Research and Innovation Translation Partnerships in Point-of-Care Technologies

HemoSonics, LLC., Durham, North Carolina

• Quantra’s innovative clot detection technology uses ultrasound pulses to measure the development of a blood clot as it changes from a liquid to a solid.
• The Quantra system has been optimized for point-of-care with ease of operation and results interpretation—in approximately 15 minutes. Analysis occurs in a uniquely designed cartridge containing lyophilized reagents to measure various aspects of coagulation.
• Quantra has two commercially available cartridges: QPlus® for use in cardiac and major orthopedic surgery, and QStat® for use in trauma and liver transplantation surgery.

Armor Medical Inc., St. Louis, Missouri

• Maternal aRMOR is a wearable sensor device that healthcare providers can use to detect early hemorrhage in pregnant patients, and it enables timely treatment to improve maternal outcomes and minimizes healthcare costs.
• Maternal aRMOR provides clinicians with real-time, quantitative information about a patient’s hemodynamic state. The system monitors subtle changes in peripheral blood flow and alerts providers to a patient’s hemorrhage risk in real-time.
• Maternal aRMOR is the only continuous monitoring solution that detects early hemorrhage, even if blood loss is internal, regardless of skin color, delivery route, or spinal anesthesia status.

VPG Medical, Rochester, New York

• HealthKam AFib is a mobile health application compatible with both iOS and Android platforms that can help individuals with atrial fibrillation to manage their condition.
• The technology uses the mobile device camera to extract the pulse rate from the user's face passively during the time spent in front of the device
• It also uses advanced algorithms and machine learning to detect irregular heart rhythms indicative of AFib, providing users with instant notifications of potential AFib episodes, and empowers them to promptly seek medical attention.
• It is the only wearable-free solution for monitoring heart rate and for detecting abnormal cardiac rhythms associated with atrial fibrillation without the need for a dedicated device or any recording procedures.

Dionysus Digital Health, Inc., San Diego, California

• Dionysus is developing a platform of proprietary epigenetic tests to predict the risk of hormonal depressions, such as postpartum depression (PPD) and related mood disorders associated with PMS and menopause in women.
• Antenatal stress information from digital screening in conjunction with the epigenetic test can boost the technology’s overall predictive performance.
• This technology has the potential to introduce a shift in current clinical practice, by enabling early identification of at-risk women in a clear consistent manner to facilitate early intervention, better management, and improved outcomes.

BrainStem Biometrics, Palo Alto, California

• The BrainStem Biometric’s Monitor uses a sensor which is placed gently on the closed eyelid of the patient.  The non-invasive, lightweight and low-cost wearable sensor system detects ocular microtremors, nano-scale neurological impulse waves that emanate from deep inside the brainstem.
• The use of sedation in ICU patients is an important strategy used by clinicians to reduce pain and anxiety, facilitate treatment and improve patient outcomes. BrainStem Biometrics facilitates titration of drug(s) used for sedation.
• BrainStem Biometrics addresses the global problem of over-sedation in critical care by allowing clinicians to adjust medications to achieve target sedation levels.

NeuraStasis, Inc., Houston, Texas

• NeuraStasis' device for adjunctive care in acute ischemic stroke uses non-invasive, electrical neurostimulation as a bridge to care by preserving the brain, protecting patients from a lifetime of disability.
• The device delivers non-invasive pulsed transcutaneous electrical stimulation to the trigeminal and vagus nerves to preserve penumbral tissue within treatment windows. By coordinating the modulation of two nerves, this technology provides a novel cocktail therapy, combining downstream interruption of ischemic effects with collateral cerebral blood vessel augmentation.
• NeuraStasis would preserve at-risk brain tissue while a patient awaits endovascular thrombectomy.
• NeuraStasis is leveraging NIH and CINTA resources to complete safety testing prior to translating its novel technology to acute stroke patients.

