Company raising $50 million Series C round and in early stages of securing reimbursement for test.
By ALARIC DEARMENT
Sunnyvale, California-based CellMax Life said Tuesday it was granted the patents for its CMx biomimetic platform, which is designed to detect circulating tumor cells (CTCs) in the blood. It is designed as a CLIA-based test run from a central laboratory and ordered by the physician, and the company anticipates Food and Drug Administration and Medicare approval in the next two to three years.
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.
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.
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.
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.
SUNNYVALE, CALIF. (PRWEB) MARCH 28, 2018
CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, announced today the U.S. launch of a blood test to detect the expression of PD-L1 – a key protein involved in suppressing the immune system – in circulating tumor cells (CTCs). Since immunotherapies work only on a minority of patients, identifying cancer patients expressing the PD-L1 protein in CTCs can help determine if they will benefit from the treatment, sparing significant costs and potential side effects.
A study on early and late stage lung cancer patients was recently completed, and the data will be shared at the upcoming American Association for Cancer Research (AACR) conference in Chicago on April 14 through 18. The test was able to capture CTCs for PD-L1 testing in blood in about 90 percent of tested patients. Conversely, tissue can be insufficient or unavailable for testing in 25 to 50 percent of advanced lung cancer patients. About 50 percent of the CTC tested patients were PD-L1 positive; this is consistent with previously reported PD-L1 positivity rates in clinical studies.
Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis, said: “PD-L1 testing by immunohistochemistry is a standard of care as a predictive biomarker for checkpoint immunotherapy. Blood-based testing offers three potential advantages. First, about 25 percent of patients have inadequate tumor tissue upfront to test for both molecular biomarkers and PD-L1. Second, PD-L1 is a dynamic biomarker, which can change over time, so using tumor from a prior biopsy may be misleading. PD-L1 can also be unevenly distributed in tissue, leading to a false negative and denying patients the opportunity to receive immunotherapy. Lastly, looking to the future, blood-based testing provides a means for repeat testing and timely monitoring, which would not be possible otherwise. A PD-L1 blood test can overcome current issues and would be an attractive alternative to tissue testing.”
“For the 1.7 million people diagnosed with cancer annually in the United States, and the 14.8 million people living with cancer there is no affordable, non-invasive and effective way to monitor patients for treatment response or cancer recurrence,” said Atul Sharan, CEO of CellMax Life. “With the invasiveness of tissue testing and high costs and limitations of existing DNA-based liquid biopsies, conducting repeat testing has been impractical, and often, impossible. CellMax CTC blood tests offer a solution to this major unmet need. We are also seeing a lot of interest from biopharmaceutical companies who want to partner with us to de-risk their clinical trials by using CTCs to monitor patients and identify non-responders to their drug early.”
CellMax Life also analyzes circulating tumor DNA (ctDNA) in the blood sample. The combination of DNA and CTC analysis makes the CellMax liquid biopsy the first and only blood test that includes all mutation classes recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for immunotherapy and targeted therapy selection in patients with advanced solid tumors.
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.
Theranos Inc.’s fall underscores the need for medical startups to be transparent in their dealings with investors and to publish data supporting their technology to gain credibility, venture capitalists and entrepreneurs said.
Theranos, formed in 2003, climbed to a valuation of more than $9 billion, partly by telling investors it had developed a portable blood analyzer that could conduct the full range of laboratory tests using only finger drops of blood. Along the way, the company enforced what some former employees described as a culture of secrecy, and some employees were leery about the accuracy of its technology, The Wall Street Journal has reported.
Founded by Elizabeth Holmes, Theranos has been under scrutiny since the Journal reported in October 2015 that the company relied heavily on other companies’ instruments and used its linchpin lab machine in only a small portion of the tests sold to consumers. Regulators began investigating soon after, and on Wednesday, the Securities and Exchange Commission said it had filed civil fraud charges against Ms. Holmes,
Theranos and its former president. The SEC accused them of raising more than $700 million from investors through “an elaborate, yearslong fraud in which they exaggerated or made false statements about the company’s technology, business, and financial performance.” To settle the charges, Ms. Holmes has agreed to pay a $500,000 fine and has been stripped of voting control over the company. She is also barred from being an officer or director of a public company for 10 years.
The SEC settled charges with Theranos and Ms. Holmes but not with Theranos’s former president, Ramesh “Sunny” Balwani. Mr. Balwani’s lawyer, Jeffrey B. Coopersmith, said in a statement: “Sunny Balwani accurately represented Theranos to investors to the best of his ability. He believed in the potential and mission of the company and its technology to promote transparency and benefit people by empowering them with access to their own health care information at a low cost.” The Newark, Calif., company and Ms. Holmes neither admitted nor denied the SEC allegations, the agency said.
“The company is pleased to be bringing this matter to a close and looks forward to advancing its technology,” Theranos’s independent directors said in a statement. Investors and entrepreneurs said cases of alleged fraud must have consequences. Successful life-sciences entrepreneurs, they said, usually have significant clinical, research or corporate expertise, and medical startups must publish their research data to establish themselves. In hindsight, Theranos’s business proposition might have been more solid had Ms. Holmes first worked at a large blood-testing company where she was tasked with finding and developing new technology, said Kevin Kinsella, founder of technology and biopharma investor Avalon Ventures, which didn’t invest in Theranos. He said Theranos’s claims about its technology seemed outlandish from the start. “This was fraud from the get-go,” Mr. Kinsella said. When backing entrepreneurs, he added, “We look for someone who’s done it before with someone else’s money.” Some entrepreneurs said too much hype for unproven technology can hurt budding sectors by creating unrealistic expectations.
“There should not be any shortcuts when it comes to bringing a product to market in medicine,” Atul Sharan, chief executive of cancer-diagnostics startup CellMax Life, said in an email. “Our eye has to always be on the patient, not the dollar sign.” CellMax pursues an emerging approach to cancer testing that involves scanning for markers in the blood known as circulating tumors cells and circulating tumor DNA.
Tom Rodgers, who leads McKesson Ventures, which didn’t invest in Theranos, said via an email that his firm isn’t doing anything different in the wake of the Theranos fallout,adding that most traditional, early-stage health-care-only venture capitalists already perform fairly robust diligence. Added Mr. Rodgers: “It would be a big red flag if a CEO said, ‘We can’t show you our secret sauce.’”