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.

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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.

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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.

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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.’”

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