Patents cover entirety of sub-$200 test and platform, which isolates rare circulating tumor cells (CTCs) from one tube of blood
CellMax Life, enabling early cancer detection and management with affordable, non-invasive blood tests, announced today that six U.S. patents have been granted for its biomimetic platform CMx, which detects circulating tumor cells (CTC). The patents cover the entire detection workflow, 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 by means of advanced imaging techniques, allowing CellMax Life to detect CTCs in up to 90 percent 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 accurately identify in the bloodstream,” 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.”
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 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 safely release the viable CTCs to an Eppendorf tube, 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 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, 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.
“Tumors shed CTCs into the bloodstream starting at the early stages of cancer, which cannot be detected by standard imaging techniques,” said Rui Mei, Ph.D., Chief Scientific Officer of CellMax Life. “Other CTC technologies pre-process the sample in order to remove vast unwanted blood cells. But at the same time, the process can also lose precious, rare CTCs. As such, other platforms are only used for advanced cancers when CTCs are present at significantly higher numbers in a blood sample. We are excited to have a solution to the problem of finding the proverbial needle in the haystack, detecting cancer in its earliest stages when it is still curable.”
CellMax Life’s CTC platform is recognized and accredited by the College of American Pathologists and published in 40 different publications and abstracts, including the American Society for Clinical Oncology (ASCO), the American Association for Cancer Research (AACR) and the American Urological Association (AUA). Recently it won the MedTech Breakthrough Award for Best New Technology in Cancer Management.
CellMax Life recently launched Zenith, a U.S. clinical study with Stanford Medicine, Johns Hopkins, the University of Southern California, and the U.S. Department of Veterans Affairs Palo Alto Health Care System to further test the accuracy of its CTC platform.