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Lab-Quality Quantitative Results— In Just 2–5 Minutes

We enable gastroenterologists to make treatment decisions in less than 5 minutes—without compromising lab-quality results.

ProciseDx Cartridge

Why Choose ProciseDx?

Our point-of-care platform combines speed, simplicity, and accuracy to transform patient care in real time.

Easy

A finger-prick sample and minimal staff training is all you need. No complex lab infrastructure required.

Immediate

Total turnaround time is only 2 to 5 minutes. Every minute matters during a patient appointment.

Accurate

Central-lab quality, sensitivity, and specificity. Healthcare professionals don’t have to sacrifice accuracy for speed.

ProciseDx Lab

About ProciseDx

We are revolutionizing point-of-care diagnostics by enabling gastroenterologists to make real-time, data-driven treatment decisions. With the rise of TNFα therapies for Inflammatory Bowel Disease (IBD), consistent monitoring is essential to optimize patient outcomes.

Our proprietary drug monitoring assays deliver lab-quality results from a fingerprick whole blood sample in under 5 minutes—empowering clinicians to adjust therapy during the patient visit.

“With ProciseDx, we will be able to measure levels of infliximab and adalimumab in five minutes from fingerstick blood. This information during the patient visit will be incorporated into our immediate treatment decisions.”

Our Technology

Leveraging time-resolved Förster Resonance Energy Transfer (tr-FRET) detection and patented chemistry, ProciseDx delivers rapid, quantitative immunoassays with unmatched precision.

How It Works

  1. Finger-Prick Sample: Collect a small volume of whole blood with minimal discomfort.
  2. Insert Cartridge: Load sample into the single-use assay cartridge.
  3. Run Test: Insert into the ProciseDx reader—results in 2–5 minutes.
  4. Immediate Decision: View quantitative drug levels and adjust therapy on the spot.

Instrument and CRP now FDA Cleared. Other assays not yet available for sale in the United States.

Assay Menu

Our growing portfolio of quantitative immunoassays supports precision medicine in gastroenterology and beyond.

Infliximab Quantitative

Monitor therapeutic levels of infliximab in IBD patients.

  • • Sample: Fingerprick whole blood
  • • Time to Result: <5 min
  • • FDA Cleared: Yes

Adalimumab Quantitative

Quantify adalimumab levels for personalized IBD therapy.

  • • Sample: Fingerprick whole blood
  • • Time to Result: <5 min
  • • FDA Cleared: Yes

CRP (C-Reactive Protein)

Inflammatory marker for monitoring disease activity.

  • • Sample: Whole blood or serum
  • • Time to Result: 3 min
  • • FDA Cleared: Yes

Vedolizumab Quantitative

Monitor gut-selective biologic therapy levels.

  • • Sample: Fingerprick whole blood
  • • Time to Result: <5 min
  • • FDA Cleared: In Development

Ustekinumab Quantitative

Support dosing decisions for IL-12/23 inhibitor therapy.

  • • Sample: Whole blood
  • • Time to Result: 4 min
  • • FDA Cleared: In Development

Therapeutic Drug Monitoring Panel

Comprehensive panel for multiple biologics.

  • • Sample: Fingerprick whole blood
  • • Time to Result: <6 min
  • • FDA Cleared: In Development

Anti-Drug Antibodies (ADA)

Detect immunogenicity to biologic therapies.

  • • Sample: Serum or plasma
  • • Time to Result: 5 min
  • • FDA Cleared: In Development

Fecal Calprotectin (Future)

Non-invasive marker of intestinal inflammation.

  • • Sample: Stool
  • • Time to Result: 6 min
  • • FDA Cleared: Research Phase
2-5
Minutes to Result
1
Finger-Prick Sample
FDA
Cleared Instrument & CRP

Latest News

ProciseDx Announces FDA Clearance for CRP Assay

September 2023 – The CRP immunoassay is now FDA cleared, expanding the platform’s capabilities in inflammation monitoring.

Clinical Study Validates 5-Minute Infliximab Monitoring

August 2023 – Data confirms high correlation with central lab methods, supporting real-time decision-making in IBD care.

Stay Informed

To learn more about ProciseDx or speak with our team, please visit our official website.

ProciseDx

9449 Carroll Park Drive, San Diego, CA 92121, United States

Email: [email protected]

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