NEW YORK – After receiving 510(k) clearance from the US Food and Drug Administration and CLIA waiver last month, CytoChip is gearing up to launch its handheld analyzer and complete blood count (CBC) test in the US.
The Irvine, California-based company was founded in 2016 by researchers from the California Institute of Technology to further develop microfluidic technology for point-of-care CBC testing, according to CytoChip CEO Wendian Shi. The technology originated from Shi's Ph.D. thesis and from a research project sponsored by the National Aeronautics and Space Administration to perform partial CBC tests in space, but the founders soon realized there was an opportunity to apply its technology in the medical field on Earth, as well.
The firm's CitoCBC test relies on a small portable analyzer and a single-use test cartridge that can be used with both venous and capillary blood samples, although the CLIA waiver only allows for use with venous blood right now. Once a drop of blood is placed on the test cartridge, it is moved into the cartridge automatically by capillary force and then sealed by the user and placed into the analyzer, where a result is returned in about eight minutes.
The CitoCBC test reports the CBC parameters of white blood cell count, red blood cell count, platelet count, hemoglobin concentration, hematocrit, and mean corpuscular volume, as well as five-part white blood cell differential counts and percentages for neutrophil, lymphocyte, monocyte, eosinophil, and basophil.
The cartridge is the "key technology" that enabled the company to miniaturize sample preparation for the test, Shi said. The core of the cartridge consists of a unique patented microfluidic design that allows for the advanced flow cytometry of a blood sample. The cartridge is able to meter out a certain volume of blood and store the reagent inside at room temperatures. The design also enables the combination of the blood and reagents into multiple different sample mixtures — one that can be used for white blood cell testing and one that can be used for red blood cell and platelet measurement.
The cartridge has a "very simple structure" to ensure that it is relatively easy and affordable to manufacture. It includes one piece of plastic that has been injection-molded and two pieces of plastic film.
The analyzer, meantime, was designed entirely around the cartridge, Shi said. The cartridge is "the heart of the device," so everything, such as the pneumatics used to drive the fluidic transfer, the optics to measure the signal, and the chemistry to label the cells, has been built around the framework of the cartridge, he noted.
It "not only has to deliver testing … [but] has to be manufacturable in a low-cost process," he added. Instead of focusing on the chemistry of the assay, the company emphasized the fluidics design and adapted the chemistry and optics to work with the fluidics it wanted, Shi said.
Although CBC testing is the first application, Shi said the analyzer could be used with bead-based assays that use microparticles to capture proteins or other molecules or with other kinds of immunoassays, such as those for measuring thyroid function.
Jane Emerson, a professor of clinical pathology at the University of Southern California who helped CytoChip with its validation work and serves as a medical adviser for the company, said that the test would be "extremely useful" in settings where the next step of care relies on CBC testing results, such as outpatient infusion centers or emergency departments.
She noted that the instrument is easy to use and reliable and that in her view, there are no further development steps that need to be taken.
While the cloud of Theranos hangs over any company attempting to develop and commercialize a point-of-care blood-testing device, Emerson said that CytoChip has been "extremely methodical and careful about every aspect of the equipment development and design" and, unlike Theranos, has conducted validation studies and received FDA approval. Theranos did receive FDA clearance for a fingerstick herpes simplex 1 test, but nonetheless was "100 percent sham," Emerson said, while CytoChip has an "actual point-of-care device that has been cleared."
Shi noted that the receipt of both FDA 510(k) clearance and CLIA waiver "proves the validation of the device."
A study published in November in the American Journal of Clinical Pathology that Emerson coauthored validated the analyzer against the Sysmex XN Automated Hematology System and found that CytoChip's accuracy, precision, and abnormal flagging were equivalent.
Now that the analyzer and CBC test have received FDA clearance and CLIA waiver, the company is looking to commercialize its products. CytoChip is currently in discussions with multiple unnamed national distributors that "dominate the physicians' office market" and could help place its products in the hands of clinicians, Shi said. There have also been discussions with strategic companies that are "well-known in the field for point-of-care testing" that may be interested in exclusively licensing the technology or investing in or acquiring the company, he added.
The company's priority is to "work with distributors to bring the device to customers, but we're also open to those … strategic opportunities," Shi said. CytoChip is also looking for distribution partners in Europe and is in the process of getting regulatory clearance there.
Beyond physicians' offices, the device could also be used in urgent care centers that are looking to bring laboratory testing in-house or retail clinics that don't have large enough testing volumes to maintain moderate-complexity testing expertise.
Shi noted that cost is particularly important to the company, as the US Centers for Medicare and Medicaid Services reimbursement rate for CBC testing is "pretty low" and the company wants to allow healthcare providers to offer testing without punishing them financially. CMS currently reimburses CBC testing at $7.77 per test. The firm is attempting to lower the cartridge's cost to below $7 per cartridge, but Shi noted that the company doesn't yet have the high volumes that will help it lower the manufacturing costs.
The analyzer is a separate, one-time purchase that will likely cost a little more than $10,000 per unit.
CytoChip has raised about $12 million from investors in Asia, including strategic and boutique investors, and is planning to start fundraising in the US this year, Shi said.