A Diagnostics & Imaging Week

Bio-Imaging Technologies (Orlando, Florida) and its Phoenix Data Systems division said it is rebranding the two companies under the name BioClinica, thereby completing the final stages of an operational merger that was begun a year ago.

According to the company, BioClinica combines electronic data capture (EDC) services and medical image management to offer a single, integrated solution that increases efficiency and decreases costs for pharmaceutical, biotech and medical device companies through all stages of clinical trials. BioClinica, as well, continues to provide traditional EDC and imaging core lab services to its customers.

"The new brand better represents what our customers require to succeed, integrated solutions that track and manage more of their clinical data," said Mark Weinstein, president/CEO of BioClinica. "The speed and accuracy of this combination helps to mend the current broken clinical trial process. We look forward to extending our Imaging Core Lab leadership with comprehensive EDC services, and helping life science companies to manage their clinical trials with greater efficiency, quality and improved data visibility."

According to BioClinica, medical imaging technologies generate more data than ever, requiring even more resources to manage and turn it into useful information. As the volume and the complexity of patient data increases exponentially, more expertise and better tools are required, from study start-up and initiation through data collection and the delivery of final results.

"We believe that the combination of Bio-Imaging and Phoenix Data Systems as BioClinica creates a powerful new voice in the clinical services space by combining superior customer service and expert consultative support for data image management and EDC... . BioClinica has an established history of reliability where many have failed," Weinstein said.

In other dealmaking activity:

• Perlegen Sciences (Mountain View, California), which makes genetic tests that correlate genetic variation to predisposition to disease and drug response, said it has entered a non-exclusive license agreement with Celera (Alameda, California) focused on a family of patents that covers methods of genetic analysis central to creating similar diagnostic products. The agreement grants Celera use of this Perlegen intellectual property as well as use of Perlegen's specific predictive genetic markers on chromosome 9p21 for coronary heart disease, to be included in products marketed by Celera.

Perlegen's genetic analysis intellectual property covers the combination of multi-loci markers to create diagnostic products for determining an individual's predisposition to multi-factorial disease or for ascertaining an appropriate course of treatment. It is expected to allow Celera to detect genetic markers for multi-factorial traits and tightly linked haplotype blocks, facilitate optimal matching of patient cases and controls, and provide methods for managing the massive data sets that accompany these analyses.

Celera said it would pay an upfront payment and royalties on certain sales of testing products. Additional financial terms of the agreement were not disclosed.

• Revolutions Medical (RevMed; Mount Pleasant, South Carolina) said it recently signed a worldwide exclusive license with Strategic Product Development for an image guided navigation system that incorporates high accuracy breast biopsies system (BBS) to conventional mammography systems which number more than 50,000 globally. This technology has already received FDA 510K clearance. According to RevMed, BBS facilitates accurate and fast non-palpable lesions and micro calcification localization in the treatment of breast cancer. It is low-cost, standalone stereotactic image-based system, which uses data from a pair of mammograms to enable radiologists to accurately position a localization needle or biopsy tool at the location of suspicious abnormalities in the patient's breast. Revolutions Medical believes that the BBS will offer significant advantages for the localization and biopsy of breast abnormalities. The system can also be modified to leverage existing popular biopsy tools. The technology can be used to provide a technology platform for future development including multi-modal breast imaging for the image fusion of MRI and X-Ray images, the company noted. The BBS will be modified to use Rev Med's safety syringe technology as well, the company said.

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