Eximius Diagnostics is developing extracellular vesicle (EV) based liquid biopsy tests for cancer diagnosis and treatment monitoring.

Market:

There are ~4.5 million patients in the US at high risk for Hepatocellular Carcinoma (HCC), and for whom the American Association for the Study of Liver Diseases (AASLD) recommends biannual liver ultrasound screenings. Noninvasive HCC laboratory tests currently represent a $1.5 billion market, despite a current compliance rate of only 25% among these patients. More effective and convenient HCC surveillance solutions could improve patient compliance, leading to a projected market of $4.0B by 2032.

Technology:

Eximius Liver Cancer Test is an in vitro diagnostic (IVD) test that detects hepatocellular carcinoma (HCC) using human plasma samples collected from at-risk liver cirrhotic patients and has received FDA Breakthrough Device Designation. Eximius Liver Cancer Test uses qPCR technology to quantify HCC EVs, enabling early-stage (Stage 0-A) HCC detection. When used in conjunction with liver ultrasound, Eximius Liver Cancer Test is intended to aid in the detection of HCC.

Advantages:

  • Non-invasive, low-volume blood draw
  • Breakthrough device designation from FDA
  • Platform with multiple clinical utilities
  • Low-cost, broadly deployable qPCR assays
  • Improved sensitivity and specificity over ultrasound alone

Development Stage:

  • Clinical

Patents Issued:

  • “Covalent chemistry enables extracellular vesicle purification on nanosubstrates toward early detection of hepatocellular carcinoma” (2021), WO2021195549A1
  • “Extracellular vesicle protein assay for noninvasive diagnostics” (2023), WO2023196867

Select Publications:

Contact:

Website: Coming soon
Phone: (661) 714-1012
Email: smalleymatthewd@gmail.com, HRTseng@mednet.ucla.edu
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