NEW YORK ─ Cellia Science is developing an analyzer that leverages deep-ultraviolet cell analysis and machine learning with the goal of enabling faster hematology testing for oncology patients at the point of care.
The Fayetteville, Arkansas-based startup, formed last month by healthcare investor VIC Technology Venture Development, is developing a desktop analyzer that uses a disposable cartridge to complete a five-part, white blood cell differential analysis and platelet count within five minutes.
Such a system has the potential to streamline hematology testing workflows and reduce the time to results compared to lab testing, CEO Kelly Mabry said in an interview.
"We're essentially creating a quantitative biomolecular map from a drop of blood," Mabry said.
If the firm obtains regulatory clearances and approvals, enabling it to launch the analyzer, the device would compete with lab testing in applications where fast results are most needed, including for oncology patients who need to know whether they should receive a next dose of chemotherapy, get a blood transfusion, or immediately be hospitalized, Mabry said.
Because the instrument can operate using a few microliters of blood, it may also be ideal for the testing of sick infants who can't obtain traditional lab testing because of the health risk associated with providing too much blood, she said.
Further, Cellia Science may eventually market the analyzer in low-income countries where patients require hematology testing but the laboratory infrastructure to run such tests doesn't exist, Mabry added.
Lab-based hematology tests are routinely used to detect blood disorders, including blood-clotting disorders, cancers, anemia, and infections. The tests are typically run on high-throughput instruments that use impedance measurements, light scattering, or fluorescent cytometry to obtain results. When samples are flagged for follow-up, their cells are often evaluated on a glass slide using staining and microscopy.
Such testing requires expensive instruments that need to be calibrated and maintained, reagents, and operation by highly trained personnel, and the lab-based workflow may mean patients who are very sick have to wait most of the day for test results, Mabry noted.
The new analyzer can provide rapid results by eliminating the requirement for staining and reagents while leveraging "an inherent property of cellular biomolecules, which is their adoption of specific wavelengths in ultraviolet light," Mabry said. "The technology enables us to simplify the instrument to a great degree and was a big driving force in our decision to move forward with this company."
The technology underlying the analyzer is based on research from the Georgia Institute of Technology, which developed an ultraviolet microscopy system that could be adapted for point-of-care use and licensed it to Cellia Science.
The analyzer combines deep-ultraviolet cell analysis with deep learning to identify and classify cell images. To operate the platform, a sample is placed on a disposable cartridge that converts a drop of blood into a monolayer. The cartridge is then plugged into the instrument for analysis. The use of low wavelength light and the direct detection of biomolecules enables better resolution than the traditional method of staining with Giemsa or similar dyes, the firm said. The analysis leads to a five-part, white blood cell differential analysis and platelet count that physicians can use for diagnosis of chemotherapy patients that are at risk of neutropenia or thrombocytopenia, among other conditions.
By eliminating the need for reagents and staining, the instrument and test would remove "a lot of the variability that might be introduced" during traditional blood smear analysis, Mabry said.
In a June 2020 study that described the hematology analyzer, which was published in the Proceedings of the National Academy of Sciences, Cellia Sciences' CSO Paco Robles and his colleagues noted that the technology's "fast, reliable, quantitative, and simple blood cell analysis in a low-cost configuration … can simplify and improve current clinical hematological analysis."
Mabry said that after running clinical trials to validate the point-of-care analyzer, Cellia Science will seek US Food and Drug Administration regulatory clearance and later seek regulatory approval to market the analyzer in Europe under the new In Vitro Diagnostic Regulation. However, it is not releasing timelines yet to initiate the clinical trials or apply to regulators.
The firm plans to eventually outsource the manufacturing of the analyzer and cartridge, and it expects to first market the product to oncologists in hospitals and clinics, especially to those that require rapid hematology testing for chemotherapy patients that are at risk of neutropenia, a low neutrophil count, and thrombocytopenia, a low platelet count, Mabry said.
Because the technology may be extended for use in other blood cell analysis applications, the company is planning a step-by-step strategy for adoption. When doctors observe the clinical utility of the analyzer in their oncology clinics, "our thought is that will help us expand its use to additional sites such as primary-care offices, pharmacies, and other types of convenient-care clinics," Mabry said.
That would enable more convenient testing for patients who are currently traveling hours to get to clinics for testing, she added. The firm believes that the analyzer may eventually be used in the home by patients as instrument costs are reduced.
With seed funding from the VIC Investor Network, the investment arm of VIC Technology Venture Development, the developers are currently optimizing the instrument and cartridge for manufacturing and ease of use by people without training, Mabry said, adding that the developers are aiming for a system that could be run by a medical assistant in the clinic or pharmacy technician.
According to VIC Investor Network, blood cell differentials for patients at risk of neutropenia or thrombocytopenia involves about 20 million tests annually in the US and represents a total addressable market of about $320 million.
If it reaches the market, Cellia Science can expect competition from firms that provide point-of-care tests for routine hematology screening for many conditions. These include Ängelholm, Sweden-based HemoCue, which obtained 510(k) clearance from the FDA for its HemoCue Hb 801 System in 2019, and Yokneam Ilit, Israel-based PixCell Medical, which offers HemoScreen, an FDA-cleared five-part differential complete blood count analyzer for point-of-care use.
Mabry noted that the Cellia Science point-of-care analyzer is too early in development to establish pricing, but the instrument price is expected to be an order of magnitude less than that of laboratory analyzers.
"Adoption of our instrument will represent a significant shift from the current standard of care," she said. "We therefore plan to establish an internal sales and marketing team with a large emphasis on education to help doctors transition to point-of-care testing. … As there could be valuable synergies in working with external distributors, that is an additional channel we will pursue."