2022 Disruptive Technology Award Semifinalists

Learn about this year's semifinalists and their disruptive technologies:

Biological Dynamics, Inc. — Verita Isolation Platform
Co-Diagnostics, Inc. — YourTest PCR
Cytovale Inc. — IntelliSep
FloBio LLC — "Physio" System
Nanopath — Nanopath Platform
Visby Medical — Visby Medical PCR Point-of-Care Tests

Biological Dynamics, Inc.

www.biologicaldynamics.com

Product/Technology

Verita Isolation Platform

Organization Description

Biological Dynamics, Inc. is a multiomics liquid biopsy company committed to improving global health outcomes by detecting disease at the earliest stages. Our proprietary Verita platform simplifies access to biomarkers, nanoparticles, and nucleic acids, enabling differentiated clinical applications. We apply this platform technology along with machine learning to detect cancers in blood and develop commercially viable assays for multi-cancer early detection. Located in San Diego’s biotech hub, Biological Dynamics operates a high-complexity CLIA and CAP-accredited lab with commercial-grade research testing services.

Our unique methodology enables isolation of biomarkers directly from high conductivity, biological solutions. The platform is based on lab-on-a-chip (semiconductor) technology, exploiting the principle of Alternating Current Electrokinetics (ACE). ACE causes preferential movement of particles within a specific size range when a sample flows across an energized array, and directly isolates cell-free molecular markers.

In late 2021, the FDA granted Breakthrough Device Designation for our Exo-PDAC liquid biopsy assay run on the Verita platform. The Exo-PDAC assay is designed to offer early detection for pancreatic ductal adenocarcinoma, one of the more aggressive and lethal cancers worldwide. We are working with the FDA on a path to commercialize our Exo-PDAC assay.

Our highly qualified board of directors, advisory board, and senior executives are guiding the company’s initiatives focused on giving clinicians the opportunity to intervene at the earliest stages of disease. Collectively, the team has 200+ years of experience and a track record of success in the semiconductor, communication technology, and healthcare sectors.

Product/Technology Summary

Our technology, backed by 51 patents, has the potential to change the way cancer is managed—not only when symptoms are present, but at earlier stages when the chance of survival is greater. Our breakthrough, novel methodology incorporates electrochemical engineering principles, not typically seen in biological applications, to isolate important biomolecules from blood to identify early signals of tumor presence. Our current study cohort is focused exclusively on clinical/pathological stage I and stage II cancers, as the chances of survival are greatly improved if tumors are detected early. Gaining access to informative biomarkers from blood can usher a new era of data for cancer detection that may be available to aid patients and reduce healthcare costs.

This synergy of medicine and biotechnology has the capacity to redefine non-invasive cancer screening and deliver transformative improvements to the whole healthcare ecosystem. We are working on producing a multi-cancer test to become the standard of routine medical care for everyone. Any time a patient visits their doctor for an annual screening (cholesterol or glucose testing, for example), one additional blood sample would be collected to screen for cancer. When our test becomes part of everyone’s screening process, many more cancers will be caught at earlier, more treatable stages. We envision a world where being diagnosed with cancer at stage III or stage IV is considered a rare event.

Co-Diagnostics, Inc.

codiagnostics.com

Product/Technology

YourTest PCR

Organization Description

Co-Diagnostics, Inc. (Nasdaq:CODX) is a Utah-based molecular diagnostics company that develops, manufactures, markets, and licenses state-of-the-art diagnostics solutions using its patented CoPrimer technology. The company’s mission is to provide robust, high quality PCR diagnostic tests at an affordable price, especially to regions of the world that wouldn't be able to afford them otherwise. The company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

Co-Diagnostics was one of the first U.S. companies to receive FDA EUA for its COVID-19 test at the beginning of the pandemic, and the first U.S.-based company to receive a CE marking for a COVID-19 test. Since then, the company has sold over 30 million tests to 189 domestic and 130 international laboratories. Co-Diagnostics recently acquired both Idaho Molecular, Inc. and Advanced Conceptions, Inc, the two companies collaborating on its upcoming at-home / point-of-care PCR platform. These companies are led by founders and leaders behind BioFire’s FilmArray, which is used worldwide for infectious disease testing. Per the terms of the agreements, Dr. Kirk Ririe and Dr. Carl Wittwer, both pioneers of rapid and real-time PCR who have launched a series of PCR instruments in use worldwide, and key personnel in the platform's development to date, are respectively serving as president of the wholly owned subsidiary and chairman of the company's Scientific Advisory Board.

Product/Technology Summary

YourTest PCR, the first device on the company’s new EIKON platform, is an at-home rapid test that detects SARS-CoV-2 RNA with high accuracy using real-time PCR in 30 minutes or less. The test uses a reusable compact hub and a single-use cartridge, for both single and multiple pathogen assays. The device is designed for use in a household or in a point-of-care setting by a person with minimal skills, with mobile app-guided instructions, and results reporting including video certification of results (such as for international travel). Raw data are analyzed by a secure cloud-connected software, results are displayed in the user’s mobile device, allowing optional transmission to the user’s electronic health records. The anonymized cumulative data can be shared for epidemiology and scientific studies, and for real-time geographical monitoring. In order to bring the full power of PCR (including qPCR, melting curve analysis, and multi-color multiplexing) to consumers and in particular to under-served communities, YourTest PCR uses cost-effective optics and components that allows wide accessibility at economics that are similar to the rapid antigen at-home tests for COVID-19.

