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ProciseDx Enters Markets for Inflammation, Medication Monitoring With Five-Minute POC Instrument


NEW YORK ─ ProciseDx is entering the diagnostic testing market for inflammatory conditions with a point-of-care immunoassay platform that uses a technology called time-resolved measurement of fluorescence with fluorescence resonance energy transfer, or TR-FRET, which enables quantitative results using fingerstick blood or stool samples.

The firm last week announced a $13 million convertible note financing to support the US regulatory approval and commercialization of its immunoassay platform, enable it to grow its test menu for gastroenterologists, and help it lay a foundation for international expansion, Peter Westlake, the firm's president and CFO, said in an interview.

The point-of-care immunoassay platform — a desktop system suitable for near-patient testing — provides a test turnaround time of between two and five minutes, according to Westlake.

"FRET technology has been around central labs for a while, and even in the lab one of its main advantages is speed," Westlake said. "We've taken that central lab technology, miniaturized its application, and added the time-resolved piece."

In a central lab and at the point of care, users can deploy the technology to run assays normally run by ELISA platforms, he said, adding, "When our instrument reads fluorescence, it waits a couple of milliseconds until the background fluorescence you get from red blood cells has died down."

That enables the use of whole blood as a sample, which is often a requirement for testing at the point of care, Westlake said, adding that overall, its technology also enables testing with stool, urine, or saliva samples.

The test system consists of a capsule with lyophilized reagents to which a buffer and the sample are added. The capsule is inverted and inserted into a battery-powered instrument that can fit into a backpack, which is designed to have few moving parts for reliability, Westlake said.

"We combine that with the instrument's speed, and what we've done is to make it more practical such as use lyophilized reagents that can be stored at room temperature for two years," Westlake said, noting that all are important features for an instrument that can be used near patients in a physician's office or a crowded hospital.

In 2019, ProciseDx was part of Prometheus Laboratories, then a subsidiary of Nestlé Health Science. Nestlé had acquired Prometheus in May 2011 but sold it in June of that year to Precision IBD. Nestlé is the majority owner of ProciseDx, while French diagnostics company Biosynex, one of its investors, owns 37 percent.

After spinning off from Prometheus in 2019, ProciseDx locked down the design of the TR-FRET instrument, which had been under development for the previous three years, and announced plans to launch assays for use in diagnosing and treatment monitoring of inflammatory conditions, such as inflammatory bowel disease; autoimmune conditions, such as celiac disease; and metabolic syndromes, such as diabetes and pre-diabetes.

The company recently launched four gastroenterology assays for European markets on the back of CE marking. It obtained its first CE mark, which was specifically for its point-of-care instrument, in September 2019, and that laid a foundation for the development of a portfolio of rapid tests for physician offices, retail clinics, and urgent care settings, according to Westlake.

The firm obtained the CE mark for its Procise CRP, or C-reactive protein, assay in January 2020 and announced CE marking for separate tests to measure levels of infliximab and adalimumab on its ProciseDx immunoassay system in September last year.

The Procise IFX test, for infliximab, and Procise ADL, for adalimumab, provide information to physicians doing therapeutic drug monitoring to improve treatment for patients taking those biologics. Infliximab (Janssen Biotech's Remicade) and adalimumab (AbbVie's Humira) are used to treat inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Both are monoclonal antibodies that work by blocking specific immune responses.

"These drugs are broadly used and very effective in a number of inflammatory conditions," Westlake said. "Different patients need to be dosed with different amounts to achieve the same impact, and our tests help physicians with this precision dosing exercise."

With ProciseDx's point-of-care instrument and tests, physicians can obtain a rapid turnaround instead of having to wait up to 10 days to get results from a lab test before adjusting medication doses, according to Westlake.

In February this year, ProciseDx also received CE marking for its Procise FCP, or fecal calprotectin, point-of-care test for inflammatory bowel disease.

Procise FCP can be used to provide more specific information about inflammation than CRP, Westlake said. CRP can pick up on many causes of inflammation, but fecal calprotectin is a more specific marker of inflammation related to the conditions being treated by Remicade and Humira, he said.

The test is designed to assist in the diagnosis of Crohn's disease, ulcerative colitis, and other digestive conditions. Stool is collected by patients at home into a device that mixes the sample with a liquid buffer for testing and avoids having to refrigerate the sample.

The firm has signed on its first customers to use its tests and is growing its customer base, Westlake said, and it has shipped more than 100 instruments to the Europe, Middle East, and Africa regions. Revenues for 2021 are expected to be between $2 million and $3 million.

The firm has also submitted a 510(k) application to the US Food and Drug Administration for clearance of its instrument and C-reactive protein assay. Further US submissions for additional gastrointestinal assays are expected in 2021.

The agency has stated that during the COVID-19 pandemic, non-COVID-19 tests have been deprioritized in the regulatory review process. "However, we are now under active review and hoping for a decision in the near future that would be a significant step toward making the test and platform available in the US," Westlake said.

Further, the company has established distribution relationships in more than 15 countries in EMEA and expects to continue its market expansion this year. Last September, it announced distribution agreements for its platform and assays with BHR Pharmaceuticals in the United Kingdom and DID Diagnostic International Distribution in Italy.

Procise CRP, Procise IFX, and Procise ADL are three separate tests that are often run together in a doctor's office during one visit, Westlake said. In a typical visit, a patient has a specific drug level that needs to be measured, and the doctor needs to know the patient's inflammation levels. Run together, the three tests enable the doctor to triangulate results immediately and adjust the dose if needed, Westlake said, adding, "It's no coincidence that we picked these tests for our menu."

European studies involving the Procise fingerstick tests have shown that they provided similar performance to central laboratory tests, Westlake said.

A study published in May in the Journal of Crohn's and Colitis found that its platform provided a rapid, user friendly, and reliable measurement of CRP, IFX, and ADL concentrations within minutes. "The capillary CRP was slightly lower than the venous serum CRP, which was consistently observed and considered clinically irrelevant in this cohort," the researchers said.

A separate study also published in the Journal of Crohn's and Colitis reported that the ProciseDx point-of-care test "has similar accuracy but was more rapid and easy to be performed in providing the results of [therapeutic drug monitoring] in outpatients taking ADL. This could lead to a more rapid and effective optimization of the biological drug, thus avoiding treatment failure."

In Europe, most of the company's sales have been to major hospitals where most patients receive Remicade and Humira treatments. In the US, the firm intends to target hospitals and standalone gastroenterology clinics where patients also receive such treatments. Rather than approach customers through distributors, which is its sales approach in Europe, the San Diego-based firm intends to approach US customers directly with an internal sales staff.

The firm is offering the instrument for sale or through a reagent rental agreement. Though the firm is not disclosing specific pricing, the instrument "costs in the thousands, rather than tens of thousands, of dollars," Westlake said, adding that patients will use current CPT codes for test reimbursement.

Because its TR-FRET technology is broadly applicable, ProciseDx is "looking into additional test applications," Westlake said. "We're not going public about the types of tests in the near-term pipeline until we are sure we have the required technical performance."