2022 Disruptive Technology Award Semifinalists

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

Co-Diagnostics, Inc. — YourTest PCR
Cytovale Inc. — IntelliSep
FloBio LLC — "Physio" System

More: View finalists


Co-Diagnostics LogoCo-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 LogoCytovale 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.

 

Flo Bio LogoFloBio 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.