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.
NEW YORK (360Dx) – CellMax Life announced this week that it is beginning a new clinical trial, which will further validate its circulating tumor cell (CTC) colorectal cancer screening test in American subjects, with the goal of supporting a submission for approval by the US Food and Drug Administration.
The study is being conducted with a handful of medical centers, including Stanford Medicine, the US Department of Veterans Affairs, Johns Hopkins, and the University of Southern California. CellMax’s CRC screening test is currently only available in Asia, where it has been offered for about two years, but the company has had plans in place for some time to bring the assay to the US market. CEO Atul Sharan said in an interview that the company expects to complete the analytical validation study, along with additional algorithm development work, by the end of this year.
While the company waits for this process to play out, Sharan said that it intends to launch a version of the assay before the end of this year as a laboratory-developed test through its CLIA lab.
“We have been seeing a lot of demand from labs, physicians, and patients following [our presentation this January],” he said.
CellMax has stated that its CMx platform, which involves what the company has described as a “chaotic mixing microfluidic chip,” isolates rare CTCs present at a fraction of 1 to 10 CTCs in a background of one billion normal cells. The current CRC screening application is based simply on the presence or absence of CTCs, although the platform does allow for follow-on genomic or other molecular analyses of captured cells.
This January, the company shared results at the 2018 ASCO Gastrointestinal Cancer Symposium from a prior validation study in Asian subjects, which found that its test could detect colorectal cancer at an early stage with accuracy ranging from 84 to 88 percent in a cohort of 600 individuals recruited at Taiwan’s Chang Gung Memorial Hospital. The new US trial would confirm that the test also works in a non-Asian population and is also positioned to answer some lingering questions that were not addressed in the previous study. For example, the new validation is being conducted in an intended-use population, whereas the Taiwan study cohort did not reflect a real-world screening population.
According to Sharan, the way subjects were recruited in the Taiwan trial resulted in a cohort that was weighted toward symptomatic patients. Despite this, he argued that clinicians at the ASCO GI meeting responded very positively to the results. Sharan said that the new US study will recruit between 3,000 and 5,000 individuals of either sex, who are 50 years or older and are coming in for routine colorectal cancer screening via currently available colonoscopy or stool tests.
Study participants who consent will be tested in parallel using CellMax Life’s blood test and whichever standard-ofcare screening they were already slated to receive. Researchers will then compare results of the blood test with the outcomes of subjects’ colonoscopy or stool analyses.
According to Sharan, CellMax is working with the FDA to define the details of the study and to make sure that it is designed in a way that the appropriate data can be collected to submit the test for regulatory approval. He also said that the company plans to pursue a parallel review pathway, seeking a simultaneous FDA approval and coverage determination for the test from the US Centers for Medicare and Medicaid Services. In the interim, the firm intends to begin offering an LDT before the end of this year, under a self-pay model with an approximately $200 price point. This would potentially put it into competition with the FDA-approved Epi proColon test, a PCR-based blood test marketed by Epigenomics at similar prices. Epi proColon, which has reported up to about 68 percent sensitivity and 80 percent specificity, has struggled to gain a foothold in clinical practice, but based on the data from CellMax’s Taiwan study, the company’s CTC methodology appears to offer improved accuracy, prompting excitement among some clinicians that the CellMax test could succeed where earlier blood tests have struggled.
“After CellMax Life’s blood test showed such impressive results at ASCO GI, we believe it can address the unmet need for a convenient, accurate, and affordable test for early colorectal cancer detection. I expect physicians will adopt it as a first-line screening option for all patients, with colonoscopy as the confirmatory diagnostic for patients who are positive per the CellMax test,” Shai Friedland, the lead PI of the newly announced CellMax study and chief of gastroenterology and hepatology a the VA’s Palo Alto Health Care System, said in a statement.
As an LDT, the CellMax test would also potentially compete with Exact Sciences’ FDA-approved stool-based genetic screening test, Cologuard, which offers about 94 percent sensitivity in detecting stage I and II cancers, but only up to 69 percent in high-grade precancers. CellMax Life’s Taiwan study data suggests it might have better performance in detecting precancers, but it remains to be seen whether the same results will hold up in the larger, more real-world cohort of its planned US follow-up.
Sharan has emphasized the potential of the test, regardless of whether it can outperform Cologuard, to improve patient outcomes via increased screening compliance. He reiterated that about a third of Americans have never been screened because current testing options, including stool-based tests, are too invasive or inconvenient.
As CellMax moves forward, the cancer screening field is also anticipating the entrance of other new tests that provide early detection via analysis of various biomarkers in blood. Freenome, for example, recently announced the commencement of its first clinical validation study, which it calls AIEMERGE, intended to support the launch of a screening test that is also being designed for use in colorectal cancer.
Information about the methodology, content, or structure of the CRC test that Freenome’s artificial-intelligence approach may yield is not yet available, but Sharan said that the evidence so far from existing approaches that profile DNA or other molecular biomarkers in blood, suggests that early cancer detection can require analyses that are much less cost-effective than the CTC approach CellMax has taken.
That said, CellMax is also continuing to explore whether there might be added value in coupling its CTC enumeration with other analytes. But according to Sharan, the results of the firm’s algorithm development work are expected to support a test that is limited to CTC enumeration and clinical variables like patient-age.
