Healio Gastroenterology | May 6, 2020 A novel, blood-based assay improved the detection of advanced and non-advanced adenomas by analyzing cell-free DNA and circulating gastrointestinal epithelial cells, according to research from Digestive Disease Week.
Becker’s Hospital Review | May 04, 2020 CellMax Life released results from its U.S. study of the FirstSight blood test that revealed the test detected colorectal cancer with 100 percent sensitivity at 90 percent specificity.
BIOCENTURY | JAN 18, 2018
CellMax Life Inc. (Sunnyvale, Calif.) reported that its CellMax-CRC colorectal cancer screening test detected colorectal cancer with 84% sensitivity and 97.3% specificity. The single-site, Taiwanese trial enrolled 620 adults who were undergoing a routine colonoscopy or who had adenomatous polyps or early to late-stage colorectal cancer.
HealthNewsDigest | Jan 20, 2019
According to the American Society for Gastrointestinal Endoscopy, colorectal cancer (aka colon cancer) is the second leading cause of cancer-related deaths in the United States (when men and women are combined). It is the third leading cause of cancer-related deaths when men and women are considered separately (behind lung and prostate cancer in men, and behind lung and breast cancer in women). The disease causes more than 50,000 deaths annually in the US.
Sunnyvale, California-based CellMax Life said today that it has partnered with Taiwan-based Medigen Biotech as part of the firm’s cell therapy clinical trials. Medigen will integrate CellMax’s CMx circulating tumor cell (CTC) platform with its liquid biopsy panel to examine patient treatment selection and response.
As part of the open-label, multicenter, single arm clinical trial, the team plans to enroll patients with stage II and III colorectal cancer that has separately been surgically resected or in addition to being treated with chemotherapy.
The partners will start the Phase I trial later this year with patients who test positive on the CMx test to receive the natural killer cell therapy treatment. The firms have designed the trial to track patients’ cancer status multiple times during treatment, using the CMx blood test to determine treatment response.
CellMax’s blood test isolates and analyzes both CTCs and cell-free DNA from a sample of blood to detect six types of analytes, including four classes of genomic mutations, microsatellite instability, and CTCs.
“Colorectal cancer is the second deadliest cancer in the US with 150,000 new cases and $14 billion spent on treatment annually,” CellMax Cofounder and CEO Atul Sharan said in a statement. “Medigen’s vision to develop innovative cancer therapies especially for the earlier stages of cancer when it is most treatable, is very much aligned to CellMax Life’s mission not reduce mortality from colorectal cancer.”
Financial details of the agreement were not disclosed.
“Because we expect to recruit patients with early-stage cancer, test sensitivity was the key criteria for platform selection,” Medigen Chairman and CEO Stanley Chang said in a statement. “By combining the CMx assay with the CellMax ct-DNA liquid biopsy … we hope to have the most sensitive test for treatment selection and monitoring response.”
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.
1Professor & Research Fellow, Genomics Research Center, Academia Sinica, Taiwan. Adjunct Professor Stanford University.
About CellMax Life
CellMax Life’s mission is to transform how cancer is detected and managed with globally affordable non-invasive tests for early cancer detection and monitoring. CellMax Life’s unique expertise in circulating tumor cells (CTC) and next generation sequencing (NGS) of DNA, as well as circulating tumor DNA (ctDNA) has enabled it to offer highly effective precision medicine solutions for healthy people, as well as patients diagnosed with cancer.
CellMax Life’s tests include CellMax-DNA Hereditary Cancer Risk Test, CellMax-CRC Colorectal Cancer Screening Test, CellMax-Prostate Cancer Test, CellMax-LBx Liquid Biopsy for immunotherapy and targeted therapy selection and CellMax-PanCa Monitoring Test. All clinical testing is performed at CLIA and CAP accredited laboratories in Sunnyvale, California and Taipei, Taiwan.
For additional information, please visit http://www.cellmaxlife.com.
Michael Simmons (Media Contact)