The system is designed to be easy to use, inexpensive, and fast while maintaining the superior performance of PCR. The result is a low-cost, small-footprint platform that can be deployed widely in nearly every setting.

Cytovale Inc.

cytovale.com

Product/Technology

IntelliSep

Organization Description

Headquartered in San Francisco, CA, Cytovale is a dynamic, late-stage startup focused on developing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases, beginning with the early detection of sepsis. Cytovale’s technology is centered around host immune response and functions by evaluating the mechanical state of white blood cells, which allows the Cytovale system to provide accurate information independent of the pathogen. The company’s flagship technology, the IntelliSep test, can provide critical information related to a patient’s likelihood of having or developing sepsis (in the next 3 days) regardless of the source of infection: bacterial, viral (like COVID-19), or other sources (including those not previously identified). Using this technology, an early diagnosis for several fast-acting diseases can be achieved—resulting in early intervention, preserving valuable hospital resources, and ultimately saving lives.

Product/Technology Summary

Critical conditions commonly seen in the emergency department, like acute myocardial infarction (AMI), stroke, and sepsis, require rapid intervention to prevent morbidity and mortality. Emergent conditions like these demand emergent action: catheterization for AMI, TPA or surgery for stroke, and antibiotics with fluids for sepsis. For some critical conditions, there are rapid diagnostics to identify emergent cases (e.g. troponin for AMI, rapid-CT for stroke). However, there is no analogous rapid indicator for sepsis today. Like AMI and stroke, risk of sepsis-related morbidity and mortality can rise extremely quickly if untreated (up to 8% per hour of treatment delay), making rapid action essential. Unfortunately, clinical diagnosis of sepsis is challenging because many patients presenting with symptoms consistent with sepsis don’t actually have sepsis, leading to overuse of antibiotics (risking antimicrobial resistance) and waste of resources.

The IntelliSep test is a pioneering new way of quickly and accurately assessing the immune dysregulation that separates sepsis from less emergent infections or disease mimickers. This new and disruptive test simply and clearly determines risk of sepsis by directly interrogating over 30,000 white blood cells collected from a standard blood draw and analyzing these via a machine learning algorithm, generating easy to interpret results in under 10 minutes. This gives physicians actionable information when they need it most, allowing them to quickly and confidently triage suspected sepsis patients and prioritize those in greatest need. IntelliSep aims to help strained health systems optimize care, prevent unnecessary treatment, and improve compliance with SEP-1 guidelines, which affect reimbursement.

FloBio LLC

flobiollc.com

Product/Technology

FloBio's “Physio” System

Organization Description

FloBio LLC, formed in August 2017 as a spin-out of the University of Pennsylvania (UOP), is pioneering a novel microfluidic-based diagnostic platform technology that assesses bleeding and thrombotic risk at the point-of-care, with clinical applications being developed for emergency critical care patients. Although widely used in research labs, microfluidic devices have rarely been used at the point-of-care due to obstacles in manufacturing scale-up, and the technical expertise required.

FloBio is led by CEO Jerri Ann Thatcher, a life science executive with deep experience in commercialization, new product planning, and business development. The company was founded by Dr. Scott Diamond, the Arthur E. Humphrey Professor of Chemical and Biomolecular Engineering, an expert in microfluidics and blood testing technologies. Dr. Diamond was also the scientific founder of Reaction Biology Corp. More than 30 published, peer reviewed articles validate FloBio’s scientific approach and clinical utility across diverse clinical and pharmacological scenarios. FloBio has compiled a world class team, including diagnostic advisors, clinical collaborators, and experts in emergency critical care.

FloBio’s vision is to provide a near patient system that can be easily deployed in a variety of hospital settings to stratify risk, personalize treatment, and monitor patients, by providing an unprecedented level of clinically relevant and actionable outputs. The company continues to advance its diagnostic technology, benchmarking progress to date with a research use only system successfully used to demonstrate technical and clinical feasibility. FloBio resides at the state-of-the-art Pennovation Center in Philadelphia, Pennsylvania and is portfolio company of Penn Center for Innovation Ventures.

Product/Technology Summary

FloBio is developing an innovative functional hemostasis IVD for emergency critical care clinicians to rapidly uncover blood clotting abnormalities, with the goal of reducing complications and care expenses related to trauma, disease, or drug related coagulopathy or platelet dysfunction.

Abnormal blood clotting represents a major risk factor for emergency room patients and can lead to care complications. This is especially problematic in emergency trauma care, where decisions must be made in minutes to avoid severe bleeding complications, which increases healthcare costs, poor health outcomes, and can lead to death.
Existing testing approaches fail to adequately assess hemostasis, take too long for use in emergency care, or fail to identify the source of the problem, which provides indirect or incomplete results and often leads to empiric treatment and/or delayed decisions or care.

