New York and Rehovot, Israel-based in vitro diagnostics startup Todos Medical Ltd. is developing blood tests for the early detection of cancer and neurodegenerative diseases using Fourier-transform infrared (FTIR) spectroscopy. Now the company is looking to apply the technology in diagnosing infections, including the novel coronavirus, COVID-19.

The expectation that Todos Biochemical Infrared Analysis (TBIA) could be used to quickly identify COVID-19 cases is supported by a 2018 proof-of-concept study published in the journal Analytical Chemistry. Researchers at Ben Gurion University isolated white blood cells and plasma from peripheral blood samples patients with confirmed viral or bacterial infections and analyzed them via multivariate analysis – principal component analysis followed by linear discriminant analysis – to identify whether the infectious agent was viral or bacterial roughly one hour after the blood sample was collected. The results showed a sensitivity of 82% and specificity of 80%.

“With the recent explosion of novel coronavirus worldwide, definitively diagnosing viral infections versus bacterial or other types of infections that present with similar symptoms has become paramount in order to appropriately triage patients and guide treatment decisions for health care professionals,” said Gerald Commissiong, Todos’ president and CEO.

First up: a feasibility study

The company is currently assessing potential sites to conduct a feasibility study and hopes to move from there to a later-stage trial. Once the test is ready, commercial scale up should not be a problem, he told BioWorld, noting a commercial preparation study for Todos’ breast cancer test in underway in Romania, “and we have already begun preparing the analytical performance required to commercialize at scale.”

Considering the volume of testing COVID-19 could require and the likelihood such testing will become routine going forward, “we are thinking of positioning ourselves as the long-term solution due to our very low COGS [cost of goods sold], although it is possible that we could move very rapidly with the right partners, he said.

Founded in Rehovot in 2009 with technology licensed from Ben Gurion University, Todos is currently two tests for breast cancer – TM-B2 for women who have had an inconclusive mammogram and TM-B1, which could replace mammography altogether. The company is also developing a test for colon cancer and is in early development of tests for leukemia, prostate cancer and ovarian cancer.

The FTIR platform, on which all of the tests are performed, essentially works by shining a laser through blood and detecting different wavelengths that bounce back based on the immune activity it picks up.

Building an algorithm for COVID-19

“Because we are using spectroscopy to interrogate the immune system by looking at peripheral blood, our technology can allow for a ‘pan-test’ where one sample of blood identifies all of these cancers,” Commissiong said. “We are looking to expand that into viruses and would likely accelerate coronavirus testing,” he added, noting that could slow the development of some secondary cancer tests.

Before it can develop a COVID-19 test, the company first needs to identify a sufficient source of patient samples to train an algorithm and then further train it prospectively on suspected cases. “We only needed a few hundred samples for our cancer test, and so we think it would be similar for viruses,” Commissiong said.

To build its algorithms, the company uses multivariate analysis and adds artificial intelligence and machine learning on prospectively captured data from patient samples to tune them to identify various patterns that correlate strongly with specific disease targets.

Commissiong said Todos is finalizing its strategy and preparing to engage regulatory authorities to advance a COVID-19 test. Because countries generally frown on importing viruses via human samples, the company could be required to have laboratories in each country and is trying to identify the best countries with which to work. “We are obviously very interested in working with FDA,” he said.

Alzheimer’s also in the pipeline

In addition to its work with cancer and viruses, Todos is developing tests for neurodegenerative disorders. It’s first product is the Lympro Test for Alzheimer’s disease, which was initially developed by Thomas Arendt, head of the department of molecular and cellular mechanisms of degeneration at the University of Leipzig in Germany. “We believe Alzheimer’s is essentially cancer of nondividing cells, and that is why these technologies were combined into the same company,” Commissiong said.

New York-based Commissiong joined Todos as CEO in January and has been tasked, along with newly appointed CFO Daniel Hirsch, who is based in Israel, with overseeing the relocation of Todos to the U.S. Commissiong said he has been focused on bringing in capital and preparing the company to list on Nasdaq.

The relocation follows Todos’ January agreement to purchase Provista Diagnostics Inc., of Alpharetta, Ga., an in vitro diagnostic company with a CLIA/CAP-certified lab that is developing a blood test for breast cancer.

With an already busy pipeline and plans to pursue a quick blood test for COVID-19, Todos is looking to raise additional funds. Last week, the company reported that it has entered into convertible note extension agreements and lock-up agreements with certain institutional investors who participated in a $1.35 million bridge financing in early 2019. The company scooped up an additional $163,000 in 2020 bridge financing involving U.S. and Israeli-based investors.

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