A Diagnostics & Imaging Staff Report

B-K Medical (Herlev, Denmark) has launched the Pro Focus OR ultrasound system, which it says is the only fully featured operating room suite that works as an integrated part of the OR.

The company said the Pro Focus system is designed to be a permanent part of the OR, mounted on the OR boom. The scanner's flat-screen monitor and control panel are mounted on flexible arms that can be positioned for best use. With the system, BK said, "surgeons can access the ultrasound capabilities they need during surgery quickly and easily."

It added that because the system is off the floor, "the Pro Focus OR affords the OR staff their accustomed freedom of movement within the sterile area. The system's simplicity also translates into a reduction in cleaning and preparation time, for quicker turnaround."

Also setting the Pro Focus OR system apart from more conventional ultrasound systems, the company said, "is that it can accommodate the full range of dedicated surgical transducers. Compatible with the new, high-frequency 8814 intraoperative surgical biplane transducer and 8815 interventional transducer, the scanner provides unprecedented accuracy to interventional intraoperative ultrasound."

Michael Brock, B-K Medical's president, said, "The Pro Focus OR is intended to take surgical ultrasound to a new level; it is designed for professionals and the OR of the future. With this system, we are not only able to offer hospitals and clinics the most advanced, dedicated surgical ultrasound system on the market today, but also a cost-effective way to configure and streamline their operating rooms."

The company said a "unique" contrast imaging package and "seamlessly integrated" 3-D also are available, "making the system an invaluable tool for surgical decision-making and patient management."

B-K Medical, a subsidiary of Analogic (Peabody, Massachusetts), said it is a "world leader in developing ultrasound scanners designed for surgery and for the investigation of urological disorders." The product line also includes scanners for other applications, such as gynecological examinations, fetal scanning and radiology.

Chlamydia test in development by Enigma

Enigma Diagnostics (Porton Down, UK), a developer of rapid molecular diagnostics and detection systems, reported completion of a project commissioned by the UK's Defense Science and Technology Laboratory to develop a rapid, point-of-care diagnostic system for screening and diagnosis of chlamydia infections, the most common treatable sexually transmitted infection (STI) in the UK.

The project was designed to meet the needs of the UK National Chlamydia Screening Program (NCSP), part of the National Strategy for Sexual Health and HIV.

Enigma has developed a specific DNA assay, reagents and instrumentation capable of rapidly detecting Chlamydia trachomatis DNA from multiple urine and swab samples at the point of care. The company said feasibility of the assay has been proven in the laboratory and product specifications have been validated.

The new system will be based on Enigma's fully-automated diagnostics platform, which uses real-time polymerase chain reaction (PCR) technology to detect bacterial target DNA in samples and provides definitive results in a matter of minutes, enabling immediate treatment as necessary.

The company said the system also will be simple to use, requiring minimal training and experience, and will provide laboratory-quality results, reducing the need for samples to be sent to a laboratory.

Chairman John McKinley said, "This contract with the UK government demonstrates the utility of Enigma's innovative molecular diagnostics and detection technology. We will develop a system that rapidly and simply delivers laboratory-quality results in a clinical environment and... meets the needs of the UK National Chlamydia Screening Program, where speed, sensitivity and simplicity are of crucial importance."

Enigma has an exclusive license from the Defense Science Technology Laboratory to a portfolio of patents that represent more than 15 years of Ministry of Defense-funded research.

The company's own R&D activities have added additional patents and design rights based on its technologies to generate a portfolio in excess of 40 worldwide patents and patent applications dedicated to real-time PCR and wider rapid technologies. More than 25 of these patents are granted in core territories such as the U.S., EU and Japan.

Japanese distribution deal for Spectral

Spectral Diagnostics (Toronto) said it has entered into an exclusive distribution agreement in Japan with Toray Medical for Spectral's EAA diagnostic system.

Toray Medical will market and sell the EAA Endotoxin Activity Assay for the detection of endotoxemia and the subsequent risk for sepsis in conjunction with its Toraymyxin blood purification device, which removes endotoxin from the bloodstream. Toray Medical also will distribute the EAA diagnostic as a stand-alone product.

"This new arrangement is a significant expansion of our existing alliance with Toray Medical, which over the past three years has focused on establishing the value of our EAA diagnostic in combination with Toray's blood purification device," said Dr. Paul Walker, president and CEO of Spectral Diagnostics. "This alliance will strengthen our presence in Japan and provide us with access to other Asian countries."

This is the third major distribution agreement for EAA that Spectral has signed in 2007.

China distribution accords for JJB

AMDL (Tustin, California), which through its wholly owned Jade Pharmaceutical (JPI) subsidiary is an international biopharma company developing pharmaceutical and diagnostic products, said that JPI's subsidiary, JJB, has signed set of regional distribution agreements in China for its new anti-aging and skin care injectable product under the brand name Goodnak.

The product is the first in a new line of anti-aging and skin-care products currently under development by JJB.

JJB signed exclusive, one-year renewable distribution and agency agreements with Changsha Hongli Co., Wenzhou Limeikang Trade and Xiamen Larry Beauty Technology Co. The agreements cover the key cities in Hunnan, Zhejiang and Fujian provinces in southern China that have a combined population of nearly 135 million.

The agreements require these new distributors to purchase a minimum of $7.12 million worth of the Goodnak product during the one-year period of the contracts.