FloBio provides a solution to these challenges by providing real-time determination of a patient’s hemostasis state and anticoagulation in less than 10-15 minutes. The first product derived from our platform technology addresses the growing need to assess direct oral anticoagulants (DOACs) in emergency, critical care patients, detecting DOAC presence, class, and level. FloBio’s Physio system will comprise a tabletop analyzer, disposable test cartridge, and proprietary software. It is the first of its kind to combine hemodynamic flow and discrete activation to mimic and measure in vivo physiological blood clotting. Our game changing approach enables rapid cost-effective care decisions that will drive evidence-based blood product and costly DOAC reversal to avoid adverse bleeding and abnormal blood clotting.

Nanopath

www.nanopathdx.com

Product/Technology

Nanopath Platform

Organization Description

Nanopath is a molecular diagnostics company that aims to disrupt traditional testing methodologies. The company’s goal is to equitably improve the lives of patients, starting with women, by providing actionable molecular information within a single office visit. Nanopath was spun out of Dartmouth College in partnership with Dartmouth Hitchcock Medical Center. Nanopath’s co-founders, Dr. Amogha Tadimety and Dr. Alison Burklund, developed the primary components of the proposed platform during their PhD research at Dartmouth’s Engineering School. They were fellows in Dartmouth’s prestigious PhD Innovation Program, giving them access to courses at Dartmouth's Tuck School of Business and specialized training in technology translation. In the final stages of their PhD program, the founders came together to start the company. The two women are first-time founders. Nanopath closed a seed round of venture-backed financing in October 2020 and is currently raising its Series A. The company is currently based in Cambridge, MA at LabCentral—a launchpad for high-potential life sciences and biotech start-ups.

Product/Technology Summary

Nanopath has developed deep technological breakthroughs that have the potential to change the molecular diagnostic paradigm. Our proprietary solid-state biosensing platform utilizes ultrasensitive optical detection, which eliminates the need for nucleic acid amplification, and provides clinically actionable genetic information in less than fifteen minutes. We worked to strategically identify a beachhead market for Nanopath’s platform technology in the women’s health space. Existing tools for assessing women's health were not intentionally designed to meet the needs of the complex female biology or emerging healthcare models. Using our benchtop readout instrumentation and indication-specific test cartridges, Nanopath aims to capture specific and actionable information that reflects the nuance of the underlying biology within a single office visit. We envision Nanopath’s platform as the go-to system for routine women’s health screening at the point-of-care. To date, we have generated exceptional preliminary data in two clinical indications, human papillomavirus (HPV) genotyping and urinary tract infection (UTI) characterization. To expedite our FDA 510(k) de novo approval pathway, we are currently drafting a submission for an FDA Breakthrough Device Designation. Nanopath’s advanced technology enables high-complexity tests to be performed in-house, at the point of care. As a result, test revenue stays with the doctor and clinic, and aligns with emerging value-based care models. We believe that addressing the significant unmet need in the women’s health space will position us to tackle other enormous diagnostic markets, such as severe infection, liquid biopsy, and even the design of personalized diagnostic testing panels.

Visby Medical

www.visbymedical.com

Product/Technology

Visby Medical PCR Point-of-Care Tests (Sexual Health Click Test, COVID-19 Test)

Organization Description

Visby Medical is a diagnostics company that is transforming the order of diagnosis and treatment for infectious diseases. The company’s proprietary technology development program culminated in the world’s first instrument-free, single-use PCR platform that fits in the palm of your hand and rapidly tests for serious infections. Originally developed for sexually transmitted infections, the company’s FDA-cleared, CLIA-waived Sexual Health Click Test for women returns accurate results within 28 minutes. Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases. Visby Medical is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point-of-care, and eventually for use at home.

Product/Technology Summary

Visby Medical is leading the way in portable PCR with a tool that has the power to fundamentally change the treatment paradigm for patients and how physicians fight infectious diseases. Until now, there have been two choices in diagnostics: antigen tests that sacrifice performance for speed or the gold-standard for molecular testing, polymerase chain reaction (PCR) tests—which are highly accurate but typically have long turnaround times for results. The PCR process is extremely complex, and the equipment is typically three things: large, reliant on centralized lab expertise, and expensive.

The Visby diagnostic platform is the first of its kind: An all-in-one (instrument-free, no cartridges) PCR platform that delivers accurate results in under 30 minutes, during the patient’s visit with the clinician. Visby miniaturized PCR technology from room-sized to palm-sized dimensions, eliminating the need to send samples to remote central labs for processing. Patients face less anxiety receiving data-driven diagnosis and treatment during the same visit (which also encourages treatment adherence), while clinicians are empowered knowing they can provide the correct treatment. This versatile platform was first shown to detect DNA from pathogens that cause three of the most common, and curable, sexually transmitted infections (STIs) – chlamydia, gonorrhea, and trichomoniasis.

Because the device is small, portable, and disposable, the platform has the potential to benefit patients in remote areas who may not have access to high complexity labs. Since it is stable at room temperature, it’s highly suitable for use with deployed military forces or those in developing nations.