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.
NEW YORK (GenomeWeb) – JAN 02, 2019
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.
Antenna Group
Michael Simmons (Media Contact)
CellMaxLife(at)antennagroup.com
201-465-8030
Chicago Tribune | June 27, 2018 —
Medical tests save lives. Discovering diseases before they become more serious can mean the difference between life and death. But many Americans say they don’t have time to see a doctor, live too far from a medical facility or are so uncomfortable with examinations that they avoid tests altogether.
These challenges have created a demand for home-based medical tests. The market is exploding as businesses bet that consumers prefer the convenience and privacy of home testing.
Scientific American | June 20, 2018 —
Colorectal Cancer Is on the Rise in Young Adults
They’re reluctant to have invasive colonoscopies, but a simple blood test could improve compliance
By Shai Friedland
There has been increasing attention directed towards the rising rate of colorectal cancer in younger age groups. In the United States, there was a 51 percent increase in colorectal cancer incidence in adults younger than 55 years old between 1994 and 2014. Partly in response to this alarming trend, the American Cancer Society (ACS) lowered the recommended age at which to begin screening from 50 to 45. Several screening options exist, although the two prominent ones in the United States are colonoscopy and fecal immunochemical tests (FIT), stool tests that detect small amounts of blood. In practice, FIT is used to select a subset of patients for colonoscopy—those with a higher amount of blood in the stool than the threshold set by the laboratory, as blood in the stool is commonly associated with cancer.
MedTech Breakthrough Awards, 2018 — Leading Cancer Management Company Wins Prestigious Award for its Proprietary Circulating Tumor Cell (CTC) CMx Platform
CellMax Life, a leading cancer detection and management company with clinically proven, affordable and non-invasive early cancer detection blood tests, announced today that its proprietary CMx™ circulating tumor cell (CTC) platform has won the 2018 MedTech Breakthrough Award for Best New Technology Solution in Cancer Management. CellMax Life was chosen from over 3,000 nominations, placing it among the organization’s previous winners that include leading medical technology companies such as 23andMe, WebMD, Samsung, Stryker, Apple, IBM Watson, Humana and Zocdoc.
“We are honored to win this award and receive this respected recognition for our CMx platform,” said Atul Sharan, CEO of CellMax Life. “Our CMx platform gives patients and physicians the ease, accuracy and affordability that an early cancer detection test should have, and we are hopeful that adoption of this proven technology will substantially improve cancer survival rates in the country. Adoption of screening dramatically impacts mortality rates from cancer. The best example of this is probably cervical cancer, which was once one of the most common causes of cancer death for American women. However, since the onset of widespread PAP screening the cervical cancer death rate has dropped by 60%”
Colorectal cancer is among the most preventable cancers, with greater than 90% survival rates when detected early. Yet it is the second leading cancer killer in the United States. Screening tests such as colonoscopies and stool-based tests for colorectal cancer are either invasive or inconvenient and serve as a deterrent for routine screenings, with statistics demonstrating that one in three eligible Americans have never been screened for colorectal cancer. As a result, most colorectal cancer is diagnosed when the cancer is already advanced. Survival rates for colorectal cancer that has spread to other organs are only 14%. Blood tests may offer a solution. Published surveys suggest that patients who are reluctant to undergo colonoscopy screenings are very receptive to blood tests. In fact, over 83 percent of those surveyed preferred a blood test over a stool test.
Circulating tumor cells or CTCs are cells that shed from a tumor and circulate into the bloodstream very early in cancer development. However, they are very rare in early stage cancer, presenting in fewer than five cells in a background of one billion cells, and until now have been virtually impossible to detect with high accuracy. The globally affordable CellMax Life blood test aims to transform early cancer detection and management with a platform that isolates these rare CTCs with a single blood sample. The CMx platform provides an accessible and affordable alternative for the 85 million individuals who are eligible for routine cancer screenings.
The CMx platform has eight patents for its proprietary technology that contains a microfluidic chip with lipid coating mimicking the human epithelium, proprietary antibodies, gentle air-foam based cell release, and advanced imaging, capturing CTCs in up to 90 percent of early stage cancer patients across cancers such as colorectal, prostate and lung. A study announced by the American Society of Clinical Oncology (ASCO) showed that the accuracy of the test ranged from 84 to 88 percent for the detection of early stage colorectal cancer and pre-cancer. Additionally, the platform’s successful detection of prostate cancer could help reduce unnecessary invasive biopsies by up to 90 percent in patients receiving indeterminate results following a PSA screen by clarifying what patients need the procedure.
“An affordable test with keen sensitivity for early cancer detection like the CTC blood test has the potential to transform cancer diagnostics,” said Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis. “The potential applications can go well beyond early detection to guiding treatment selection for patients diagnosed with cancer. This CTC test can detect the expression of PD-L1 – a key protein involved in suppressing the immune system. Patients who express this protein have better response rates to immunotherapy treatment that those who do not express this protein.”
About CellMax Life
CellMax Life is a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management. 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.
About MedTech Breakthrough
The MedTech Breakthrough Awards program is devoted to honoring excellence in medical and health related technology companies, products and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough MedTech companies and products in categories including Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit http://www.MedTechBreakthrough.com.
Antenna Group
Michael Simmons (Media Contact)
CellMaxLife(at)antennagroup.com
201-465-8030
Becker’s GI & Endoscopy | May 30, 2018
Cancer diagnostics company CellMaxLife launched Zenith, the U.S. trial of its circulating tumor cell blood test to detect colorectal cancer.
Here are four things to know:
1. Patients coming in for routine colorectal cancer screening through colonoscopy or stool tests will be offered CellMaxLife’s blood test, and the results will be compared to the colonoscopy and stool test results.
2. CellMaxLife is partnering with medical centers such as Stanford (Calif.) Medicine, the U.S. Department of Veterans Affairs Palo Alto (Calif.) Health Care System, Baltimore-based Johns Hopkins and the University of Southern California in Los Angeles for the study.
3. A previous trial in Asia found that the test can detect colorectal cancer at an early stage with between 84 and 88 percent accuracy, according to results presented at the 2018 ASCO Gastrointestinal Cancer Symposium in January.
4. CellMaxLife will pursue reimbursement for the test by submitting it through the Parallel Review Program for FDA approval and CMS coverage determination. The test requires one tube of blood and is at a price point of less than $200.
ASCO Reading Room A new blood test appears to detect expression of the programmed death-ligand 1 (PD-L1) protein in circulating tumor cells (CTCs) with high sensitivity, enabling repeat testing to monitor a patient’s response to immunotherapy throughout the course of treatment.
The test is able to capture CTCs for PD-L1 testing in blood in about 90% of patients, the researchers said. About half of the CTC-tested patients were PD-L1 positive, which is consistent with previously reported PD-L1-positivity rates in clinical trials.
