The article previously stated that a PLOS One article described the Reveal system as being able to identify a microbe's species. In fact, the article described a different Specific product. We regret the error.
NEW YORK – With a recent investment of $12.5 million, microbiology firm Specific Diagnostics aims to launch its antibiotic susceptibility platform that determines the antibiogram of a patient's blood culture in five hours, significantly less time than other systems currently on the market.
The company's Reveal system uses a patented small molecule sensor array to test directly from positive blood culture samples and obtain a profile of the volatile organic compounds that are emitted during growth of the bacteria, and then measures which antibiotics will stop the bacteria from growing. Depending on whether a Gram stain is positive or negative, the system evaluates 25 different drugs for each, helping guide clinicians to the correct therapeutic treatments.
The Mountain View, California-based firm has picked four clinical study sites in France, Germany, and the United Kingdom, along with six in the US, and expects the European studies to begin early in Q1 2020, said CEO Paul Rhodes in an interview. If everything goes as planned, the company said it hopes to declare CE-IVD registration by Q2 2020. The US studies will follow the European studies, and the company hopes to submit for 510(k) clearance to the US Food and Drug Administration in the second half of 2020. Depending on the FDA's review of Specific's clinical study data, the company plans an assay with broad species and antibiotic coverage, Rhodes said.
Accelerate Diagnostics has a similar platform that's already been FDA-cleared and is on the market, but according to Rhodes, Specific's technology brings faster speeds – which can make a significant difference in bloodstream infections, where mortality rates increase hourly.
Accelerate's Pheno system takes on average seven hours to measure antibiotic susceptibility, while Specific's takes five hours, meaning clinicians will likely still be on the same shift when the results are finished, Rhodes said. This faster turnaround time comes from the sensors' ability to respond to volatile organic compounds that are emitted before cell division.
Chad Brueck, Accelerate's head of global marketing and strategy, said there was no data on Specific's small molecule sensor array's ability to detect phenotypic antimicrobial susceptibility and very limited analytical or clinical data available on the technology's ability to perform identification. In contrast, Brueck said, the Acclerate Pheno system is actively being used to reduce the time to optimal antimicrobial therapy for patients. Data was also recently presented at IDWeek in Washington DC last week that demonstrated Pheno's ability to rapidly identify organisms, leading to faster changes in antibiotic therapy for Gram-negative bacteremia.
Specific hasn't set a price for its assay, but Rhodes said the Reveal test will likely be less than half the price of Accelerate's.
According to Specific, the minimum inhibitory concentration determination of the Reveal system also meets the accuracy levels of gold standard broth microdilution methods.
There have been multiple studies on Specific's sensor array, including one from the Royal Society of Chemistry in 2016 that found the colorimetric sensor array (CSA) can quickly and accurately determine the species of bacteria in a blood agar plate. In 1,894 trials, 15 pathogenic bacterial species were identified with 91 percent sensitivity and 99.4 percent specificity within three hours of detection.
When and if Reveal hits the market, it will be Specific's first commercialized product, but the firm has others in its pipeline. The company also has a blood culture system and a smart tuberculosis culture system in active prototype development that can not only detect growth occurring but can also determine other identification information about the disease.
Although the company's first application of its technology was for the smart blood culture system, in the fall of 2016 the firm made the decision to focus its efforts on rapid susceptibility, due to a perceived need in the industry.
"As a small company, we want to focus on executing this product very well and supporting the customers once it's introduced," said Rhodes. "We made the decision to focus on this because the need was very keen for a product with the characteristics that ours has."
The firm recently secured $12.5 million in funding from venture capital firm Telegraph Hill Partners to support Reveal's commercialization, and it was previously funded by the National Institutes of Health and Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a $455 million fund with a focus on antibiotic resistant bacteria. The fund, created by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority, originally provided $1.7 million to the company in April 2018. In March 2019, Specific received another $1.7 million in second-stage funding.
Specific has received more than $20 million in grants from the NIH supporting the development of its platforms.
The company has also partnered with the Foundation for Innovative New Diagnostics to "enable solutions for diagnosis of bloodstream infections around the globe," according to Specific's website. The nonprofit aims to help develop and deliver diagnostics technologies to low-income countries. The collaboration was about determining the features required for a blood culture system to work in the developing world, Rhodes said.
Earlier this year, FIND joined CARB-X's Global Accelerator Network to provide expertise and services for CARB-X funded companies.