Patents cover the entirety of the sub-$200 test and platform, which isolates rare circulating tumor cells (CTCs) from one tube of blood. CellMax Life enables early cancer detection and management with affordable, non-invasive blood tests.
CellMax Life, announced today that six U.S. patents had been granted for its biomimetic platform CMx, which detects circulating tumor cells (CTC). The patents cover the entire detection workflow.
It covers from the capture of very rare CTCs present at fewer than five cells per billion normal cells in early-stage cancer to the processes ensuring their intact release and identification using advanced imaging techniques, allowing CellMax Life to detect CTCs in up to 90% of samples. In addition to these six U.S. patents, there are also 16 global patents issued and several additional patents pending in its growing portfolio.
“In the past, finding CTCs was not possible in pre-cancer and early-stage cancer, as the cells numbered too few to identify in the bloodstream accurately,” said Shai Friedland, M.D., Chief of Gastroenterology & Hepatology, VA Palo Alto Health Care System from the Stanford University School of Medicine.
“The CellMax CMx platform’s ability to achieve high sensitivity for pre-cancerous colorectal lesions, while remaining cost-effective and convenient is notable. The CMx platform positions CellMax Life’s CTC test to potentially become a standard option for the 100 million Americans over the age of 45 who are eligible for colorectal cancer screening,” said Friedland.
The CellMax CMx platform has its origins in research conducted on biomimetic smart materials and interfaces by Professor Ying Chih Chang1 at Stanford University.
It captures CTCs in a process that involves passing two milliliters (ml) of blood through a microfluidic chip with a patented surface coating – a biomimetic structure that mimics the human cell surface membrane.
This membrane with custom monoclonal antibody promotes collaborative binding of CTCs, prevents non-CTC cells (such as blood cells) from sticking to the chip, and retains CTCs tightly during a gentle buffer purification.
Using an air-foam technique to release the viable CTCs to an Eppendorf tube safely, the eluted cells can be placed on a slide for staining and enumeration. A patented imaging technique is utilized to locate and identify the CTCs for analysis.
The eluted cells can also be cultured and used in the downstream molecular analysis, including next-generation sequencing of DNA and RNA and proteomics. Results of a clinical study utilizing CellMax’s CTC Platform, presented earlier this year at ASCO GI.
It also demonstrated that a blood-test developed using the CTC platform can detect colorectal cancer at an early stage, and even detect pre-cancer, with accuracy ranging from 84 to 88 percent by locating and identifying CTCs.