ANAHEIM, CALIFORNIA – Clinical microbiology firm Pattern Bioscience received a vote of confidence for its rapid phenotypic antibiotic susceptibility system, winning the Disruptive Technology Award Competition at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo here on Monday.
The organization officially changed its name to the Association for Diagnostics & Laboratory Medicine during the conference.
Austin, Texas-based Pattern uses a combination of microfluidics and machine learning to analyze single bacterial cells directly from clinical samples, allowing it to both identify pathogens and conduct phenotypical antibiotic susceptibility testing without culturing.
According to Carey-Ann Burnham, Pattern's chief clinical officer, the company's platform can make an identification and assess antibiotic susceptibility in around four to six hours. Traditional methods can take two days or more.
The platform works by creating cell suspensions in which single cells are encapsulated in pico-volume droplets. These individual cells are loaded into a cartridge consumable in which a portion is exposed to an intracellular redox indicator and an extracellular pH indicator while another portion is exposed to the antibiotics of interest. In both cases, the instrument observes the cells' metabolic activity following exposure to these agents and, using machine learning, identifies the particular pathogens present and their antibiotic susceptibility based on these metabolic patterns.
Burnham noted that in addition to speed, the single-cell nature of the platform also makes it well suited for performing susceptibility testing on polymicrobial specimens.
Formerly known as Klaris Diagnostics, Pattern is developing as its lead product a test for pneumonia that Burnham told 360Dx would be targeted at patients with severe infections, "such as those in the intensive care unit." She said the test would likely use bronchoalveolar lavage and/or endotracheal aspirate samples.
The pneumonia assay received US Food and Drug Administration breakthrough device designation in 2021. Burnham said during her Disruptive Technology presentation that in two internally conducted, externally reviewed studies conducted by the company, the pneumonia test surpassed performance benchmarks required for FDA clearance in both organism identification and antimicrobial susceptibility.
Pattern is in the middle of a preclinical evaluation of the pneumonia test in which it has partnered with clinicians at Washington University in St. Louis (where Burnham was previously a clinical microbiologist and professor) and the Medical College of Wisconsin to look at roughly 400 respiratory samples, comparing the performance of its test to standard bacterial ID and susceptibility testing methods. That study will also look at the performance of the company's assay for assessing positive blood cultures, which is the second product in its pipeline.
Pattern is also planning a multicenter clinical study to support an FDA 510(k) submission of the pneumonia test that aims to analyze between 2,500 and 3,000 specimens.
Burnham said the company plans "to be flexible with our business model to suit various types of laboratory operations" including options to purchase the instrument as well as to obtain it via a consumables contract.
In April, Pattern announced the completion of a $28.7 million Series C financing round, which brought its total funding to date to $68 million.
Pattern's clinical microbiology technology took first prize from the competition's three judges, Joseph Bernardo, operating partner at private equity firm Linden Capital Partners; John Blackwood, founder of Horizon Dx; and Kelly Chun, VP of R&D at Laboratory Corporation of America. The audience was also given a vote, though, and split from the official ruling, as Canadian Dx firm Vital Biosciences received 37 percent of the audience vote, mass spectrometry outfit MS Pen Technologies won 35 percent of the vote, and Pattern nabbed 28 percent of the vote.
Vital is developing a microfluidics-based benchtop clinical analyzer capable of running commonly ordered hematology, clinical chemistry, and immunoassay-based tests. According to the company, the system can work with blood sample volumes as small as 600 uL and will return results in around 20 minutes.
Vital aims to place its instruments in facilities like doctors' offices and urgent care centers, improving access to laboratory testing and, according to Mounir Koussa, Vital's cofounder and VP of R&D, allowing "patients to get to diagnosis, treatment, and immediate intervention all within a single visit."
Longer term, it is also working on a home version of the device that Koussa said would be aimed at improving remote patient monitoring and care.
The company plans to launch with a test menu consisting of a complete blood count, a comprehensive metabolic panel, a lipid panel, A1c, gamma-glutamyl transferase, and 10 common immunoassays. Koussa said this panel will be focused on Medicare patients. He added that the company planned to target value-based care and urgent care settings, in particular.
"We find more and more that bringing diagnostics closer to the patient sits at the center of two massive trends in healthcare, the shift into value-based care and the shift into consumer-driven care," he said.
To date, Vital has raised $48 million from investors including Lachy Groom, Northpond Ventures, Sam Altman, Marc Benioff, Labcorp, Inovia Capital, and Route 66 Ventures.
MS Pen Technologies, the last of the three finalists, is developing a mass spectrometry-based tool for real-time analysis of clinical samples as well a variety of research purposes. Formerly called Genio Technologies, the Houston-based company plans to launch a research-use version of the device called the UNISS in Q1 2024.
It is also developing a clinical version of the device called the ULTISS. Livia Eberlin, CSO of MS Pen Technologies and one of the lead developers of the platform, said the company plans to begin the FDA pre-submission process for the ULTISS next year.
Both devices use ambient ionization mass spectrometry, a method in which ions are generated directly from a target sample and injected directly into the mass spec, allowing for rapid analysis. The mass spec pen instruments use drops of water applied with a pen-like probe to extract lipids, metabolites, and other molecules from samples, generating molecular profiles that can be used to, for instance, distinguish between cancerous and healthy tissue or identify microorganisms at an infection site.
To date, MS Pen has largely focused on developing its technology for use in identifying cancer margins during surgery, the idea being that the device could provide a real-time alternative to traditional pathology. Eberlin said that the company is pursuing lung cancer as its first indication and plans to position it as "an adjunctive surgical tool for the identification of lung cancer tissue" both in vivo during surgery and in ex vivo analysis.
Eberlin said the company also plans to implement the device in clinical microbiology, an area where it has published data in the past, as well as toxicology.