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.”
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.