Bio-Stream Spectral Test

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THE PROJECT

Our team of experts from across the country is developing a new test for COVID-19: the Bio-Stream Spectral Test.

 

Our approach uses Raman spectroscopy and machine learning. We want your help to get it across the finish line and out to the world.

Stream.ML, BioMark Diagnostics, and a dedicated team of domain experts are collaborating to develop a novel test platform for the rapid detection of the SARS-CoV-2 virus. Using Raman and SERS, the Bio-Stream Spectral Test offers a comparable level of accuracy with the current PCR (polymerase chain reaction) “gold standard”. This Raman test is superior due to its minimal operator training, rapid data capture, inexpensive per-test cost (less than $1), and final results provided in less than 30 seconds.

This accelerated screening platform will include end-user software and configuring hardware into a commercial system that will be available for third-party testing of the SARS-CoV-2 virus. Our efforts are dedicated to improving the delivery, speed, and quality of healthcare to all, so we want to reach a wide audience to continue to gather support for this project. This collective effort will address an urgent and immediate need for accurate, ultra-rapid antibody diagnostic testing for SARS-CoV-2 that can contribute to the global health response.

Core Team

  • Rashid Ahmed Bux, President & CEO (BioMark Diagnostics Inc.)
  • Dr. Horacio Bach, Adjunct Professor (University of British Columbia, Division of Infectious Diseases)
  • Henry Langston, Chief Commercial Officer (Ocean Insight)
  • Dr. Mikolaj Raszek, CEO (Merogenomics)
  • Dr. Solange Gagnebin, Data Scientist (Stream.ML)
  • Dr. Trevor Allen, Spectroscopy Specialist (Stream. ML)
  • Dr. Lesley Esford, Virologist
  • Dr. Bram Ramjiawan, Director of Research Innovation and Regulatory Affairs (St. Boniface Hospital Research) & Adjunct Professor, Dept. of Pharmacology & Therapeutics (University of Manitoba)
  • Dr. Anne-Marie Dowgiallo, Senior Scientist (Ocean Insight)
  • Dr. Steve Buckley, Vice President: Product Development and Engineering (Ocean Insight)
  • Lee Marsh, CTO (Stream.ML)
  • Greg Gamble, Founder & President (Gamble Technologies Ltd.)
  • John Daugela, CEO (Pure Vertical)
  • John Murphy, CEO (Stream.ML)

As the world tries to return to the “new normal”, the short-term need is detecting the SARS-CoV-2 virus in hospitals and labs. Beyond this, we all will want to secure safe measures for interaction where social distancing (although necessary right now) proves to be an obstacle.

Airports, for example, may require individual passenger testing for each flight. A 30-second test would make this practical where current testing- set around 20 minutes per test- could be crippling.

Some essential apparatuses of our society that would benefit from rapid detection include military, protective services, and law enforcement. There’s also food packaging and assembly plants, plus eventually entertainment industries like sporting events, movie theatres, and music concerts. The possibilities are endless.

Through the Bio-Stream Spectral Test, our team offers the development of a detection tool that would screen populations to help overcome the barriers essential for keeping our lives moving forward. Furthermore, Raman and SERS is an emerging area of interest for bacterial and viral testing and so this effort will contribute to the state of the art in diagnostic technologies.

Our commercial product is to be the Bio-Stream Spectral Test. It is to be a portable, desktop size point-of-care SARS-CoV-2 screening tool that allows direct sample-to-instrument application, with the addition of antibodies to the sample being only for virus neutralization.

The scanned Raman spectral data is captured through surface-enhanced Raman spectroscopy (SERS) on an attached laptop. A simple API call sends the data to the Stream.ML machine learning model, and the predictive result is returned within seconds via the application software displaying the results on screen. With a push of a button, the Bio-Stream Spectral Test is to provide an instant spectral read on the sample which informs if the virus is present or not.

The goal is that this testing system will be just as sensitive as PCR (or better) and allow rapid detection without the need for extensive training for machine use. SERS will be customized for our application and is designed not only to increase the signal dramatically, but requires no time consuming sample preparation. It operates by a fast response mechanism with spectral acquisition, seldom requiring more than 30 seconds. The multi-environmental, multi-analyte capability of SERS makes it highly promising for  COVID-19 rapid screening application.

The primary applications would be in the hospitals receiving patients (removing the need for patient samples to be sent out to a laboratory) and markets where social distancing is a challenge. The Bio-Stream Spectral Test is to be accurate, reproducible, fast, accessible, and inexpensive.