Johns Hopkins University Plastic Surgery

• DPA713 is a clinical-stage investigational imaging agent that highlights macrophages in neuroinflammatory conditions.
• Macrophages invade nerves downstream from sites of nerve injury, where they remain until they are pushed out by regenerating axons (if regeneration occurs). Visualizing macrophage content along an injured nerve provides precise information on injury location, severity, and need for reconstruction.
• There is currently no reliable way to image the state of axons within nerves, leading to inaccurate diagnoses, delays in treatment, intraoperative uncertainty, and suboptimal care decisions.
• Intraoperative near infrared (NIR) imaging with DPA713 can provide POC diagnosis and characterization of nerve injuries.
• Improved identification of nerve injuries may lower healthcare costs by reducing operative times, preventing redo operations, and improving long-term function.

CITEC Center

• CITEC center hosts unique microfabrication capabilities. It has access to the first large-scale micro and nano additive manufacturing capabilities based on 2-photon polymerization using a Quantum X system from Nanoscribe.
• The instrument was the first 3D printer of this class built and provided to U.S. institutions and, possibly, one of only two currently available in country. It allows production of 3D printed parts at 120 nm feature resolution and 10-20 nm roughness within 50x50x25m3 volume. This enables the development of truly practical, repeatable and complex devices and components.
• The demonstration will provide a summary of micro/nano fabrication possibilities, including examples of fabricated components, some smaller ones viewed using a digital microscope.

Rice University, Houston, Texas

• High-risk human papillomavirus (HPV) DNA testing is widely acknowledged as the most sensitive cervical cancer screening method, but has limited availability in resource-limited settings, where the burden of cervical cancer is highest.
• HPV DNA tests have been developed for use in resource-limited settings, but they remain too costly for widespread use and require instruments that are often limited to centralized laboratories. To help meet the global need for low-cost cervical cancer screening, we developed a prototype, sample-to-answer, point-of-care test for HPV16 and HPV18 DNA.
• The test relies on isothermal DNA amplification and lateral flow detection, two technologies that reduce the need for complex instrumentation.

Rice University, Houston, Texas

• Cervical cancer remains a leading cause of cancer death among women in low-and middle-income countries. Globally, cervical cancer prevention programs are hampered by lack of resources, infrastructure, and personnel.
• We will demonstrate a multimodal mobile colposcope (MMC) designed to diagnose precancerous cervical lesions at the point-of-care without the need for biopsy. The MMC integrates two complementary imaging systems: 1) a commercially available colposcope and 2) a high speed, high-resolution, fiber-optic microendoscope (HRME).
• By combining these two image modalities, for the first time, location of suspicious cervical lesions can be identified- using the widefield imaging, and then coregistered high-resolution images across the entire lesion can be obtained.

Prompt Diagnostics, Baltimore, Maryland

• Prompt Diagnostics is developing a portable and affordable platform capable of producing lab-quality quantitative PCR results in under 30 minutes.
• The PCR platform includes a compact battery-powered instrument that transports magnetic beads in disposable plastic cartridges to automate nucleic acid concentration, purification, and PCR reactions. The simplified magnetic sample processing reduces the need for complex and expensive fluidics and flow controllers such that each test is constructed within a low-cost injection-molded housing the size of a USB drive.
• Results are analyzed and reported to the user by the instrument for streamlined workflow with minimal training. With integrated sample preparation we are building a plasma filtration module that will allow direct processing of fingerpick blood samples towards point-of-care HIV viral load quantification. In addition to blood plasma, on-board sample preparation allows a variety of sample types including swabs and urine for sexually transmitted infections and other infectious disease assays under development.

Baebies, Durham, North Carolina

• Baebies is building upon the success of our FDA-cleared diagnostic device, FINDER, to develop a rapid RTqPCR test for detection of HIV from whole blood samples. This platform utilizes Baebies’ patented digital microfluidic (DMF) technology that enables precise manipulation of reagents and samples without mechanical pumps or valves.
• FINDER enables the user to perform multiple assay types (molecular, immunoassay, hematology, chemistry, viscoelastic) on a variety of samples (plasma, whole blood, nasal samples, saliva, urine) without the need for sample preparation.
• The range of multifunctional assays available on a single platform is an industry-first and will provide clinicians with a more complete set of patient test results and consolidate diagnostic devices in the laboratory. With its user-friendly tablet interface and one step sample-to-answer workflow, operation of the FINDER platform is designed to be accessible to even minimally trained end users.

