NEW YORK – Throughout 2022, point-of-care diagnostic firm Nanomix has made strides toward commercialization of its handheld analyzer and critical infection test panel, and the company has more deals on the way heading into 2023.
The Emeryville, California-based company has long been developing its electrochemical analyzer and S1 infection panel, and while the COVID-19 pandemic added an extra hurdle to its commercialization process, the instrument is on the verge of global availability, with plans for the firm to expand its reach even further in the coming months.
So far in 2022, Nanomix has announced an agreement with Biotron to distribute its eLab analyzer and S1 infection panel in Israel, as well as a Middle East distribution deal for the analyzer, the S1 panel, and future tests with IPS Genomix.
The firm also announced a collaboration with Mobility Health earlier this month to develop a point-of-care COVID-19 antibody test for use in mobile labs in the US. Under that deal, Mobility Health is developing the assay as a laboratory-developed test and will be pursuing Emergency Use Authorization for it from the US Food and Drug Administration. In May, Nanomix also received CE marking for a COVID-19 antigen test that returns results in 15 minutes.
Although COVID-19 testing is part of its plan, the firm's current focus is on the eLab analyzer and its S1 panel for critical infections, which simultaneously detects and measures procalcitonin, lactate, and C-reactive protein levels in 12 minutes. The immunoassay originally received CE marking for use with plasma in 2019 and got CE marking for use with whole blood in May.
The analyzer is able to perform enzymatic assays and immunoassays and uses an electrochemical sensor and microfluidics to achieve its quick turnaround time, CFO David Ludvigson said. He noted that many instruments are based on optical systems, which are difficult to use in a mobile environment because they rely on specific alignments and are vulnerable to environmental factors. The eLab analyzer, however, doesn't use an optical system, making it more portable, and it contains a pneumatic system that works with the cartridge's microfluidics to always keep the sample under control, allowing it to run in less optimal conditions — such as in a helicopter or ambulance, he said. The system also doesn't require calibration.
The S1 panel, meantime, can be applied to sepsis or other critical infections, such as pneumonia, Nanomix Chief Commercial Officer John Hardesky said. There is a "huge unmet need" for sepsis testing, Ludvigson added, and the company's test would allow doctors to determine sepsis "next to the patient, wherever that patient might be" in less time than traditional methods. CEO Thomas Schlumpberger noted that many patients acquire sepsis outside of a hospital setting, and the portability of the eLab analyzer means they could be diagnosed before arriving at an emergency department. "That's where you really can save a lot of time and make a preliminary diagnosis, so they know what to do" once a patient arrives at the hospital, he said.
Hardesky said that the initial strategy is to market the test to hospital intensive care units and emergency departments, where it will have "the largest and most profound impact," and then "cascade out into the community from there." The main use case for the test is improving the turnaround time for measuring its three biomarkers and helping clinicians make better care decisions, so hospitals are the "lowest hanging fruit" for commercialization, he said. The firm currently has multiple early adoption studies ongoing in emergency departments in the US, as well as a study integrating the analyzer and test with a mobile care team outside of the hospital. Preliminary data is expected before the end of the year.
However, Schlumpberger added that the company is exploring the potential to work with CLIA laboratories to create a laboratory-developed test based on the S1 panel to get it to patients earlier and a wider variety of community and near-patient settings while the test goes through the regulatory process in the US. Nanomix has prepared a 510(k) submission for the S1 test and analyzer for the US Food and Drug Administration that it will be filing imminently, Ludvigson said. The firm had plans to file the submission sooner, but the impact of the COVID-19 pandemic on the FDA's workload and customer appetites for non-COVID-19 products led the company to delay the submission.
Outside of the US and beyond the deals Nanomix has already announced, other commercialization efforts are underway. Ludvigson noted that the company is still very early in its revenue creation — although it has had some orders, those will total less than $1 million for the second half of 2022 — and that the emphasis has been on widening territory coverage. With that in mind, the firm is preparing to announce several distribution deals in Europe, Hardesky said, though he declined to provide details. Nanomix also has a strategic partner in Singapore to help launch its products there and in southeast Asia, and it is going through the regulatory processes in both Japan and South Korea, he added.
2023 is expected to be the company's first year of significant revenue, Ludvigson said, with expectations of revenues in the mid-single digit millions, although that guidance depends on when FDA clearance is received. Schlumpberger noted, however, that the guidance for 2023 was conservative and based on a model where there are single distributors for single territories. The company is discussing deals with larger distributors that could cover entire continents and would raise the revenue expectations significantly, he said.
While the executive team declined to confirm the price of the test cartridge, saying only that the pricing will be competitive in the US market, Ludvigson said that the analyzer itself costs between $6,000 and $7,000. The reimbursement process for the test will be "direct," he added, since the assay can be billed under existing CPT codes and new codes won't have to be established. There is also the option for a reagent rental program where users can rent the instrument and pay some extra on top of the individual test price until the machine is paid off, Schlumpberger said.
Even though the company's current focus is on sepsis and critical infections, Schlumpberger said that Nanomix is looking ahead to determine its next products. The firm is doing market studies to define its pipeline and will know its next tests in five to six weeks, he said. One option could be to expand the S1 panel to pediatric patients. Ludvigson also mentioned the potential to develop tests for other infectious diseases, stroke, cardiology, kidney disease, or traumatic brain injuries.
Any disease where a fast turnaround time and high sensitivity are needed could be "a good product for the Nanomix platform," Schlumpberger said.