1. We are already underway.

Basic tenants for antibody development for the virus are already in our possession: the access to a Level 3 Laboratory, access to live virus, access to an experienced team—  through Dr. Bach, Division of Infectious Diseases, Dept. of Medicine, University of British Columbia.

2. Detection has been a past success.

Implementation of a SERS system (showing Raman detection) has succeeded on virus in the past: a proven record of detection of cancer biomarkers at an ultra-low sensitivity range of 1 ng/mL using SERS, using a novel integrated Raman probe— through Rashid Ahmed Bux, Biomark Diagnostic Inc.

3. Vast experience in spectral data.

Years of experience collecting Raman data coming together with spectroscopy and machine learning being uniquely combined: custom neural nets that ensure optimal model performance can be created— through Stream.ML and Ocean Insight.

4. Wholesome kit is provided.

Our new test will be a turnkey testing system: complete with disposable sample-collection SERS substrates, a compact spectrometer, software, model execution, Raman hardware supplies, scanning instructions, and integration of the test data into electronic medical record systems. This, all to be also guided through Health Canada regulatory processes— through Stream.ML, Merogenomics, Gamble Technologies Inc, Clinisys, Pure Vertical, and St. Boniface Hospital Research Centre.

Advantages

  • Low-level virus detection
  • Low cost (including both consumables and analytics)
  • Viral strain specific identification
  • Rapid detection (machine learning models will return instant results)
  • Simplified sample handling processing for use in any health facility
  • Ability to be run by non-technical lab personnel
  • Does not need the same consumables as PCR
  • Can also act as a screening tool or additional verification for other tests
  • Same hardware can be used for many other elements (just need new machine learning models)
  • Can be set up in regions with limited infrastructure
  • Can be set up and running in minutes
  • Can transmit wireless data to a centralized health institution/monitoring system

Along with our strong team of experts, we are working with others to ensure a better outcome for all. Time is of the essence, so please reach out to us… especially if you are:

  • an experienced investor who understands the balance between a worthy project and healthy return on investment
  • a business owner where social distancing is a challenge in your company
  • working in a medical screening environment and would consider being a testing site
  • working a health facility that could benefit from a rapid test
  • able to mobilize a portable field system for rapid testing
  • a person with access to operating a Level 2 Lab interested in PCR comparison testing
  • working in a research facility that possess viral Raman spectra that we could process
  • a provider of health services in a developing country or marginalized community with limited infrastructure
  • working on a vaccine where a rapid test could support an effective rollout
  • selling, supporting, manufacturing Raman technology
  • doing research where this Raman approach could help speed up your project
  • interested in spreading the word about our project through personal network

TERMS & DEFINITIONS

Antibodies – proteins produced by the immune system in response to exposure to antigens. Each antibody contains a paratope which recognizes a specific epitope on an antigen, acting like a lock and key binding mechanism.  This binding helps to eliminate antigens from the body, either by direct neutralization or by ‘tagging’ for other arms of the immune system.

Nasopharyngeal swab – a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat.

PCR – Polymerase chain reaction is a laboratory technique used to detect the presence or absence of certain genomic fragments (DNA). PCR is very precise but time consuming and can be used to amplify, or copy, a specific DNA target from a mixture of DNA molecules. PCR is extensively used in analysing clinical specimens for the presence of infectious agents, including HIV, hepatitis, human malaria and anthrax.

Raman – a spectroscopic technique typically used to determine vibrational modes of molecules (signals) that is commonly used in chemistry to provide a structural fingerprint by which molecules can be identified.

SERS – Surface-enhanced Raman spectroscopy or surface-enhanced Raman scattering (SERS) is a surface-sensitive technique that enhances Raman signal.

More on SERS…

  • SERS has emerged as a powerful analytical tool that extends the possibilities of vibrational spectroscopy to solve a vast array of chemical and biochemical problems
  • SERS is an extension of standard Raman spectroscopy, a vibrational spectroscopic technique that provides high structural information content and one that has been used in biochemistry and life sciences.
  • SERS differs from standard Raman scattering in that the incoming laser beam interacts with the oscillations of plasmonic electrons in metallic nanostructures to enhance, by up to 14 orders of magnitude, the vibrational spectra of molecules adsorbed to the surface.
  • SERS provides ultrasensitive detection limits, even approaching single molecule sensitivity. Since Raman spectroscopy probes the various vibrational and rotational modes of a molecule, it is ideal for differentiating similar molecules with different functional groups.
  • Additionally, Raman spectroscopy is ideally suited for biological samples due to its inherent insensitivity to aqueous interference, unlike infrared spectroscopies. This detection strategy is more economical than the currently used LC/MS approach, and enables development of an easy-to-use point-of-care tool that should provide more rapid turnaround to the health care provider.

