Accelr8 announces patent allowance for rapid bacterial diagnostic method

Accelr8 Technology Corporation has announced that it received notice of allowance on the first patent related to its BACcel rapid diagnostic platform.

The methods enable the BACcel system to quickly identify major multiple drug resistant (MDR) bacteria and their resistance mechanisms. Familiar examples of MDR bacteria, often called “superbugs” by the press, include MRSA (methicillin resistant Staphylococcus aureus), Acinetobacter, and Pseudomonas.

The BACcel system rapidly identifies bacteria and their major resistance mechanisms, but eliminates the need for cultures. Today's standard lab methods typically require 2-3 days to perform tests because they require extensive growth of bacterial cultures. The BACcel can identify and count bacteria within 2 hours after specimen access, and identify major resistance mechanisms within 6 hours.

The new patent covers methods used in the BACcel, and also claims alternative methods that a competitor might otherwise use to circumvent the BACcel's specific design. The innovative system extracts live bacteria directly from a patient specimen and immobilizes them on a surface. This method permits an automated microscope to measure the response of each individual cell during exposure to different test agents, such as identification antibodies or antibiotics. The patent addresses the fundamental set of methods necessary to track individual cells and their responses over time.

Research using the BACcel system demonstrates success with important types of MDR strains. MDR pathogens significantly increase mortality rates because they resist the antibiotics most often used for initial therapy. Serious infections require immediate treatment, and lab tests take too long to guide the initial choice of antibiotics. Because of widespread and complex drug resistance, therapy started without lab guidance typically proves inadequate in 20% to 40% of cases. Switching to adequate therapy as soon as the next day is too late to improve outcomes.

As an example of the BACcel system advantage, a recent Accelr8 study used a strain collection of “Staph ” ( Staphylococcus aureus ) provided by the CDC (US Centers for Disease Control and Prevention, www.cdc.gov). CDC scientists had selected this collection from clinical isolates that proved to be the most difficult to correctly identify and categorize. “Staph” is a common bacterium that most often causes simple skin infections. However, MDR strains have acquired genes for antibiotic resistance and other factors that make them deadly in certain circumstances. MRSA is a group of strains that resist all but a few antibiotics. The CDC published research earlier this year using this collection to compare the performance of all significant commercial diagnostic products and standard lab culturing methods used to identify MRSA.

Accelr8's scientists performed a study comparable to that of the CDC, using the same strain collection with BACcel lab prototypes. Without optimizing the test methods, the BACcel performed almost as well as the best existing commercial product but much faster. Accelr8's scientists also made some significant new observations of phenomena that are not seen with current methods. These observations form the basis of a new patent application filed by the company.

As another example, Accelr8 conducted a study on rapid identification of Acinetobacter. This organism has received recent press attention because personnel wounded by IEDs or combat in the Middle East show an extraordinarily high incidence of MDR Acinetobacter infections. In addition, MDR Acinetobacter causes periodic outbreaks in hospitals and is much more difficult to treat or eradicate than MRSA. Some medical experts believe that Acinetobacter and similar organisms present a greater and more imminent threat than MRSA. Strains that remain susceptible to only one or two antibiotics are increasingly common.

Accelr8's scientists have shown that the BACcel system can quickly and accurately identify multiple strains of Acinetobacter extracted from lung fluids.

According to David Howson, Accelr8' s president: “Allowance of our first broad methods patent confirms protection of our core intellectual property in rapid bacterial diagnostics. The timing could not be better, since we' re accelerating the pace of our research publication. We are now proving that the BACcel system has unique capabilities that have potentially great impact on clinical practice. As a result, we' ve seen corresponding increase in industry interest, helping move us toward our goal of attracting a commercial partner.”