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Cambridge scientists develop COVID-19 test

  • UMES doctoral student Rob Figliozzi has a hand in its development

    Friday, April 3, 2020
    Robert W. Figliozzi, a UMES doctoral candidate

    By Hannah Combs ~ The Star-Democrat

    Life as we know it changed early in 2020 across the United States, but here on the Eastern Shore two scientists had already developed a test that will be instrumental in predicting a patient's risk of advanced coronavirus disease and death.

    IES Life Sciences, Inc., a biotechnology company in Cambridge, Md., has developed the process for a test for COVID-19 that could provide confirmation of diagnosis and identify high mortality risk patients.

    For high-risk patients, COVID-19 evades and tricks the immune system into attacking lung tissues, leading to pneumonia and death without successful hospitalization.  The virus tricks the immune system through a "cytokine storm."

    While a test already exists to identify whether a patient has COVID-19, the technology created by IES has the ability not only to test pre-symptomatic individuals, but also measure the severity of the infection and the risk of experiencing a fatal cytokine storm - whether a mild case or requiring hospitalization - and see where that patient is on the bell curve, said David Spiegel, IES' chief executive officer and co-founder.

    "It is a very predictive test," Spiegel said. "No other tests measure (like this one) and it is the most effective test we have seen."

    For this specific test - although IES has the patent and is a for-profit company- "in a national emergency we just want to be able to cover our costs," Spiegel said.

    IES published a white paper in March about its test, outlining a proposal for collaboration in which IES requires clinical collaborators to supply blood specimens from confirmed COVID-19 infected patients to quickly develop a Coronavirus Interferon Disruption Test, or CVID.

    In layman's terms, it means running tests several times (over 12 months) throughout the infection to see how the immune system and clinical treatments succeed and fail against the infection.

    The lead scientist for this project is Robert W. Figliozzi, IES Life Sciences' research and development director.  Figliozzi, a University of Maryland Eastern Shore doctoral candidate in toxicology, has over eight years of experience in immunology and biosafety level-2 virology research and development.  He has been managing collaborative research between IES, UMES and the University System of Maryland for over two years.

    Ron Jubin, Ph.D., IES' chief science officer and co-founder, has 30 years of experience as a virologist developing several drugs and conducting novel research towards the patient's immune response to infection.

    EIS' initial target for test development was lupus, an autoimmune disease. Jubin became involved because of his sister's experience with lupus - and a frustration when doctors explained there was no definitive diagnostic test for the condition.

    "The company had a heartstring for lupus," Figliozzi said.  "We started looking at RSV (respiratory syncytial virus), allergies and influenza with the goal to develop a tool to identify lupus earlier than it is currently able to be diagnosed by … ruling out other disease processes."

    Jubin worked with the Federal Drug Administration to develop a test that measures interferons - immune system regulatory genes - through an FDA-approved assay that measures gene expression. The test was patented and IES has rights to use technology for commercial development.  The FDA gets to use patent for academic research.

    Early in the research and development phase, before COVID-19 became a pandemic, the IES team realized its test could identify contagious diseases immediately following exposure with a simple blood test.  In conjunction with EIS advisory board member Kenneth Dowd, a retired U.S. Army Maj. Gen., the company began looking at the implications its technology could have for national security and military applications.

    "In the event of an outbreak of a disease of unknown origin, the IES test can be deployed to quickly and reliably identify the source of the outbreak, accelerating response times and significantly aiding in containing and combatting the outbreak," Spiegel said.

    IES has been established in the Eastern Shore Innovation Center, which houses its corporate offices in Cambridge.

    "It is a very friendly, social place," Spiegel said, "and the staff there makes our lives easier in the business world. We absolutely love it."

    The decision to locate in Dorchester County was in large part due to the availability of a Maryland tax credit program that allows investors a 75% tax credit on their investment, Spiegel said.  Funding is critical to IES moving forward with this testing for COVID-19.

    With the assay, or test, developed by IES, results can show a body's immune system response to exposure within an hour.  But two holdbacks keeping development of the test for COVID-19 from moving forward more quickly is availability of blood samples and funding, Spiegel said.  The lab currently has enough supplies to conduct 50 to 100 tests, he said, but IESneeds funding to get more supplies to continue the process.  Human samples are in the range of $2,000 per sample, another significant expense.

    "I think we can do this, apply this test to COVID, the way this virus is presenting like this - a multi-system autoimmune attack - and potentially help guide application immune-modulating pharmaceuticals," Figliozzi said.

    Figliozzi recognized similarities between the way COVID-19 was tricking the immune system into attacking itself and the way autoimmune diseases like lupus result from scrambled immune signaling.  Figliozzi said he believes autoimmune disease medicines might help protect against advanced COVID-19 disease and mortality.

    The biggest hurdle, Figliozzi said, is getting patient samples, which must be obtained through strict, approved protocols, and - with liability issues to consider with human research - comes at a big expense.

    "Our test would be pretty easy to implement and the sample we need is the same one they are collecting anyway; the actual sample is very small," Figliozzi said.

    "We can help the pharmaceutical companies," Spiegel said.  "In the pharmaceutical world it is not the big guys who are leading in innovation, it's smaller companies and researchers."

    Speeding up the process and making the test available to providers could be key in how (quickly) COVID-19 is handled.

    "We really want to get this white paper in front of the right people," Figliozzi said.

    There is more sharing of information in research now than ever, he said. "I am feeling very confident that we will see something with our assay.

    "The test, when used on this virus, makes sense because COVID-19 (SARS-2) has evolved to evade and suppress our immune system and this is what our test measures," Figliozzi said.

    "With the test, we should be able to measure if your body is able to handle the virus and if you have it, what the response will likely be, and maybe alleviate some of the fear of the virus by measuring the way it scrambles the communication of our immune system and identify medicines that can restore healthy immune communication reacts," Figliozzi said.

    This article is reproduced here with permission of the Easton (Md.) Star-Democrat newspaper (APG Media of Chesapeake),a more-detailed version of which was published April 1 online.