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BacterioScan's FDA-Cleared UTI Test Provides Rapid Results to Aid Antibiotic Decisions


NEW YORK (360Dx) – With US Food and Drug Administration clearance in hand for its bacterial urinary tract infection testing platform, BacterioScan is focused on its commercial launch.

The company announced earlier this week that its system, called 216Dx, received FDA clearance. Providing results within three hours, the platform could address the fast-growing problem of antibiotic resistance.

As an important part of its product launch, BacterioScan has entered into a sales and distribution agreement for its 216Dx system with Fisher Healthcare, part of Thermo Fisher Scientific. "We've been working with Fisher on initial customer interactions and planning for this product for more than a year," Dana Marshall, BacterioScan's president and CEO, said in an interview.

He noted that Fisher Healthcare is "very familiar" with its UTI product. The companies are working together to place instruments in laboratories following the FDA clearance. They had already deployed pre-clearance placements in hospitals starting 18 months ago as part of a process to develop BacterioScan's clinical protocols for the UTI test, Marshall said.

The company is focused in the near- and medium-term on "satisfying the lab market and gaining acceptance" of the UTI test in clinical microbiology labs, he said.

The process to diagnose UTIs, one of the most common infections, normally takes a few days to complete, which contributes to antibiotic resistance, Marshall said, adding that the 216Dx platform allows clinicians to quickly identify the large proportion of patients who test negative for UTIs.

BacterioScan's objective is to remove those negative samples, up to 75 percent of all samples, from the laboratory workflow and enable labs to allocate skilled labor to test the portion of samples that are positive, Marshall said.

In operation, a single-use disposable cartridge with a liquid sample sits in the 216Dx instrument, which incubates the sample. By counting and analyzing particles using laser scatter patterns, the platform monitors whether bacteria are growing. It is sensitive to very low concentrations of bacteria and very small changes in bacterial density, Marshall said, adding, "Because it has this general type of capability, it's also a very good platform for looking at bacteria in other bodily fluids. Although the clinical protocols are different and the media are different …the basic idea is the same."

"To stay ahead of continuously emerging antibiotic resistance, we need rapid diagnostic tests that can indicate the presence or absence of bacteria in clinical specimens," Stephen Brecher, director of microbiology at the VA Boston Health Care System, said in an interview.

"Appropriate use of the BacterioScan 216DX should help reduce inappropriate antibiotic use, help reduce unnecessary cultures, reduce costs, and improve patient care," said Brecher, who serves on BacterioScan's clinical advisory board.

The device can determine within three hours if a urine sample has significant numbers of bacteria or not, he said. If the test is deemed negative within three hours, the patient does not likely have a UTI, and neither a culture nor antibiotic are needed. On the other hand, if the test is positive, a culture is needed to accurately identify the bacteria and the antibiotics that should work, which takes two to three days, Brecher noted.

In clinical studies involving more than 3,000 patients, the UTI assay identified patients with bacterial infections at a sensitivity rate of 98.6 percent and a negative predictive value of 99.6 percent, providing certainty to lab clinicians that they have rapidly and reliably detected a urinary tract infection, Marshall said.

UTI testing is labor-intensive and involves manual culturing that typically requires two days to yield a result, he noted. "The current process for diagnosing UTI in the laboratory is typically blood agar plating, which hasn't been modernized for about 40 years," Marshall said, adding that it involves incubating overnight and culturing a patient's urine sample, and having a trained technician interpret the results.

UTIs are among the most common infections and responsible for an estimated 10.5 million emergency department visits in the US annually. Estimates place the number of people affected by the condition at around 150 million each year.

Most UTIs stay in the bladder before passing out of the body, but if they are not treated promptly, bacteria can travel to the kidneys and cause pyelonephritis, a kidney infection that can produce back pain and fever. UTIs can be effectively treated with antibiotics but figuring out whether the patient sample is positive can be the most problematic part of diagnosis and treatment, Marshall said.

He noted that the BacterioScan instrument consists of a "very simple set of hardware" that uses components comparable to the contents of a barcode scanner. As a result, although the clinical protocols have not yet been developed or trials completed for use of the platform in a near-patient or point-of-care setting, the system could be adapted for that use, he said, adding, "Nothing in our system precludes it from being deployed in the longer term at a MinuteClinic or for home care in testing patients that are particularly susceptible to UTIs or have resistance to treatments."

Other types of tests have a big part to play in the clinical workflow established to detect and treat urinary tract infections, he said, adding that molecular and proteomic assays are needed, for example, to identify pathogens responsible for infections in samples that are positive based on the urine test.

However, health systems are saving money each time a test that is negative is not moved to identification and AST testing, and the patient is benefiting from not having taken an antibiotic that didn't work, he noted. In this scenario, clinicians are eliminating most of the testing on negative samples, Marshall said, adding, "If you are able to reduce the number of samples by half, you've cut the cost of the AST process in half."

Further, because the firm's detection system operates quickly it holds the potential to effectively guide therapeutic responses for infected patients, Marshall said. 

The St. Louis-based firm has been in existence and developing its platform since 2012. It purchased and adapted technology invented around 2005 by Israeli scientists who were working on the use of lasers in missile defense and adapted them to detect bacteria in urine. BacterioScan has since been working to develop the technology for UTIs and other applications.

The firm is privately held and primarily financed by angel investors, and it has received some funding from Missouri-based biotech organizations, Marshall said.

In January, the firm announced that it had received a $211,000 National Institutes of Health grant to develop a test for rapid detection of bloodstream infections. The NIH funding is being applied to develop techniques for sample preparation to rapidly detect infections, such as sepsis, directly from patient specimens on the 216Dx platform. Testing for bloodstream infections can take from a few days to a week to complete, but BacterioScan said it hopes to significantly reduce that time, partly by eliminating blood cultures. The firm said that after bloodstream pathogen identification, its technology could eventually be used to reduce antimicrobial susceptibility testing to less than eight hours.

Competition is limited because of the speed with which the firm's platform can detect UTIs, but some labs are looking to increase automation of traditional testing processes, Marshall said. In the context of testing blood samples, T2 Biosystems, a firm with a direct-from-blood diagnostic platform, could become part of its competitive ecosystem, he said. Further, Accelerate Diagnostics' pathogen identification and antimicrobial susceptibility testing platform could become a competing system if BacterioScan successfully completes development and clinical trials for a future, planned AST test on its 216Dx platform.