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Our Technology

cf-DNA Fragmentomics: A Superior Approach To Measuring Tumor Burden

Our goal is to deliver actionable information to the physician about their patient's cancer. To deliver on this goal, test results that are delivered to the physician must be both accurate and timely. For therapy monitoring, this means a test result must be delivered between two and three weeks after the therapy is administered. This presents three practical challenges to our scientists: 1) tumors typically undergo very small changes in the two to three-week time frame we require in order to deliver an actionable test result to physicians; 2) our lab must be able to deliver a result back to the physician within 48 hours of specimen collection for the information to be clinically actionable and relevant; and 3) the test must be cost effective.

To meet these goals, we have developed a novel, patented technology that is both accurate and timely. Our technology uses qPCR and exploits the facts that cancer cells, when they die, shed their DNA in fragment lengths that are shorter than non-cancer cells. We have developed a a technology that targets short fragments of DNA that come from Retrotransposable element (REs), a non-coding region of the genome. There are 1,800 copies of the target REs we target in every cell. This makes our technology extremely accurate and, critically, reproducible.

The approach other diagnostic companies have chosen is to identify ctDNA by attempting to matching tumor DNA from a patient with one of the hundreds of known somatic cancer mutations. The approach is slow and expensive. And not all tumors have a mutation that can be identified in their panels.

Additional Applications

In addition to Alibrex, Cadex Genomics has additional assays planned for development with the following intended uses:

  • Alibrex for early stage cancer patients receiving neo-adjuvant treatment.
  • Radiation-free cancer recurrence monitoring.
  • Confirm the clinical stage in early-stage cancer.
  • Active surveillance monitoring for prostate cancer.

Cadex Genomics intends to be a major participant on the front lines of the war on cancer. To that end, we are working diligently to provide effective, yet affordable, tests that can be made available to cancer patients globally.

For further reference

  • Sudhir Sinha, Multiplexed real-time polymerase chain reaction cell-free DNA assay as a potential method to monitor stage IV colorectal cancer, article in press DOI: 10.1016/j.surg.2019.06.004.
  • Scott Kopetz, MD Anderson Cancer Center ASCO 2018 Poster (8 additional patients added post ASCO presentation).
  • Corcoran et al, Application of Cell-Free DNA Analysis to Cancer Treatment. N Engl J Med 2018;379:1754-65.
  • Morten Lapin et al, Fragment size and level of cell-free DNA provide prognostic information in patients with advanced pancreatic cancer. Lapin et al. J Transl Med (2018) 16:300.
  • Yu et al, Recent Advances in Clinical Applications of Circulating Cell-free DNA Integrity. Lab Medicine Winter 2014 | Volume 45, Number 1.
  • Callinan & Batzer, Retrotransposable Elements and Human Disease, Genome and Disease. Genome Dyn. Basel, Karger, 2006, vol 1, pp 104-115.
  • Forschner et al, Tumor mutation burden and circulating tumor DNA in combined CTLA-
  • Mouliere et al, Enhanced detection of circulating tumor DNA by fragment size analysis. Sci Transl Med. 2018 Nov 7;10(466).
  • Tie et al, Circulating tumor DNA as an early marker of therapeutic response in patients with metastatic colorectal cancer. Annals of Oncology 26: 1715-1722, 2015.
  • Batzer et al, Alu Repeats and Human Genomic Diversity. Nature Reviews Genetics, volume 3, pages 370-379 (2002).