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FDA Approval Opens U.S. Market for ProciseDX

BIOTECH: Drug Monitoring Device Already Being Adopted in Europe

ProciseDX Inc.’s gastroenterology and therapeutic drug monitoring testing platform is poised to enter the U.S. market.

In November, the company announced FDA approval of its ProciseDx instrument and C reactive protein (CRP) test, which can measure CRP levels in patient serum in a matter of minutes. The tests are used by doctors to determine and diagnose inflammatory diseases.

The CRP test is the first ProciseDX test to gain FDA clearance, allowing the company to soon sell its instrument in the U.S. ProciseDX instruments and a menu of tests are already approved in Europe. ProciseDx has obtained CE Marks for four of the company’s gastroenterology (GI) tests  and 80 instruments are installed or currently working towards implementation across Europe.

Peter Westlake
CEO
ProciseDX

“In Europe, the diagnostics market tends to be more open and less tightly regulated,” said ProciseDX CEO Peter Westlake, adding that even before the European launch of ProciseDX it was possible for hospitals or clinics to get therapeutic drug monitoring (TDM) test kits to run themselves, although at much higher cost and longer wait time than the ProciseDX solution offers.

“In the U.S., it’s not possible for them to do that at all right now,” Westlake said. “So we’re doing a leapfrog right to the most convenient solution with point of care. We expect when we launch in the U.S. this will be a nice solution for hospitals and GI practices.”

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Westlake said that the CRP test will be available in 2023, and that ProciseDX expects FDA will clear additional tests next year as well. The company has already submitted De Novo applications to the FDA for two TDM tests – Procise IFX which measures infliximab (Remicade and biosimilars) and Procise ADL measures adalimumab (Humira and biosimilars).

Versatile Solution, Better Outcomes

ProciseDX launched its platform of tests for GI diseases and treatments in Europe in 2020, just before the COVID pandemic. “Launching a non-COVID diagnostic in Europe during a pandemic was a challenge. But now we are seeing some momentum,” Westlake said, adding that he expects the U.S. market to adopt the platform even faster because GI testing is “harder to get a hold of” here.

Although the ProciseDX platform was made to be versatile and be able to be used for a variety of medical conditions, the company started in gastroenterology because it’s an area where there are not a lot of point of care solutions available.

“For a lot of those conditions, it takes patients a long time to get diagnosed because they have to cycle through a lot of doctor appointments, and that process means it is slow to diagnose these conditions – then when you’re managing them, that process is slow as well,” Westlake said, adding that the ProciseDX platform instrument provides doctors operational ease and cost-effectiveness.

Larry Mimms
President & Chief Scientific Officer
ProciseDX

“Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or days,” said Larry Mimms, ProciseDX president and chief scientific officer. “The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in five minutes or less.”

In addition to providing lower costs, the ProciseDX drug monitoring platforms will also bring better patient outcomes.

“Getting the right drug level is really how you make that drug more effective,” Westlake said.

Beyond monitoring the treatment of GI disorders, Westlake said ProciseDX plans to apply its drug monitoring to other specialties later. The company is looking at rheumatology and oncology as possible areas to expand into.

“Putting a new instrument in a doctor’s office can’t be a one-trick pony, so our instrument must be able do more than one test,” he said.

Licensing Agreement

In conjunction with the FDA approval announcement, ProciseDX also announced an agreement with its partner and shareholder Biosynex S.A. to take responsibility of distributing and commercializing ProciseDX tests in all of Europe, the Middle East and Africa.

“That helps us here as we prepare for a U.S. launch. It helps us focus on all the U.S. preparations,” Westlake said.

Thierry Paper
Deputy CEO
Biosynex S.A.

The France-based Biosynex has been a ProciseDX partner and shareholder since the European launch of the platform in 2020. The new agreement expands and clarifies Biosynex’s role in Europe, the Middle East and Africa in supplying existing and future ProciseDx distributors for those regions. ProciseDx Inc. retains all rights and responsibilities for U.S., Canada, China and Japan.

“Biosynex has made point of care and therapeutic drug monitoring a strategic focus,” said Thierry Paper, deputy CEO of Biosynex S.A. “We have demonstrated our expertise in rapid testing through the COVID pandemic. We see many potential areas of expansion for the ProciseDx technology.”

ProciseDX

Founded: 2019
CEO: Peter Westlake
Headquarters: San Diego
Business: In vitro diagnostics company with a proprietary instrument platform and portfolio of point of care diagnostic tests.
Revenue: Just under $2 million (2021)
Employees: 25
Website: www.procisedx.com
Notable: The ProciseDX testing platform can give therapeutic drug monitoring results in under five minutes from just a simple blood sample.

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