THE COMPANIES

Stream.ML

Stream.ML is a team of business leaders, developers, and scientists that bring together the power of reflected light and machine learning to make detection quick, easy, and accessible. They value high-quality products and an open, collaborative relationship with our partners to develop world-changing solutions.

https://stream.ml/   

BioMark Diagnostics Inc.

BioMark Diagnostics Inc. is a team of scientists, engineers, and medical professionals that produce innovative technology that increases prediction and accuracy in the diagnosis of cancers by incorporating the highest scientific standards. Their studies focus on the pivotal role that metabolomics plays in early cancer detection.

https://www.biomarkdiagnostics.com/   

Ocean Insight

Ocean Insight is the Applied Spectral Knowledge company. With 250 people in Florida, 8 locations around the world, over 250,000 spectrometers and systems delivering insight, for more than 25 years… they have discovered, refined and delivered new approaches to solving problems with spectroscopy and imaging technologies. Ocean Insight uses spectral technology, application expertise, and manufacturing scalability to help customers take on important challenges for a safer, cleaner, healthier future. We collaborate with science, research and industry customers to achieve ambitious goals, leveraging the power of light for advancements in health, safety and the environment.

https://www.oceaninsight.com/   

University of British Columbia

The University of British Columbia is a global centre for teaching, learning and research, consistently ranked among the top 20 public universities in the world and recently recognized as North America’s most international university. The Division of Infectious Diseases in the UBC Department of Medicine is actively involved in combating infectious diseases through patient care, education, and research.

https://www.ubc.ca/   

Gamble Technologies

Gamble Technologies is a closely held Canadian Corporation providing instrument solutions in the scientific, engineering and medical research communities as well as to the Canadian homeland security sector. They have the ability to reach resources that challenge single solution suppliers.

http://www.gtl.ca/   

Merogenomics

Merogenomics was conceived to make the benefits of genome sequencing more accessible. They promote awareness about the best societal use and economic value of genomic technologies among governmental agencies, policy makers, industry stakeholders, patient advocacy groups, and commercial interests.

https://merogenomics.ca/   

Clinisys

Clinisys is a software and analytics company offering a variety of secure, scalable, and user-friendly e-Healthcare solutions and data services to the healthcare industry. The company is comprised of a dedicated team of professionals from various disciplines including healthcare, IT, and business, united with one goal: to develop the next generation of Clinical Intelligence.

http://clinisys.ca/   

ARTICLES OF INTEREST

BioMark’s SERS technology

2015. Chimenti, J. Elliott, R.A. Bux, “Raman Spectroscopy Could Facilitate Deployment of Amantadine-Based Cancer Screening Technology— Enabling the Transition from Labs to Villages,” American Pharmaceutical Review, online, 2015.

https://www.americanpharmaceuticalreview.com/Featured-Articles/172809-Raman-Spectroscopy-Could-Facilitate-Deployment-of-Amantadine-Based-Cancer-Screening-Technology-Enabling-the-Transition-from-Labs-to-Villages/ 

SCIENTIFIC PAPERS

Detection of viruses using Raman spectroscopy

2019. Tong, C. Chen, J. Zhang, et al., “Application of Raman spectroscopy in the detection of hepatitis B virus infection”, Photodiagnosis Photodyn Ther 28(5):248, 2019.

https://www.sciencedirect.com/science/article/abs/pii/S1572100019302145   

2008. Shanmukh, L. Jones, Y.-P. Zhao, et al., “Identification and classification of respiratory syncytial virus (RSV) strains by surface-enhanced Raman spectroscopy and multivariate statistical techniques,” Anal Bioanal Chem 390(6):1551, 2008.

https://link.springer.com/article/10.1007/s00216-008-1851-0   

V.I. Kukushkin, N.M. Ivanov, A.A. Novoseltseva, et al., “Highly sensitive detection of influenza virus with SERS aptasensor,”PLoS ONE 14(4):e0216247, 2019

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0216247