Background
Biological fluids from human body presents clues and hunches for disease diagnosis. Healthcare professionals rely on those clues to determine disease state and treatment course.
Blood tests are commonly ordered by doctors to check for diseases, conditions, organ functions and treatment progress. More recently, cell-free nucleic acids were found to circulate in blood. The cell-free nucleic acids in blood represent a sampling of genetic imprint of whole body. Genetic alterations and abnormalities can be detected in blood, albeit rare amongst a large majority of normal nucleic acids.
With recent advancement in DNA sequencing technology, massive parallel sequencing can be applied to identify small genetic changes from a large pool of nucleic acid sequences. Genetic mutations or abnormalities resulting in cancer, trace amount of infectious agents can be readily detected in blood.
Fetal genetic abnormalities can be identified with maternal blood. The field of “Liquid biopsies” was born and is the next frontier in diagnostic technology.
With the onset of COVID-19 crisis, the population wide diagnostic testing with various biological sampling became paramount. AerosolEaseTM provides hands-free sampling of aerosol from respiration or breath for infectious pathogens detection.
Almost all biological sample collections require hands-on and instruments, pre-analytical variations are introduced as the result. Pre-analytical variations influence on quality of laboratory tests.
Our Advantage
HunchDx is a technology-based startup company backed by a strong intellectual property protection position. We bring innovations to procure cell-free nucleic acids from biofluids.
Genetic alterations found from cell-free nucleic acids in biofluids is extremely rare. Identify genetic changes in a large pool of normal nucleic acids sequences is like finding a needle in a haystack; it requires high sensitivity and specificity. Current approaches are cumbersome, costly and time-consuming. Furthermore, pre-analytical sample variations is one key pain point in standardizing cell-free DNA (cfDNA) based liquid biopsy tests, it is the major hinderance on comparability of test results cross technology platforms. HunchDx is developing a suite of products designed to improve the sensitivity and standardization of liquid biopsy-based diagnostics.
The company’s first product PlasmaEaseTM is a patent pending blood collection device that procures plasma at the point of collection without the use of instruments or handling.
The product has passed the preliminary proof-of-concept laboratory tests and is at prototype design and clinical testing stage. The company is planning to launch PlasmaEaseTM by late 2021.
HunchDx's second product cfDNARefTM is a reference standard that truly mimics the cfDNA in plasma for tracking a liquid biopsy sample processing efficiency. cfDNARefTM is at the production refinement stage and a launch is expected for mid 2021.
The third product, DNAEaseTM is a fully-contained and automated plasma DNA extraction device, is at the design stage and expected to be introduced near the end of 2021.
HunchDx is in the process of developing AerosolEaseTM, UrineEaseTM, SputumEaseTM for collecting aerosol, urine, sputum samples, respectively. All sample collections are instrument-free, handling-free and standardizable.
AerosolEaseTM, a wearable respiratory bioaerosol sampling device to assess infections of the respiratory tract. The device is designed such that bioaerosol from nasal exhalations and/or breathes pass through a collection media to capture infectious agents, on-device infectious pathogens detection and identification enabling for at-home or point-of-care testing (POCT). The bioaerosol monitoring assesses an individual’s pathogen load and viral transmitting potential. Ultrasensitive IETHD technology allows on-device readouts. In connection with a web-based application software, the system not only empowers individuals to avoid further transmission of pathogens in the public and seeking appropriate health care; but also enabling public health professionals to predict outbreaks through early warning.
AerosolEaseTM is unique:
- Most products on the market are sampling by swabs. AerosolEase samples aerosol from breath or respiration. The sampling process is hands-free, less error-prone, less variations with high sensitivity for early infection detection.
- AerosolEaseTM is immunological based device for simple on device readout, not volatile organic compound (VOC) based requires instrumentation and machine learning.
- The device is enabled to detecting most known airway infectious pathogens on one device for early warning of pandemic or epidemic potential infectious pathogens. The device is not targeting at one infectious agent such as SARS-CoV-2. The device can be formatted to detect SARS-CoV-2 variants as well.
- IETHD technology enable much higher sensitivity and accuracy in detection of infectious pathogens than the conventional lateral flow immunological methods.
- The same product scheme can also be used to develop strategy in monitoring animal health and biological warfare.