Santa Cruz, CA and Washington, DC – August 16, 2017 – Two Pore Guys, Inc. (2PG) today announced positive results from its pilot liquid biopsy study with the University of California, San Francisco. The retrospective study confirmed the company’s handheld nanopore-based sensor technology detected cell-free, circulating tumor DNA (ctDNA) from blood and urine samples in patients with colorectal or pancreatic cancer whose tumors were previously confirmed via DNA sequencing of biopsied tissue to harbor a known point mutation called KRAS G12D.
Results of the study were presented yesterday at the Next Generation Dx Summit by investigator Andrew Ko, MD, a Professor of Hematology/Oncology and a specialist in gastrointestinal cancer at the UCSF Helen Diller Family Comprehensive Cancer Center.
This is the first time a hand-held testing system was used in a liquid biopsy test. In the nine-patient study, blood samples were provided by all patients and urine samples were also available from five patients. The KRAS G12D mutation was detected in all nine blood samples, but more importantly, the mutation was detected in all five urine samples, emphasizing the viability of a small, low-cost system that could be used without requiring blood draws. Even more significantly, the process directly determined the mutant allele frequency, which is essential for clinical use in determining therapeutic treatment. 2PG also performed comparison studies to predicate platform qPCR assays and obtained similar results.
“Two Pore Guys has developed a fascinating technology that really offers the promise of point-of-care liquid biopsy. I’m looking forward to its future potential in many different clinical capacities, including in the oncology arena,” said Dr. Ko. “Based on the results of this proof-of-concept study, we are one step closer toward using this technology more broadly, such as in a patient’s own home. While there is still a lot to be worked out, I and others in the cancer research field are tremendously excited about this approach.”
Trevor Morin, Ph.D., Chief Scientific Officer of Two Pore Guys commented, “A major focus of 2PG is being able to facilitate self-administered tests across a large number of biomarkers from easily collected biofluids, such as urine, saliva and nasal swabs. In this study, the ability to measure ctDNA from urine with sensitivity levels suitable for clinical decision-making is unprecedented for a device that anyone can use. It’s also a much faster, more cost-effective alternative to traditional methods, such as next generation sequencing (NSG), microarray analysis, and qPCR. We are proud to have developed the first handheld device for real-time cancer monitoring.”
Dan Heller, Chief Executive Officer of Two Pore Guys added, “One of the very exciting things about our innovation is that it provides the practical ability to do serial monitoring -- whether it be daily, weekly, or monthly clinicians can monitor the patient’s response to treatment. In our study, we demonstrated how mutation status can change over relatively short periods of time, suggesting a benefit for testing frequently. We are grateful to Dr. Ko and his patients for helping us demonstrate the power of our unique approach.”
2PG’s novel use of solid-state nanopores enables digital, single-molecule sensing in a small, inexpensive, and simple-to-use form factor. The devices transmit data wirelessly to authorized systems and cloud infrastructures, thereby enabling such uses as telemedicine, clinical trials for drug development, and global tracking of pathogens and diseases. Target uses include human and animal diagnostics, agriculture, food safety testing, environmental monitoring, regulatory, and defense.
The company has begun collaborating with companies across multiple markets that plan to develop tests for the platform, similar to how software developers make apps for smartphones. Specific assays are developed by third parties to detect virtually any kind of molecule. Even existing tests made for traditional centralized lab equipment can be adapted to 2PG’s platform, allowing for a potentially unlimited menu of high-sensitivity tests to reach the market. 2PG manufactures the reader devices and test strips that incorporate the reagents from a partner’s assays, which are then sold through master distributors.
Two Pore Guys (2PG) has developed a handheld, single-molecule sensing platform with the accuracy, precision, and sensitivity of reference lab equipment and sample-in, results-out capability. The core technology includes solid-state, nanopore-based sensors that can detect nucleic acids and proteins and other analytes in human, animal, agriculture, and environmental samples. The battery-operated device is ideal for point-of-use applications. The easy-to-use platform is designed to sync with a smartphone or computer for further analysis and data sharing, including integration with electronic health records. Founded in 2011, the company is based in Santa Cruz, Calif. More information is available at twoporeguys.com.