NEW YORK – Startup Cubit Diagnostics aspires to satisfy the needs of busy clinicians with a 15-minute test system that can perform both molecular tests and immunoassays. With a recent bolus of federal funding, the Carlsbad, California-based company plans to enter clinical trials for a COVID/flu test and its multimodal system in the near future.
Point-of-care labs are challenging places to work, according to Kunal Sur, Cubit's CEO and cofounder. They tend to be busy, noisy, and chaotic, without a ton of benchtop space. Having a single, small diagnostics platform with one workflow for all tests could be particularly helpful, Sur said, but high performance and low cost are also essential.
To fit this bill, Cubit has been developing its small, low-cost instrument and consumables from the ground up, Sur said. Each unit can run both the firm's immunoassay and molecular cartridges, and they can be daisy-chained together to enable simultaneous runs of two different assay types.
For molecular testing, the system uses an ultrafast PCR approach combined with proprietary sample preparation and microfluidics, Sur said, to multiplex up to eight targets per test with only approximately nine minutes of thermal cycling. The PCR method has also been developed to be used with sample types of varying complexity, from nasal swabs to urine, blood, sputum, and vaginal fluids.
For immunoassays and PCR testing on the fully automated system, the total time to results is approximately 15 minutes, with two minutes of hands-on time, and each testing module can run either type of assay. Cubit's assay design also enables the cartridges to be stored at room temperature, while the system itself was built to integrate easily with laboratory information systems.
Having all test results at the same time could be a "game changer" for clinicians sleuthing the best way to care for patients, according to Sujal Mandavia, an emergency physician and chief medical officer at Carbon Health who serves as an adviser to Cubit.
"Medicine is detective work," Mandavia said. "There's a moment where I have all of your information in my mind, I'm plugging in these data points, and I can make a decision for you."
On the other hand, "if I get a result two days later, not in the moment where I'm actually thinking and synthesizing your care, the moment is lost," he said. This potentially leads to a decay in the quality of decision-making. Worse yet, getting pinged with test results related to patients who left the office the week before can actually distract clinicians from patients that day.
For certain medical conditions where clinical guidelines suggest multiple test modalities, for example sepsis or cardiac care, the benefits could be even greater, Mandavia said.
While Cubit checks all the technology boxes, cost is also crucial at the point of care.
In a poster the firm presented at a Biomedical Advanced Research and Development Authority (BARDA) symposium in November, Cubit claimed a cost of goods per cartridge of $5 for molecular tests and $2 for immunoassays, which the firm said could enable it to have competitive pricing in many healthcare segments. The instrument cost, meanwhile, is projected to be less than $1,000.
Formally established in 2020 and spun out from Arete Biosciences in 2023, Cubit was recently awarded $2.6 million from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) Tech program to complete development and begin clinical trials for the instrument and an assay to detect SARS-CoV-2, influenza A, and influenza B. The award followed a $1.9 million grant from RADx Tech in 2023 for platform development.
Sur met Cubit's two other cofounders, Chief Technology Officer Sujit Jangam and CSO Sam Pickerill, while in graduate school at Northwestern University. There, he coauthored a number of patents with David Kelso, bioengineer and cofounder of Minute Molecular, and subsequently held engineering roles at GenMark Diagnostics and Quidel.
Cubit recently completed an evaluation of its COVID molecular test at Emory University and is planning a second evaluation for the COVID/flu test soon.
The team aims to begin clinical trials of the system around the end of 2025.
In terms of menu, it is developing an STI test for chlamydia, gonorrhea, trichomoniasis and antimicrobial resistance, as well as a tuberculosis test and a test for high-risk screening of HIV, hepatitis C virus, and hepatitis B virus, according to the BARDA poster. The firm also plans to expand its test menu through partnerships to add more immunoassays, as well as strep, sepsis, and urinary tract infection testing.
Added value
In infectious disease testing, molecular assays tend to be very much about identifying pathogens causing infections, Sur said, while small molecule assays, like immunoassays, can answer questions about how sick the patient is from their infection.
Using both modalities at the same time can therefore give clinicians a richer set of data to guide decisions such as whether to admit the patient to the hospital or which medication to prescribe them. It can also be used for treatment monitoring, he said.
"It's definitely an unmet need," Sur said, which had not previously been addressed because of the technical challenges with microfluidic consumables and instrument design.
During the pandemic, the Cubit team made a conscious decision to eschew COVID testing applications. That said, the diagnostics boom during that period also brought new approaches to light, Sur noted.
Ben Druce, product manager at Cubit, also said that the firm's long-game approach and cumulative diagnostics experience may differentiate it from others in the space.
In rapid point-of-care diagnostics, a plethora of startups launched during the pandemic joined a space pioneered by firms like Danaher's Cepheid, Becton Dickinson, Roche, and Abbott.
Other multimodal diagnostics in development for the point of care include a system from Fluxergy and the SpinDx from the National Institute of Standards and Technology. Norway's SpinChip, a spinning disc-based system developer recently acquired by BioMérieux for approximately $140 million, has also previously said it is developing isothermal molecular capabilities to run on its immunoassay system.
In his role at Carbon Health, a San Francisco-based chain of primary and urgent care clinics, Mandavia said he has explored almost every imaginable diagnostic approach to enhance patient care and expand the business from a commercial and services standpoint.
He noted that his colleagues in the health system are especially enthused about the future potential for multimodal diagnostics. "When I tell them [about it], their minds are blown," he said.
From Mandavia's perspective, "we've been working with very crude implements" in the point-of-care space to date that haven't allowed clinicians to actually follow algorithms and guidelines as closely as they would like.
Although clinicians are much better now at incorporating evidence-based guidance into practice, "it has taken decades, and we're not there yet," Mandavia said.
"You can have a really great algorithm, but if it requires data that I can't get, it might as well not exist," he said.
With multimodal testing, this can change, or even improve, as the tech can enable entirely new versions of clinical algorithms and guidance, he added.
"With my operational hat on, the elegance or simplicity of having a single device to train people on, to have to maintain, to take up less space" is valuable, Mandavia said.
Still, the patient care piece is key. "I can now get answers that reflect the complexity of the patient that I'm seeing," he said.