Abbott to collaborate on rapid molecular test to identify serious infections in bones and joint

Abbott announced today it will collaborate with Genetics Laboratory, Inc. (GenLab) on the development of a molecular diagnostic test that will be designed to rapidly detect microorganisms that cause orthopedic infections. Under terms of the agreement, Abbott, in conjunction with GenLab, will develop and commercialize the new assay for use on the PLEX-ID™ automated microbial identification system. In the United States, PLEX-ID is currently intended only for non-diagnostic use, but assays are now being developed for future clinical diagnostic uses.

PLEX-ID has the ability to rapidly identify a broad variety of microorganisms. The system is capable of generating results within five to six hours in contrast to other methods, which may take several days or longer for positive identification.

“Bacteria, particularly antibiotic-resistant species such as MRSA, are very dangerous in orthopedic patients because the bacterial colonies attach to the artificial surfaces of the implants,” said Gerhard Maale, M.D., an orthopedic oncologic surgeon and an expert in orthopedic infections in the Dallas-Ft.Worth area. Dr. Maale will also serve as the medical director for the Abbott-GenLab collaboration.

“A molecular diagnostic test designed to detect microorganisms that cause orthopedic infections, running on the PLEX-ID, could have the ability to determine which pathogens are responsible for an infection while assessing the genetic composition and potentially antibiotic resistance,” Dr. Maale said. “This could be a major step forward in diagnosing and treating serious infections in artificial joint recipients, with the potential to provide important information to physicians that they could use to save treatment costs and improve the quality of life for these patients.”

Bacterial infections can occur during hip and knee replacement procedures and are difficult to diagnose and treat. Bacteria, such as MRSA, form slimy colonies known as biofilms in artificial joints and can be resistant to antibiotics. Biofilms are difficult to identify using traditional bacterial culture test methods since the organisms clump together and do not grow well for positive identification, often leaving physicians with very little information to guide their treatment decisions. According to The New England Journal of Medicine, about 800,000 knee and hip replacement procedures are performed annually in the United States, and complications related to infections occur in approximately 2 percent of those procedures. In addition, more than 70,000 joint revisions are performed annually in the United States, with greater than 15 percent of hip and 25 percent of knee revisions caused by infections. Revisions are often more expensive than the original procedure.

About PLEX-ID

Currently intended for non-diagnostic use in the United States, PLEX-ID is the only high-throughput technology that offers rapid and broad identification of bacteria, viruses, fungi, certain parasites, and also provides information on drug resistance, virulence, and strain type. The system employs a combination of molecular technologies, including polymerase chain reaction (PCR) for gene amplification and mass spectrometry analysis to rapidly characterize known and unknown organisms. The test for bone and joint infections will be among other tests the company is currently developing for use in serious clinical infections, the first of which is pending CE marking in the European Union. In 2009, PLEX-ID was recognized by both The Scientist and the Wall Street Journal as a top scientific innovation of the year. The Scientist honored the system because it can detect and characterize a broad range of microorganisms in any given sample.