A Medical Device Daily

Three Japanese companies – Daiichi Pure Chemicals, Toshiba and Toshiba Hokuto Electronics – have agreed to work together to promote in vitro DNA chip-based diagnostics, starting with diagnosis of the human papilloma virus (HPV).

Under an agreement reported recently in Tokyo, the three companies will direct Toshiba's capabilities in DNA chips and electrochemical DNA detection and analysis, and Daiichi Pure Chemicals' know-how in in vitro diagnosis toward further advances in DNA-based diagnostic systems.

DNA-based diagnosis gives care providers the potential to identify the presence or absence of specific strains of a virus in an individual, and to develop treatment regimes best suited to patients' DNA profiles.

Daiichi Pure Chemicals and Toshiba have collaborated in the development of a diagnostic system based on an electrochemical DNA detection chip since January 2004 and are now ready to make the transition to real-world application.

Toshiba Hokuto Electronics has supported development and prototype production and will take responsibility for manufacturing the commercialized DNA chip and detection system.

The new agreement among the companies further promotes that goal by defining the role of the three partners and selecting HPV as the first target application. Infection with HPV is the main cause of cervical cancer, the second-most-common cancer in women.

Daiichi Pure Chemicals, Toshiba and Toshiba Hokuto Electronics are focused on developing Japan's first in vitro diagnostic system for HPV based on an electrochemical DNA detection chip.

The companies noted that the main direction in DNA chip development previously focused on fluorescence detection technology that used a laser to irradiate a sample and then measures the resulting fluorescence. “Since the equipment is large and not easily portable, and the chip and screening process are both expensive, fluorescence detection is impractical for real-world application outside the research lab,” they said in their announcement of the collaboration.

The in vitro electrochemical detection methodology being developed by Toshiba allows for detection of DNA without the use of fluorescent or other labels and offers what the collaborators term “much easier operation and shorter analysis time than currently available methodologies.”

The equipment required also is much more compact and integrate with IT technologies, and more cost efficient, they said.

Mindray in China OEM deal on BioZ

CardioDynamics (San Diego), a developer of Impedance Cardiography (ICG) technology, reported an original equipment manufacturer (OEM) agreement with Shenzhen Mindray Bio-medical Electronics (Mindray; Shenzhen, China), the largest manufacturer of patient monitoring products in that country.

Under the terms of the agreement, Mindray will integrate CardioDynamics' BioZ ICG technology into its patient monitoring products, and CardioDynamics will receive a licensing fee for each BioZ ICG kit purchased by the Chinese company.

Michael Perry, CEO of CardioDynamics, said, “China has been our most successful international market. This OEM agreement . . . is important to our international growth initiatives. Through our OEM strategy, we are increasing global access to our BioZ ICG technology and increasing the recurring revenue content of our business.”

Internationally, the company's primary market has been in the hospital, where OEM integration agreements and hospital specialty distributors are integral to success.

Perry said, “Our agreement with Mindray is a continuation of our partnership strategy with industry leaders, including GE Healthcare [Waukesha, Wisconsin] and Philips Medical Systems [Andover, Massachusetts] and is key to driving continued market adoption of our proprietary BioZ ICG technology.”

Shenzhen Mindray is engaged in the manufacturing, marketing and selling of electro-medical equipment in the patient monitoring, laboratory instrument and medical ultrasound sectors.

Russia OK's Phase III trial recruitment

Biovest International (Worcester, Massachusetts) said it has received regulatory approval from the Russian Ministry of Health and Social Development to recruit patients for its ongoing Phase III clinical trial of its BiovaxID vaccine for the treatment of indolent follicular non-Hodgkin's lymphoma (NHL).

The company said the approval lists 14 of the most highly regarded clinical sites in the Russian Federation, including the Russian Cancer Scientific Center in Moscow and the St. Petersburg City Clinical Oncology Dispensary. Biovest said that during the next 18 months, it expects to recruit up to 175 patients from these sites.

Recruitment and logistics will be coordinated by ClinStar Europe.

Dr. Steve Arikian, Biovest chairman and CEO, said, “Our research indicates that there are a significant number of NHL patients eligible to participate in the testing of our potentially life-saving therapy. With the addition of these sites in the Russian Federation, and with other initiatives under way in the U.S., we feel . . . we are on track to complete enrollment as planned.”

NHL, a cancer of the lymphatic system, affects 65,000 new patients each year in the U.S. alone. BiovaxID, a targeted therapeutic that stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without causing damage to normal B-cell lymphocytes or to other healthy cells, is meant to serve as a complement to existing therapies.

Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals (Tampa, Florida).

Chinese distribution deal for BioMachines

BioMachines (Research Triangle Park, North Carolina), a maker of automation tools to accelerate drug discovery and development, has signed an exclusive distribution agreement with CapitalBio (Beijing, China) that expands the company's sales channel into China, Taiwan and Hong Kong.

“China is projected to be the fifth-largest pharmaceutical market by 2010, growing from a total size of $6 billion in 2002 to $24 billion in 2010 . . . driven by compelling economic growth and supported by a large and deep talent pool of life science researchers,” said Tom Larrichio, BioMachines' CEO. “We are focused on being a key part of that growing demand.”

He added that CapitalBio has “a great breadth and knowledge of the industry and is a market leader in Asia.”

“We are confident that there is a growing market in proteomics-based research and development,” said David Sun, senior vice president of business development and marketing at CapitalBio. He termed BioMachines' automated tools as “very nice additions to our total solution offering” in proteomics research.