ProciseDx receives FDA de novo authorization for therapeutic drug monitoring tests

LabPulse.com staff writers
Oct 5, 2023
Fda Button Social

ProciseDx has received U.S. Food and Drug Administration (FDA) de novo marketing authorization for its point-of-care (POC) tests for monitoring levels of infliximab and adalimumab in patients being treated for inflammatory bowel diseases ulcerative colitis and Crohn’s disease.

ProciseDx said in a statement that it intends to commercialize the two tests -- Procise ADL to quantify adalimumab concentrations and Procise IFX to quantify infliximab concentrations -- during the current quarter. The firm is collaborating with Chembio Diagnostics to launch the tests. ProciseDx and Chembio Diagnostics are subsidiaries of POC diagnostics firm Biosynex, which acquired both companies in the past year.

The two tests have previously received the CE Mark in the European Union. ProciseDx's assay platform measures drug concentrations in serum using time-resolved measurement of fluorescence with fluorescence resonance energy transfer.

"Currently, results for drug concentrations for infliximab and adalimumab take days and require shipment to expensive third-party laboratories. The ProciseDx platform will change that with a simple workflow producing a reliable quantitative measurement in five minutes or less," said ProciseDx CEO Larry Mimms in a statement.

Latest in FDA Clearance
Fda Button Social
Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
April 26, 2024
Fda Button Social
Prenosis gets FDA authorization for AI-based sepsis diagnostic tool
April 8, 2024
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
April 5, 2024
Fda Sign Dc Social
BioMĂ©rieux gets FDA 510(k) clearance, CLIA waiver approval for panel
March 27, 2024
Related Stories
Hands Shaking Deal Social
Mergers & Acquisitions
French point-of-care testing firm Biosynex to acquire Chembio Diagnostics for $17.2M
2019 05 18 00 32 7363 Blood Cells 200
CE mark
ProciseDx wins CE Mark for point-of-care tests
2020 05 12 23 02 2430 Lab Crp Test 400
Diagnostic Technologies
ProciseDx moves forward with CRP test
Visit our Molecular Diagnostics Community
Sponsor Content
Visit our Molecular Diagnostics Community
More in FDA Clearance
Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
By Matt Limb
Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
April 26, 2024
Fda Button Social
Prenosis gets FDA authorization for AI-based sepsis diagnostic tool
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization to artificial intelligence (AI) healthcare firm Prenosis' AI-based ImmunoScore sepsis risk-assessment software.
April 8, 2024
Fda Button Social
Basilea gets FDA approval for antibiotic
By LabPulse.com staff writers
Swiss pharmaceutical manufacturer Basilea has received U.S. Food and Drug Administration (FDA) approval for its antibiotic Zevtera (ceftobiprole) for three different types of infections.
April 4, 2024
Fda Sign Dc Social
BioMĂ©rieux gets FDA 510(k) clearance, CLIA waiver approval for panel
By LabPulse.com staff writers
BioMĂ©rieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.
March 27, 2024
Fda Sign Dc Social
Boston Scientific gets FDA approval for drug-coated balloon catheter
By LabPulse.com staff writers
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent drug-coated balloon, a paclitaxel-coated balloon catheter sized to fit within blocked or constricted coronary arteries to treat coronary in-stent restenosis.
March 4, 2024
Artery Heart 3 D Social
FDA grants accelerated approval to Iovance’s melanoma cell therapy
By LabPulse.com staff writers
The FDA granted accelerated approval to Iovance Biotherapeutics’ T-cell therapy treatment for unresectable or metastatic melanoma.
February 21, 2024
Melanoma Social
T2 Biosystems gets FDA nod to expand bacteria panel
By LabPulse.com staff writers
T2 Biosystems announced it received 510(k) clearance to add A. baumannii to its T2Bacteria Panel.
February 12, 2024
Fda Button Social
Why many high-risk IVDs are being reclassified
By LabPulse.com staff writers
The FDA announced that its Center for Devices and Radiological Health (CDRH) will reclassify most in vitro diagnostics (IVDs) that are in the high-risk category to moderate risk to allow their manufacturers an easier path to FDA clearance.
February 1, 2024
Fda Sign Dc Social
Imvaria gets FDA marketing authorization for Fibresolve
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Imvaria for the use of Fibresolve.
January 16, 2024
Lungs 3 D Research 400
FDA approves test for opioid use disorder risk assessment
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a test designed to determine if a patient is at risk of developing opioid use disorder (OUD).
December 21, 2023
Pills Bottle Social
FDA approves Abbott laboratory automation system
By LabPulse.com staff writers
Abbott’s new laboratory automation system has received U.S. Food and Drug Administration (FDA) approval, the company announced in a statement.
December 14, 2023
Fda Button Social
FDA clears BD’s new fingerstick blood collection device
By LabPulse.com staff writers
BD (Beckton, Dickinson and Company) received 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its new sample collection device system that pulls blood from a fingerstick to enable common blood tests without need for a phlebotomist.
December 7, 2023
Fda Sign Dc Social
Page 1 of 7
Next Page