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Botanisol Analytics Performs Validation Process of Rapid Digital COVID-19 Screener with Leading Hospital

Botanisol Analytics Performs Validation Process of Rapid Digital COVID-19 Screener with Leading Hospital

Botanisol Analytics, a cutting-edge biological threat detection technology company, is performing, under a sponsored research agreement, a pre-clinical study with Beth Israel Deaconess Medical Center (BIDMC), an academic medical center affiliated with Harvard Medical School (HMS), that was designed to validate its rapid digital pathogen screening system for SARS-CoV-2, the coronavirus responsible for the COVID-19 pandemic.

A large scale pre-clinical study is currently being conducted at BIDMC, led by co-Primary Investigators Drs. Ioannis Vlachos and Stefan Riedel, faculty members of the BIDMC Department of Pathology. The study is moving towards its final stages and its outcomes will be used to support an application for FDA emergency use authorization (EUA) for Botanisol’s technology in order to make it available to national security and medical professionals across the country.

If validated, the technology could provide improvements over current testing options, including increased speed, portability, and automation. The portable system is designed to be carried by hand, operable by minimally-trained personnel, and provide an indication of infection risk for a large number of people in as little as five minutes subject to CFR 820.30 molecular testing and verification standards.The system’s capabilities can be extended by software to support a range of current and future threats.

Botanisol’s technology uses lasers to illuminate upper respiratory samples and interprets the optical signature associated with pathogens present in the sample. While current tests rely on a variety of reagents and other chemical consumables, Botanisol’s technology uses only a sample slide and can be used anywhere with a standard power outlet.
The existing COVID-19 detection systems are based on traditional molecular and antigen-detection based methods with varying turn-around-times (TAT) for results. Botanisol’s technology can lead to faster TATs. Current tests associated with rapid TATs have lesser sensitivity and specificity, whereas tests with higher sensitivity and specificity often require complex laboratory resources and have longer TATs. Botanisol’s screener does not require complex laboratory instrument-based analytical test methods, which enables results to be processed faster and at reduced cost.
Dr. Vlachos, the Co-Director of the Bioinformatics Program of the Cancer Research Institute, BIDMC and Assistant Professor of Pathology at Harvard Medical School, said about this project, “By adding cutting-edge Machine Learning technologies in the device’s software, our goals are not only to increase its detection accuracy, but also render it robust for deployment in diverse environments. Having access to high accuracy and low turnaround time screening approaches, especially in non-laboratory environments, could reduce time-of-response and spread of SARS-CoV-2.” Dr. Vlachos is also an Associate Member of the Broad Institute of MIT and Harvard and the Director of the Bioinformatics Unit of the Non-coding RNA Precision Diagnostics and Therapeutics Core, Harvard Medical School Initiative for RNA Medicine, BIDMC.
Dr. Stefan Riedel added, “Additionally, near-patient-testing and rapid, real-time diagnostic testing capabilities are needed to further support and enhance the current management response to the SARS-CoV-2 pandemic, and to limit the spread and decrease the threat of potential more widespread COVID-19 clusters and outbreaks.”
Dr. Riedel is the Associate Medical Director of the Clinical Microbiology Laboratories at BIDMC and holds an academic appointment as Associate Professor of Pathology at Harvard Medical School. Dr. Riedel’s clinical translational research laboratory has a long history of evaluating novel diagnostic methodologies for various infectious diseases. In addition, Dr. Riedel is also a member of various BIDMC/BILH leadership teams for managing the hospital’s and network’s laboratory response to the COVID-19 pandemic.
Botanisol CEO Dave Talenfeld said, “In order to get this technology to the people who need it as quickly as possible, we are developing it as a screening technology working towards an EUA and not a diagnostic. We’ve implemented a design control process and are working toward compliance with CFR 820.30 along with the EUA molecular verification and validation testing expectations.”
The validation program is supervised by Botanisol’s Dr. Ayse Ulgen, Director of Life Sciences Research. “We are thankful to our colleagues for the time and effort they spent studying and validating this technology and look forward to the EUA so we can make the device available for use by the broader medical community,” she commented. “It’s inspiring to work directly with some of the leading coronavirus researchers in the world. This breakthrough technology has the capacity to save countless lives.”
Botanisol CTO James Foley said, “We have brought together a great team, technology and vision. We continue our push to ‘illuminate the Unknown’ by improving, innovating and imaging a system that can provide meaningful information to decision makers quickly accurately and on the spot. Allowing for faster decisions to be made. The system’s software is designed for easy updates providing future capabilities to screen other pathogens according to FDA guidelines.”
Pandemic prevention is an essential component of national security, and the company has been awarded a contract with the US Air Force and it has an MOU with the Arizona Air National Guard. Once validated, Botanisol will be able to ship its systems to officials across the country to keep the nation’s armed forces, and the civilians they protect, safe. The research was approved by the BIDMC Institutional Review Board (IRB) and it underwent about six months of sample collection and processing. Botanisol aims to have its device approved under EUA by early 2021.
Botanisol Analytics’ work is supported by a grant from AFWERX and Air Force Ventures. This research was, in part, funded by the U.S. Government. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government.
About Botanisol
On a mission to “Illuminate the Unknown®,” Botanisol was founded in 2017 by David Talenfeld and James Foley to detect and quantify chemical compositions in seconds to determine the molecular makeup of substances instantly for screening of diseases, contaminants and intoxicants. Using next-generation Raman spectrometer technology, Botanisol’s small, portable device can be used in a variety of industries for inquiries ranging from disease or drug screening to chemical, biological and explosive threats. Botanisol is working with global partners in medicine, armed forces, agriculture, automotive, oil and gas and more to develop and test its technology. With Botanisol, you can get precise information to make critical decisions in an instant.

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