lasers within one system, making it suited for laser hair removal on all skin types. It is a multi-application system that can also be utilized to provide treatments such as Cynosure's LaserFACIAL for sun-damaged skin, as well as removal of leg and facial veins, and age spots.

Michael Davin, CEO and chairman of Cynosure, said, “With this new ability to bring the Elite's unique capabilities to physicians and aesthetic centers in South Korea, one of the largest Asian markets for medical devices, Cynosure has expanded its growth potential.“

CardioMag (Schenectady, New York) said it has received notice from China's State FDA that its Magnetocardiograph system has been approved for marketing. The device, which non-invasively detects the magnetic field generated by a person's electric activity in the heart, is already installed at the TEDA International Cardiovascular Hospital (Tianjin).

Carl Rosner, president and CEO, said the certification “will allow CardioMag to enter the very large Chinese hospital marketplace for both research and clinical patient applications. It is estimated that there are about 20,000 hospitals in all of China, of which up to 2,000 are potential customers.“

The MCG procedure, which takes less than 10 minutes to perform and requires injections or exposure to X-ray radiation, produces 1,000 field-mapping images per heartbeat.

Calypte Biomedical (Lake Oswego, Oregon) reported receiving notification from the Beijing Drug Administration that its application for approval in China of its Aware OMT (Oral) HIV-1/2 rapid test has been accepted.

Roger Gale, CEO and chairman of Calypte, termed China “one of the countries that may experience a significant spread of HIV unless the government can follow through on its plans to curtail the growth of this problem. China has an acknowledged testing gap and has officially announced plans to offer voluntary HIV testing to its entire 1.36 billion-population.“