Bio-Imaging finds profitable niche managing clinical trial images

Bio-Imaging Technologies of Newtown, PA, is capitalizing on the growing importance of data gathered in clinical trials to address the effectiveness and safety of imaging products with a banner year. The company has achieved-and anticipates continued-double-digit growth, according to Mark Weinstein, president and CEO.

Bio-Imaging specializes in digital processing and analysis of medical images taken during human clinical trials and, to a lesser extent, preclinical animal studies. The company is handling 91 studies for about 45 different clients. In 2000, it formed a new division, Bio-Imaging, ETC, that specializes in the education, training, and certification needs of medical imaging centers and staff.

The company’s niche in the imaging industry appears to be paying off with four straight quarters of record revenues. Third quarter 2001 revenues of $2.25 million were 44% higher than revenues from third quarter 2000. The number of active clients increased by 34% over the same period last year and the contracted/committed backlog grew by 37% over the previous year.

“More and more, regulatory authorities like the FDA want independent quality assurance centers looking at clinical trial data,” Weinstein said. “This is not meant to be negative against companies that coordinate the image data internally. But we’re absolutely blinded as to therapy. Large pharmaceuticals like Merck have all kinds of imaging needs, and we can handle the entire range of modalities.”

Since its founding in 1990, Bio-Imaging has broadened its purview. The company used to provide data management and technical consulting services for GE Medical Systems’ image-guided therapy program. That arrangement has ended and Bio-Imaging now works primarily with pharmaceutical companies.

New regulatory guidelines covering clinical images have helped boost the firm’s bottom line. Many centers cannot pass complicated audits of clinical trial image data management, according to Weinstein.

Working with medical researchers around the world, Bio-Imaging can spot which modalities are waxing and waning in popularity for clinical trials. The company has seen few trials involving interventional CT or MR. Interest in conventional nuclear medicine scans as a means for supporting clinical efficacy seems to be decreasing, while interest in PET is ticking upward.

“PET is coming on now, although we’re not seeing anyone using it in large-scale phase III trials, which is where our real value is,” Weinstein said.

The images produced by clinical trial centers may surprise those who believe DICOM standards are followed routinely.

“Less than 20% of the images we get from clinical trials are based on DICOM,” Weinstein said. “That goes against the notion in the imaging marketplace that everybody uses DICOM.”

Digital mammography has strong growth potential in clinical trials, he said. Bio-Imaging has been in contact with the National Cancer Institute about getting involved in the American College of Radiology Imaging Network (ACRIN) study to compare the diagnostic accuracy of digital mammography against screen-film mammography for breast cancer screening. ACRIN expects to enroll nearly 50,000 asymptomatic women at 20 centers in the U.S. and Canada.