Spotlight Series: The future of diagnosis

Renee Shenton
Oct 6, 2020 · 7 min read

This week, Breakout Labs is shining the light on Entopsis. One of our earliest funded companies, Entopsis develops a low-cost, versatile, nano-engineered platform for diagnosing multiple diseases from urine samples. The funding from Breakout Labs enabled the company to create the first versions of their platform technology. Since then, Entopsis has developed a prostate cancer test with its own CPT code, secured agreements for commercialization of four oncology tests in the US and created a product line that increases COVID-19 testing capacity. They are looking to close a round of funding by the end of the month. We sat down with Entopsis’ CEO Obdulio Piloto to learn more.

Breakout Labs (BOL): Obdulio, thanks for joining us. We funded Entopsis in 2012 — just the seventh company to join our portfolio in our very early days!

Obdulio: Yes! We had nothing: no lab, no equipment and no team. I remember my co-founder, Ian Cheong, reading about Breakout Labs and saying ‘There are these fun crazy folks that fund only crazy ideas,’ and I said ‘we fit the bill!’ So I contacted Breakout Labs via the website, submitted a proposal, and the rest is history.

BOL: That’s great! Can you tell us more about Entopsis?

Obdulio: Entopsis has created a cost-effective diagnostics platform for regular health monitoring. Our core platform, OpsisDx™, was developed to diagnose numerous diseases through the use of urine samples. This platform works by comparing an individual’s unique bio-molecular profile created through unbiased sampling of molecules present in the urine, to an AI-driven library of previously learned profiles of both diseased and healthy states. In other words, we match your set of molecules to a library of profiles associated with various medical conditions (e.g., cancers, infections, etc.).

The use of unbiased bio-molecular profiles exponentially increases flexibility and capacities compared to the use of traditional, pre-determined biomarkers. This flexibility allows the same platform to simultaneously provide health information for a diverse set of medical conditions, ranging from something as serious as cancer to something more like a treatable infection.

In contrast, traditional diagnostics utilizing pre-determined biomarkers (e.g., DNA biomarkers) are limited to only a specific disease state. OpsisDx™ will enable a shift from a model of ‘one test — one disease’ to a model where multiple disease states are investigated from a single test.

In the long term, we envision OpsisDx™ deployed as a tool available directly to consumers that helps to proactively identify health problems before symptoms ever arise. For example, first, a patient would order a test online. Then, they’d take their test to a local pharmacy. Lastly, they’d receive their results within a couple of hours, along with recommendations for future screening or subsequent treatment.

BOL: That’s a bold vision indeed. Have you tested your platform on actual patients?

Obdulio: Yes — to date, data from over 1500 patients has been collected and analyzed, expanding five cancer types — lung, colorectal, breast, liver and prostate — and hepatitis B viral infection. While we wait for our peer reviewed manuscript to be validated, preliminary analysis shows OpsisDx™ may offer significantly better sensitivities than the current market leader utilizing liquid biopsy technology (GRAIL) for the detection of early stage cancers.

BOL: Are your tests currently on the market?

Obdulio: Several OpsisDx™ tests are currently being commercialized in partnership with the Genetics Institute of America (GIA) and other companies. Entopsis seeks to make individual or panels of tests available to the public in partnership with established global firms with a robust base of clients. We take a decentralized approach which allows us to focus on scientific discovery and capitalizes on our partners strengths in production and distribution.

For example, one of our recent collaborations involves a test that would focus prostate cancer biopsies on a much more targeted set of patients. Currently, the primary option for diagnosing prostate cancer is a biopsy, yet two out of three biopsies turn out to be negative for prostate cancer. The procedure involves extracting tissue samples from a sensitive area and is very uncomfortable for the patient — a literal pain in the butt. In addition to the pain and often observed complications, the accuracy of such tests is low in the currently tested population.

Through our partnership with the GIA, and in collaboration with top urologists, we developed a simple, non-invasive test that determines whether a prostate biopsy is warranted for men with abnormal PSA or DRE exams, which will be deeply impactful to millions in the US and around the world.

BOL: Far too often, novel technologies fail to actually make an impact in the market. Why is that and how is Entopsis different?

Obdulio: Proving that the science works and can be scaled is only part of the solution. Even with a successful LDT (laboratory developed test), there are barriers to widespread adoption by physicians. In order for physicians to start using this prostate cancer test widely, a CPT code is needed. A CPT code allows physicians to bill insurance companies for the test and is critical for widespread adoption. A CPT code is understandably based on rigorous evaluation, especially for novel, non-traditional technologies. Doctors don’t want to bill for tests that don’t work, which is why a panel of physicians must vote on the appropriateness of any test seeking a CPT code.

We’re pleased to report that the American Medical Association recently granted our OpsisDx™-powered prostate cancer test its own CPT code enabling physicians to bill and get compensation from insurance companies when ordering this test.

BOL:
Are there other applications for your technology beyond disease profiling?

Obdulio: Yes, we are making some of the technologies behind OpsisDx™ available as reagents and tools for others to build on. For example, take our line of PCRopsis™ products.

Normally RNA or DNA is extracted from clinical samples for diagnostic testing. This extraction process involves multiple steps, devices, reagents and can take hours. PCRopsis™ technologies (e.g., Reagent RVD) allow diagnostic labs to bypass the extraction step and start testing in ~10 minutes, at a significantly lower price point and without requiring new equipment. Moreover, this faster and less expensive process does not compromise on test sensitivity, which is often accepted as an unavoidable result of faster technological advances.

Several commercial laboratories, like Madison Core Laboratories, have incorporated PCRopsis™ technologies into their workflow to save time and money, while providing fast and accurate results to clients. From a business perspective, PCRopsis™ technologies have a quicker path to market, which provides immediate revenue while we proceed with commercializing OpsisDx™-driven laboratory developed tests.

These products are redefining how PCR testing is performed.

BOL: More efficient testing sounds like just what we need during a pandemic!

Obdulio:
Definitely. As you may have heard, extraction related materials have often been in short supply during the COVID-19 pandemic, which resulted in abnormally long wait times for results. This further exacerbated the fear and uncertainty during the height of the pandemic. These PCRopsis™ technologies are alternatives to RNA / DNA extraction for many PCR applications, including those to detect COVID-19.

Given the need, we finished the development of PCRopsis™ technologies on a compressed time frame, signed key distribution agreements and secured early customers.

We also submitted two SBIR grants and one project proposal to an undisclosed partner for the use of OpsisDx™ to detect COVID-19 infection through urine or cheek swabs.

Given its ability to simultaneously screen for multiple medical conditions, our platform could also serve as a pandemic early warning system for future biological, chemical and/or radiological events.

BOL: You’ve accomplished a lot recently! What’s next for Entopsis?

Obdulio: The next six months will be an exciting time for our team. Our peer-reviewed manuscript, providing mechanistic and clinical validation on OpsisDx™, is in review for publication. We expect at least one of three submitted grants to be funded, opening new R&D and commercialization opportunities. We also expect to see at least one OpsisDx™ test commercially available in the U.S. in this timeframe; providing market validation.

Our investment needs are minimal as we’re able to advance our efforts through non-dilutive funding. We anticipate being cash flow positive in Q1 2021. We are currently raising a $3M round, and a portion will be set-aside for the development of new diagnostic partnerships. These funds will be used to expand and commercialize internal technologies.

We also want to engage with others. If you have a passion for empowering consumers to have more information and control over their own health outcomes and a passion for commercializing novel technologies reach out to us at info@entopsis.com. We promise not to use so many acronyms in our first conversation.

Breakout Labs

Fund within the Thiel Foundation that supports early stage…

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