2022 Disruptive Technology Award Finalists

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

Biological Dynamics, Inc. — Verita Isolation Platform
Nanopath — Nanopath Platform
Visby Medical — Visby Medical PCR Point-of-Care Tests

More: View semifinalists


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.

 

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.