NEW YORK (GenomeWeb) – CellMax Life's focus on developing a blood-based cell detection platform to detect pre-cancer and cancer at an early stage is one of its main differentiating points in an increasingly crowded market, a company executive said last week on the sidelines of the 37th annual JP Morgan Healthcare Conference.
That capability is one of the primary reasons that Taiwan-based Medigen Biotech recently selected the company as a partner for upcoming cell therapy clinical trials, according to Padma Sundar, vice president of strategy and market access at CellMax.
Separately, the firm announced today it would present new findings at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco this week highlighting the results of an expanded study that shows its CMx blood biopsy platform can detect pre-cancers, or adenomas, with close to 90 percent accuracy.
In the meantime, Medigen is integrating CellMax's CMx circulating tumor cell platform with its circulating tumor DNA-based liquid biopsy panel to examine patient treatment selection and response.
The biotech firm had an option to select other competitors developing and marketing liquid biopsies but the CellMax platform's sensitivity for early-stage detection led to its selection, Sundar said.
As part of the open-label, multicenter, single arm clinical trial, the collaborating team plans to enroll patients with stage II and III colorectal cancer that has been surgically resected, or surgically resected and treated with chemotherapy.
CellMax is moving along a path to commercialization that involves developing and applying its CTC platform for early detection not only for colorectal cancer, but more long term, for breast and prostate cancer, Sundar said.
In May, the firm began a new clinical trial to further validate its circulating tumor cell colorectal cancer screening test in American subjects, with the goal of supporting a submission for approval by the US Food and Drug Administration.
Sundar said that the trial will enroll several thousand individuals 45 years and older who will receive the blood test, and clinicians will compare the test's performance with colonoscopy results. The firm will then submit data as part of an application to obtain regulatory premarket approval from the FDA, but the anticipated timeline to obtain clearance has not been disclosed, Sundar said.
During the fourth quarter of this year, the firm anticipates launching its CRC screening test from a CAP-accredited, CLIA-certified laboratory in Sunnydale, California.
It will seek reimbursement for all of its tests, Sundar said.
The company also announced it will present findings for the CMx blood biopsy platform at the ASCO symposium this week. Results of the study, based on a measurement of accuracy using area under the ROC curve, show that it is possible to accurately differentiate between healthy patients and those with pre-cancer based on enumeration of pre-cancer cells.
Further, an increase in cell count was significantly correlated with an increase in disease severity, CellMax added.
Atul Sharan, cofounder and CEO of CellMax, said in a statement that adenoma removal reduces mortality rates from colorectal cancer by 53 percent. "CellMax Life’s FirstSight CRCtest will increase compliance with colorectal cancer screenings and increase detection rates at the adenoma stage, saving lives," he said.
To detect pre-cancer and cancer cells in blood, the FirstSightCRC test uses a microfluidic chip with a non-sticky nanolayer for cell capture, high-affinity antibodies, and an air-foam technology to gently release the captured cells enabling high intact cell preservation, thereby achieving high-detection rates of pre-cancer, CellMax said.
CellMax's blood test isolates and analyzes both CTCs and cell-free DNA from a blood sample to detect six types of analytes, including four classes of genomic mutations, microsatellite instability, and CTCs.
The IRB-approved study included 737 adults, 50 years of age or older — a population that most US guidelines recommend have routine screening, CellMax noted.
Of those, 301 were found to be healthy, 111 had pre-cancers, and 325 had cancer. Diseased patients were confirmed by colonoscopy or tumor biopsy. The test results presented a high accuracy for detecting colorectal cancer with a close to 90 percent accuracy for pre-cancer and 95 percent accuracy for cancer, the firm said.
The firm had presented previous test results at ASCO’s Gastrointestinal Symposium in 2018.