BARCELONA, Spain – Spanish molecular diagnostics startup DeepUll this past weekend unveiled its flagship molecular testing platform, UllCore, and first assay, the UllCore BSI Test, a one-hour, direct-from-blood multiplex PCR test targeting 95 percent of sepsis-causing pathogens and multiple antibiotic resistance genes.
The company is making its first public appearance at an industry exhibition as part of the European Society of Clinical Microbiology and Infectious Diseases global congress (ESCMID Global) being held here through Tuesday. It is a fitting venue for the Barcelona-based startup, which has a noticeably prominent exhibit at ESCMID Global. The company's exhibit is also starkly bereft of details, featuring only four of its platforms and a minimalist aesthetic.
"We haven't … really had a public persona, up until now, and [we] are going public, showing the world what we've got," said Wade Stevenson, DeepUll's relatively new chief marketing and sales officer. "We have a working version of the instrument, and we've been testing samples that we've collected from various hospitals here in Barcelona."
DeepUll's UllCore system is a white-and-black box about the size of a large air conditioner (a 100-by-75-cm footprint) with a prominent 21-inch touchscreen display. The platform fully automates testing, including total microbial DNA extraction, using blood sample volumes ranging from 0.1 mL to 10 mL, and offers continuous loading of up to eight samples. DeepUll claims the platform has an approximate 1-hour turnaround time.
Beyond that, the company remains relatively tight-lipped about some of the system's more proprietary aspects, offering up not much more information than it did in 2022 after it raised €13 million ($12.7 million at the time) in a Series B financing.
Stevenson said this week that the secret sauce of the system's performance is a "highly sensitive" two-step real-time PCR process that will allow it to detect "nonviable organisms, fastidious organisms, and even cell-free DNA."
Compared to the gold-standard blood culture workflow that is still currently favored by most laboratories for sepsis pathogen ID and antibiotic resistance, "it's going to be a night-and-day difference," Stevenson said.
"With blood culture, you put a sample in blood culture bottles, incubate it, and it takes 19 hours on average. Then you still have to spend another day to identify it and then another day after that to do susceptibility testing," Stevenson said. "We're going to circumvent that process. We're developing a molecular test that goes direct from blood to identify these 50 reportable results, which we believe will cover 95 percent of the pathogens that cause sepsis."
This includes a dozen Gram-positive bacteria (including multiple-species pan-assays for Staphylococcus), 20 Gram-negative bacteria (including a 98-species pan-assay for Enterobacterales), and several fungi and antibiotic-resistance genes.
"And it's an incredibly simple, easy test — you get your tube of blood, you scan it, you put it in the instrument," Stevenson said. "An hour later, you've got reportable results."
Compared to molecular blood culture identification panels offered by companies such as BioMérieux and Roche, which are performed on a positive blood culture bottle, the DeepUll platform is designed "to provide that exact same information 24 hours earlier" because it's direct from blood, Stevenson said. "In the world of sepsis … that's what we hope will be a game changer."
DeepUll's mission at ESCMID Global is to sign on early-access users and potential clinical validation and trial partners. It doesn't have any clinical testing data to speak of besides what it has collected internally. But the company certainly has industry credibility. It was founded in 2020 by CEO Jordi Carrera and Chief Technology Officer Rafel Bru Gibert, both of whom also cofounded Stat-Dx, which Qiagen acquired in 2018 to further develop the Stat-Dx syndromic testing platform into what is now its QiaStat-Dx product line.
In addition, Stevenson, hired this year, formerly held various roles at BioFire Diagnostics and the aforementioned BioMérieux, including North American VP for clinical marketing. The company also recently hired Chief Medical Officer Kimberle Chapin, a professor of medicine and of pathology and laboratory medicine at the Warren Alpert School of Medicine at Brown University and previously CMO at Cepheid.
The company also has additional tenuous ties to BioMérieux, as Mérieux Equity Partners (MEP) made an undisclosed seed investment in the company in 2020. Alexandre Mérieux, chairman and CEO of BioMérieux, is a MEP board member.
DeepUll is currently gearing up for another fundraising round, Stevenson said, but has raised over €40 million since the start of operations in 2020. It will likely use any new funding to support clinical studies of its platform and assay. DeepUll is aiming to commence those studies next year, assuming it is able to identify clinical trial site partners this year, Stevenson said.
The company also has not disclosed potential pricing, although it is obviously top of mind.
"One of the things that has impressed me about DeepUll is from the outset they have been very price conscious, and this has been taken into consideration as they've gone through development," Stevenson said. "We recognize that in order to have maximum impact, this thing has to be affordably priced. So we've got to price it in a way that suggests broad usage and within the financial reach of most hospital systems."
The company also wants to let prospective adopters know that it plans to build out a test menu beyond sepsis, but it is too early to speculate on what those areas might be. "We certainly have the technology, and the system shows all the signs of being able to handle additional sample types and additional sample volumes," Stevenson said. "We get [that] buying a platform that only does one test can be a hurdle for laboratories, and so we fully intend to have a pipeline of products beyond sepsis."