March 15, 2015 (Vol. 35, No. 6)
Cynvenio Biosystems’ Diagnostic Platform Analyzes cDNA, Captures Cancer’s Dynamism
Cynvenio Biosystems, with its LiquidBiopsy® rare cell isolation and genomic analysis platform, is at the forefront of cancer diagnostics. Rather than rely on tissue biopsies or counting circulating tumor cells in the blood, this technology extracts and sequences those cells’ DNA. That, in turn, makes possible real-time analysis of specific alterations within tumors that affect treatment decisions.
Historically, blood draws have merely counted circulating tumor cells. “That doesn’t provide a decision point,” says Paul Dempsey, Cynvenio’s CSO. The molecular analysis of circulating tumor cells, however, enables physicians to design treatment regimens based upon their molecular character and, thus, improve outcomes.
Not only are blood samples easier to obtain, but “blood draws let physicians sample tumor cells at intervals through patients’ treatment, remission, and potential recurrence,” Dr. Dempsey explains. “Cancer is a dynamic, quickly moving disease that needs to be monitored over time.
“When a disease is distributed, you don’t know where it is,” he continues. “For example, metastatic disease manifests in places that are difficult to sample, such as the bone.”
A standard tissue biopsy is static and provides a view of the cancer that is not informed by biology. In contrast, blood biopsies allow physicians to see the entire disease rather than just a biopsy site, thus allowing a broader understanding of the cancer and its complexity. LiquidBiopsy monitors aspects of the disease that are linked to many of the worst outcomes.
The utility of a broad biopsy approach is supported by multiple studies. One reviewed kidney disease and looked at differences in tissues from small biopsy sites.
“They reflected selection pressure based on treatment and metastasis,” Dr. Dempsey says. “There also is a large body of evidence in breast, prostate, and colorectal cancer that shows that circulating cancer cells are prognostic for disease outcomes and are, in fact, driving the disease.” He adds that, ultimately, all solid tissue cancers are deadly because they metastasize.
“LiquidBiopsy is unhinged from the constraints of traditional tissue biopsies,” Dr. Dempsey points out. “It is location insensitive.”
The use of blood draws to detect cancer is gaining ground. The European Medicines Agency granted a CE mark in January to a competing technology.
“There are a number of different blood-based templates being developed that open different windows into the disease process,” Dr. Dempsey notes. “All will drive a major revolution in how we treat patients,” possibly replacing traditional biopsies and standard treatment regimens.
LiquidBiopsy is based upon enhanced immunomagnetic capture and a proprietary microfluidic chip to recover cells from whole blood. The cells can be removed from the chip for immediate PCR and next-generation sequencing without the need for whole genome amplification or similar steps. The automated platform can process four samples within three hours. It is being deployed first to detect circulating colorectal, breast, and prostate cancer cells. Tests for other cancers are in development.
In January, Cynvenio announced a collaboration with Thermo Fisher Scientific to distribute LiquidBiopsy to large research institutions and hospitals. The system became commercially available to hospital laboratories in late 2014, following its introduction the previous year as a CLIA-certified laboratory service for physicians and pharmaceutical companies.
“Our CLIA laboratory showed us numerous instances in which doctors had no solid evidence with which to make rational treatment decisions,” states Dr. Dempsey, who added that operating this reference laboratory in-house brought additional benefits. It gave the Cynvenio developers first-hand familiarity with the issues and opportunities. As Dr. Dempsey says, “You can’t build up real knowledge without working the problem first-hand yourself.”
The technology is buoyed by the commercialization of next-generation sequencing and other discovery tools that have been pioneered by major research institutions and developed to respect the growing cost-consciousness of payers. “Amazing next-generation sequencing tools are providing actionable information to hone in on useful readouts,” Dr. Dempsey asserts. Simultaneously, the healthcare system’s increasing cost consciousness makes it undesirable to perform unnecessary tests.
According to Dr. Dempsey, the monitoring of disease through blood reads makes inherent economic sense.
“Our technology leverages the biological discoveries of the past 20 years and dovetails with next-generation sequencing,” continues Dr. Dempsey. “We’re the only commercial group, to my knowledge, to generate tumor cell populations as a template from a blood sample that can be molecularly analyzed.”
The work to molecularly characterize tumors has segmented disease into different populations that should be based on the cause—a disruption in the mTOR pathway, for example—rather than their location. Liquid Biopsy, as a molecular tool, does that.
LiquidBiopsy is on the path to mainstream usage, buoyed by the efficacy of molecular data in improving outcomes. “Now researchers are beginning to build adaptable clinical trials rather than look for subpopulations of patients,” Dr. Dempsey reports. As they become more numerous, they will enable “more complex clinical trials with multiple arms based on molecular readouts.” As those results accrue, they will provide added validation that molecular information is a reliable predictor of the outcome of targeted therapies.
Location: 2260 Townsgate Road, Westlake Village, CA 91361
Phone: (805) 777-0017
Principal: André de Fusco, CEO and Director
Number of Employees: 28
Focus: Cynvenio Biosystems is a molecular information technology company. Its lead product, LiquidBiopsy, provides genomic analysis of tumor cells circulating in the bloodstream.