Liquid biopsy in the palm of your hand

Two Pore Guys and UCSF collaborate on study with first handheld device for cancer monitoring

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SANTA CRUZ, Calif.—Two Pore Guys Inc. (2PG) has recently announced that the company is collaborating with oncologists at the University of California, San Francisco (UCSF), to evaluate its handheld nanopore-based platform in the detection of cell-free, circulating tumor DNA (ctDNA) from patient liquid biopsies. 
The study, conducted by Dr. Andrew Ko, will focus on detecting the KRAS G12D mutation among ctDNAs obtained from patient blood and urine samples. If successful, the new device could be a revolutionary way to monitor patients for the recurrence of cancer from home on a daily basis.
“2PG’s platform is ideal for applications like liquid biopsy because it is portable, simple and inexpensive enough to be used by anyone, anywhere,” said Dan Heller, president and CEO of 2PG. 
Liquid biopsy is already a widely used tool to assist in treatment decision-making in metastatic lung cancer. It is also an emerging approach to facilitate the diagnosis and potentially the monitoring of other cancers, offering the promise of less-invasive testing of tumor DNA using an easily attainable biological sample, such as blood or urine.
Two Pore Guys—which according to Heller ended up with its uniquely punny name from a nickname William Dunbar (chief technology officer at 2PG) and Heller used while at University of California, Santa Cruz—now has a handheld platform composed of a battery-operated reader device and disposable test strips containing reagents and solid-state nanopore chips that detect individual molecules, one by one. 
The device is said to be 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.
Heller tells DDNews that 2PG’s device is unique, in that it can test a multitude of things. “Depending on what you’re looking for, you’d test different sample sources. If you’re looking for proteins in blood, test blood. For MRSA, you’d use a nasal swab. We can detect GMOs in seeds—DNA is DNA. Once it goes through a nanopore, we can see it. So the question is what you’re looking for.” 
“Solid-state nanopore just means it’s a piece of silicon with a small hole. We can use larger DNA lengths, not just a single strand. Nobody really discovered a way to commercialize these devices until we did. When we met Trevor [Trevor Morin, chief scientific officer at 2PG], we came up with a lot of our IP [intellectual property] and business strategy,” Heller continues. 
Morin says, “What it’s important to realize is that our device has a number of uses due to its modularity. It allows you to plug into all different stages of research, drug discovery being just one of them. Once you understand how our technology works, you can screen a large number of molecules to find a potential compound. We can test patients quickly to see if they respond to a drug. We can measure how long it stays in their system. We can look for the pathogen itself to see if the viral load is increasing or decreasing, or measure antibodies in the blood. So you no longer need to have patients come into the lab for blood draws, but you can have patients test at a convenient clinic.”
“David Haussler, the chair of our scientific board, has a lot of connections in different areas. We were making a lot of significant progress, but because of our commercial partners at the time, we weren’t allowed to talk about it,” Heller explains. “David and I were discussing, ‘Why don’t we partner up with some oncologists at UCSF?’ We talked to a number of people, and we ended up working with Andrew Ko.”
“Cancer recurrence is a constant battle, and treatment is a race against time,” said Ko, who is a professor of hematology/oncology and a specialist in gastrointestinal cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. “The sooner we can detect a recurrence, the sooner we can change or augment a patient’s therapy and improve his or her chances of survival.”
For this collaboration, 2PG will concentrate ctDNA from the patient samples using existing extraction kits, though the company is developing an integrated solution. While 2PG made the reagents for its liquid biopsy assay, it is a proof-of-concept test. The company manufactures devices and test strips, but does not intend to go to market with its own assays. 2PG’s core IP defines how to make reagents that work with third-party diagnostic chemistries, thereby allowing industry partners to adapt existing assays and to enter new markets on 2PG’s platform. 
“We have high hopes for liquid biopsy as an important tool in the future of cancer treatment,” Ko added. “The ability to accurately monitor mutations using a simple and inexpensive device could improve the quality of care we can provide while significantly reducing healthcare costs—for example, by more quickly moving patients off expensive drugs that are no longer effective.”
“We have partners across many industries, and human diagnostics is one of them,” Heller says. “We’ve had interest from pharma companies. With a device like this, we can more realistically and pragmatically send one home with clinical trial participants. We can detect presence of a drug. We can look for side effects, like protein in urine. We could potentially shave years off clinical trial times.” 

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