Azure Biotech, Inc., Houston, Texas, and mPOD, New York, New York

• Leveraging proven fluorescent lateral flow (FIA) technology in combination with a low-cost, proprietary ML-driven analyzer platform, SimplifiDx brings POC performance to at-home/OTC settings in a highly accessible, simplified one-step sample collection package, usable even by those with visual and dexterity impairments for less than $5/test.
• As a versatile platform, SimplifiDx strikes an effective balance between high performance and affordability, driving a paradigm shift in healthcare that was previously not possible. Optimized for at-home/OTC testing, catering to a broad range of potential test options within its menu including multiplex infectious disease, women’s health, cancer markers, and cardiac markers to name a few. 
• As a standalone platform, SimplifiDx puts patient privacy first by enabling streamlined digital result reporting via encoded results and associated data in a HIPAA-compliant HL7v2 format direct to web portals such as makemytestcount.org. This secure package can be re-transmitted via secure API to authorized personnel such as PCPs and health professionals for test-to-treat support patients or health authorities on state and federal levels to deploy appropriate health policies

Sapphiros, Boston, Massachusetts

• Sapphiros is developing a next-generation molecular test that can detect and distinguish between SARS-CoV-2, influenza A, influenza B, and RSV-A/B viral RNA from a single anterior nasal swab sample. The at-home user experience is designed to be simple with minimal steps and no off-board sample manipulation.
• The integrated battery obviates the need for wall power, thus ensuring the test can truly be used anywhere.
• Briefly, the user collects a nasal sample using the provided proprietary nasal swab and introduces the swab directly into the device. The user waits ~15-20 min at which time test results are displayed on the device. The user has the option to transfer test results to a smartphone app where they can securely communicate test results to their healthcare provider and transfer deidentified test results into a national database to enable surveillance.

Prominex, San Diego, California

• We have developed an ultrafast molecular diagnostic testing solution for infectious diseases that delivers lab-quality results in as little as 5 minutes at a cost comparable to that of rapid antigen tests. With our easy assay workflow, we can directly process crude clinical specimens, without sample preparation, simplifying and expediting time to result.
• Our approach combines a novel molecular nuclease-based amplification technology (dCliP) with the simplicity of a digital lateral flow detection technology. Our dCliP system is capable of simultaneously detecting the presence of  different infectious agents such as SARS-CoV-2 and Influenza for respiratory diseases and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) for STIs.
• Our reusable digital device is easy-to-use and eliminates user interpretation of results addressing current accessibility issues for individuals with disabilities.

Scout, Santa Clara, California

• Scout is a fast, accurate, and affordable molecular platform designed for at-home and point-of-care diagnostic testing. It uses a small, portable instrument, called Scout Hub; single-use diagnostic test kit; and the Scout Connect mobile app.
• The technology leverages a patented chemistry—loop-de-Loop RT-LAMP—to enable multiplexed detection of targets in a single tube with PCR sensitivity. This drastically reduces the cost and complexity of test kits and hubs.
• Additionally, Scout Connect can integrate with existing digital health and telehealth solutions, offering patients a convenient solution to test themselves and receive results and virtual care at home.

AccessBio, Somerset, New Jersey

• The CareSuperbTM COVID-19/Flu A&B/RSV Antigen Combo Test (OTC/POC) is a medical diagnostic tool that delivers high sensitivity, ease of use, rapid results, and affordability.
• Its lateral flow immunoassay technology enables the detection of SARS-CoV-2, influenza A, B, and RSV in 15-20 minutes.
• It could be especially useful during periods of potential triple threats, where multiple respiratory illnesses could reach their peaks concurrently.

Co-Diagnostics, Inc., Salt Lake City

• The Co-Dx™ PCR Home™ is an automated IVD test platform providing simultaneous, multiplexed, real-time PCR detection of as many as six targets in less than 30 minutes.
• Results are immediately available to patients, health care providers, and, if required, public health authorities. The system is comprised of a reusable instrument (the Co-Dx™ PCR Home™), a single-use test kit, and a mobile app.
• The inexpensive system ($300 instrument, $20 per test) is intended for use by anyone in just about any setting including at home or at the Point-of-Care (e.g. rapid care, pharmacies and other low resource settings).