Community-based clinical trial

Biological Dynamics launches ExoVita™ Pancreas and enrolls patients in ExoLuminate clinical trial

Retrieved on: 
Wednesday, February 8, 2023
Oncology, Health, Other Science, Clinical Trials, Research, Science, Biotechnology, Master of Science, Community-based clinical trial, Pancreas, CLIA, Biological Dynamics of Forest Fragments Project Area of Relevant Ecological Interest, Pancreatitis, LDT, Patient, RUO, Medical Affairs Bureau, Exosome, Biology, PDAC, CAP, Pharmaceutical industry, Medical imaging, MD

With this validation, samples from the ExoLuminate registry trial ( NCT05625529 ), a trial which has already begun actively enrolling patients with high-risk for PDAC to investigate the test’s clinical utility, will be tested by the company.

Key Points: 
  • With this validation, samples from the ExoLuminate registry trial ( NCT05625529 ), a trial which has already begun actively enrolling patients with high-risk for PDAC to investigate the test’s clinical utility, will be tested by the company.
  • “Our published, high sensitivity ExoVita Pancreas assay for early-stage pancreatic cancer is being further validated with prospective clinical samples from our ExoLuminate registry trial.
  • ExoVita Pancreas is a ‘Research Use Only’ (RUO) test produced from Biological Dynamics’ CAP/CLIA certified lab.
  • Any and all clinical decision-making remains with each study patient participant and their physician providers.

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Retrieved on: 
Friday, September 17, 2021
Biotechnology, General Health, FDA, Health, Pharmaceutical, Food, H. Lee Moffitt Cancer Center & Research Institute, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Community-based clinical trial, FDA, Cancer, Patient, Exelixis, EXEL, Adult, Prescription Drug User Fee Act, Thyroid cancer, Breakthrough therapy, Death, Community, Risk, HIV disease progression rates, VEGFR, Priority review, PDUFA, Jefferson Torresdale Hospital, DTC, Thomas Jefferson University, Nasdaq, Time, Pharmaceutical industry, COSMIC-311, DTC, CABOMETYX, COSMIC-311, DTC, CABOMETYX

The FDA approval of CABOMETYX is an important advancement for these patients who are badly in need of new treatment options.

Key Points: 
  • The FDA approval of CABOMETYX is an important advancement for these patients who are badly in need of new treatment options.
  • Dose reductions were required in 56% of patients treated with CABOMETYX, and 22% of patients required a second dose reduction.
  • We are excited about the latest approval of CABOMETYX, which will offer hope for patients with this type of thyroid cancer.
  • Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer.

TrialSpark announces collaboration with Limbix on conducting an end-to-end clinical trial on Limbix's digital therapeutic for adolescent depression

Retrieved on: 
Tuesday, October 22, 2019
Clinical research, Health, Medical research, Clinical trial, Community-based clinical trial

"Working with TrialSpark to conduct a rigorous, community-based clinical trial will allow us to generate robust evidence that prescription digital therapeutics like Limbix Spark can be used for treatment."

Key Points: 
  • "Working with TrialSpark to conduct a rigorous, community-based clinical trial will allow us to generate robust evidence that prescription digital therapeutics like Limbix Spark can be used for treatment."
  • TrialSpark executes clinical trials by partnering with doctors to create clinical trial sites within their existing practices and providing them with equipment, software and personnel support.
  • TrialSpark has scaled a network of trial sites by partnering with doctors to create clinical trial sites within their existing practices.
  • Without variability in operations at the trial site level, TrialSpark cuts out the manual, time intensive and costly tasks that delay clinical trial timelines.