Sharan said that the company is prioritizing the newly announced colorectal cancer study, but has a number of other arms proceeding in the background. These include development of a CTC-based assay for PD-L1 expression, which the company has made available for clinical use in Asia and for research use only in the US.
According to CellMax, early data suggests that it can isolate intact CTCs in about 90 percent of non-small cell lung cancer samples, with PD-L1 positivity rates in line with what has been published in the literature from tissue analysis, and high concordance with matched tissue testing.
The firm has also presented data recently on a CTC-based prostate cancer test it is developing that can help identify or rule out cancer in men who have intermediate PSA test results, as well as provide a platform for non-invasive analysis of prognostic markers.
SUNNYVALE, Calif., May 30, 2018 /PRNewswire/ — CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, today announced it is commencing Zenith, a U.S. clinical study for its circulating tumor cell (CTC) blood test, which can transform the way colorectal cancer is detected, enabling diagnosis at its earliest, most treatable stages.
To do this, the company is first initiating a study with leading U.S. medical centers including Stanford Medicine and the U.S. Department of Veterans Affairs Palo Alto Health Care System, Johns Hopkins and University of Southern California. This U.S. trial comes on the heels of an Asian trial, for which results were announced at the 2018 ASCO Gastrointestinal Cancer Symposium (ASCO GI) in January, which demonstrated that the test can detect colorectal cancer at an early stage with accuracy ranging from 84 to 88 percent.
In this study, thousands of patients coming in for routine colorectal cancer screening via colonoscopy or stool tests will be offered CellMax Life’s blood test. The results of the blood test will be compared to those from the colonoscopy and stool tests.
“We plan to work closely with the FDA upfront to define the details of this study,” said Atul Sharan, CEO of CellMax Life. “We will also pursue reimbursement for the test by submitting it through the Parallel Review Program for approval from the FDA and coverage determination by Centers for Medicare and Medicaid Services (CMS). The test requires just a single tube of blood and is at a price point of less than $200, which makes this a very practical solution for colorectal cancer screening.”
“Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second deadliest cancer in the United States partly because of lack of compliance. One in three eligible Americans have never been screened because current testing options like colonoscopies and stool-based tests are invasive or inconvenient, deterring people from getting screened,” said Shai Friedland, M.D., Chief of Gastroenterology & Hepatology, VA Palo Alto Health Care System from the Stanford University School of Medicine, as well as lead principal investigator (PI) on this study. “After CellMax Life’s blood test showed such impressive results at ASCO GI, we believe it can address the unmet need for a convenient, accurate and affordable test for early colorectal cancer detection. I expect physicians will adopt it as a first-line screening option for all patients, with colonoscopy as the confirmatory diagnostic for patients who are positive per the CellMax test.”
While testing for CTCs has been approved and validated by the FDA as a useful detection method for late stage metastatic cancer, there has not yet been a CTC technology with the sensitivity required for early cancer detection. CellMax Life’s CMx™ ultra-sensitive CTC platform, which isolates rare CTCs present at a fraction of 1 to 10 CTCs in a background of one billion normal cells in pre-cancer and early stage cancer breaks this barrier. This platform has eight patents and is the only clinically proven CTC platform able to detect cancer early.
“The ASCO GI results showed that the blood test can detect pre-cancerous lesions at a higher sensitivity than stool tests. This is significant because these lesions can be safely and easily removed with a follow-on colonoscopy. Also, unlike home stool tests, which in our experience are only completed by around 30 percent of patients that order the kit, this test can be easily integrated into a patient’s annual physical exam, increasing compliance,” said Ashish Nimgaonkar, M.D., a gastroenterologist, medical director at the Center for Bioengineering Innovation & Design at Johns Hopkins University and one of the PIs on this study.
“An affordable test with keen sensitivity for early cancer detection like the CTC blood test has the potential to transform cancer diagnostics,” said Dr. Heinz-Josef Lenz, Medical Oncologist, Professor of Medicine at the Keck School of Medicine, USC. “The potential applications can go well beyond early detection to monitoring treatment efficacy and detect resistance to therapies, as well as for recurrence monitoring for 15 million Americans who have been diagnosed with cancer.”
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 www.cellmaxlife.com.
Under the agreement, CellMax will combine its technology for CTC isolation with IncellDx’s proprietary BioINK microfluidic reagents. Tests will be processed at CellMax’s CLIA lab in Sunnyvale, California and will be jointly marketed in the US by its sales force.
Additional terms of the agreement were not disclosed.
CellMax CEO Atul Sharan said in a statement that IncellDx’s reagent platform will bring “tremendous added value” to its tests. The first project will be to commercialize a blood-based PD-L1 assay based on analysis of both RNA and protein in captured CTCs, to be used in immunotherapy selection and monitoring.
The first generation of tests developed to measure PD-L1 required a biopsy sample of a patient’s tumor. Because blood-based testing is less invasive, easier, and can be performed repeatedly, it offers potential advantages over available assays.
CellMax and IncellDx intend to present performance data for their CTC-based PD-L1 test in non-small cell lung cancer at the annual meeting of the American Association for Cancer Research later this month.
According to the companies, the CellMax technology has been able to capture CTCs for PD-L1 testing in about 90 percent of patients across all stages of NSCLC, with about 50 percent testing PD-L1 positive.
