CEO SUMMARY: Physicians treating patients with compromised immune systems who contract the new coronavirus need immunology tests to guide risk-assessment decisions for these patients. At a Virginia lab that specializes in such testing, specimen volume has tripled since the SARS-CoV-2 pandemic began. The lab does immunology testing for patients needing transplants, as well as for patients who have AIDS, cancer, diabetes, heart disease, and certain genetic disorders.
SINCE THE START OF THE NOVEL CORONAVIRUS PANDEMIC, a small immunology lab in Fairfax, Va., that tests patients with compromised immune systems has seen its test volume soar by about 300%.
The increased demand for testing led Oral Alpan, MD, founder and Lab Director of Amerimmune, a private diagnostic immunology flow cytometry in-office lab, to add three members to the lab team. Founded in 2011 with two employees, Amerimmune now has eight staff members caring for COVID patients.
Targeting High-Risk Patients
For any clinical lab, adding immunology testing could be a winning strategy for physicians treating patients who have the COVID-19 illness. These doctors need to identify patients who have compromised immune systems from a known or unknown deficiency or illness that could place these patients in a high-risk category for serious disease, Alpan said.
“With the onset of the pandemic there has been an increasing demand to work up COVID patients immunologically in addition to identifying those who are at risk for serious disease,” said Alpan, an allergist and clinical immunologist who is also the Director of the clinic’s immunopathogenesis section.
More Lab Test Referrals
In an interview with The Dark Report, Alpan stated that lab test referrals rose significantly due to demand from physicians and hospitals caring for patients diagnosed with the COVID-19 illness, both locally and from cities and states— such as New York—where the rate of infections and hospitalizations were high.
“This increased demand for testing came because of the need for complex flow cytometry assays that are validated to be used in clinical settings,” noted Alpan, who is an Associate Professor of Pediatrics at the Virginia Commonwealth University Inova Campus in Falls Church.
“The demand for these specialized assays put Amerimmune in a unique position to do the work-up on these patients,” he added. The laboratory normally runs about 300 tests each month. “Patients who have compromised immune systems may have AIDS, cancer, diabetes, heart disease, some genetic disorders, or be obese or malnourished,” he explained. “Also, certain treatments can suppress the immune system, such as anticancer drugs, radiation therapy, or treatment with stem cells or in preparation for an organ transplant. All of those patients would be immunosuppressed.”
From Fellow to Entrepreneur
Board-certified in allergy and immunology, Alpan had a fellowship early in his career in allergy and immunology at the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. At NIH, he worked with Anthony S. Fauci, MD, the Director of the NIAID and a member of President Trump’s Coronavirus Task Force.
Seeing a need for immunology testing, Alpan founded Amerimmune in 2011. “Our initial requests for testing came from a wide variety of doctors who were taking care of transplant patients with possible immune disorders,” he said. Now, many of those same physicians are caring for hospitalized COVID patients and are using Amerimmune’s flow cytometry tests to determine how the virus attacks patients’ immune systems.
“At this time, for example, there is no literature on how the COVID infection affects transplant patients,” continued Alpan. “Yet, it’s critical for physicians taking care of these patients to understand how COVID affects transplant patients’ immune systems. Once they know that, they can prescribe the medications their patients need.
“Almost all flow cytometry tests are classified as laboratory-developed tests (LDTs), and we plan to submit for FDA review certain of our LDTs that have predictive value in response to drugs or would be diagnostic for certain disease states,” he added.
“When the pandemic started, we saw an opportunity to help COVID patients because their immune systems are compromised,” Alpan noted. “Physicians want to understand how their patients’ immune systems are suppressed. We also realized that we could help not only physicians and their patients, but also society and the business as well.
“For several years, we’ve worked with the Medstar Georgetown Transplant Institute in Washington D.C. because those patients who need transplants are on immunosuppressants,” he said. “We also have collaborated with the State University of New York (SUNY) Downstate Health Sciences University Division of Transplantation in Brooklyn.
“Since the start of the pandemic, we’ve done testing for physicians treating patients in the transplant institute and for physicians at SUNY Downstate who are referring testing to us for their patients,” Alpan reported. “Our tests help to identify the immunophenotype in those patients to understand what the COVID-19 disease is doing to them.
“Any patient with the coronavirus is vulnerable, but those with a compromised immune system are among the most vulnerable of COVID patients,” he said. “For these patients, we do flow immunophenotyping and may also run some of the traditional standard flow cytometry assays.”
Amerimmune also works with its referring physicians to develop novel assays to identify the specific clinical needs of coronavirus patients. As a principal investigator in immunology, asthma, and allergic disorders, Alpan has published articles and abstracts in peer-reviewed journals.
“Since the end of March, we’ve developed and validated about 10 new assays for this population, so that we could offer these tests for clinical purposes,” he explained. To understand how to treat these patients, Alpan and his colleagues reviewed the research published about treating HIV patients and applied what physicians treating those patients learned.
“These tests are not available in kits that a lab can buy,” Alpan commented. “That’s why we read the clinical literature to understand what kinds of tests would work for these patients. From there, we perform assay development in a clinically relevant way. Once we determine that an assay works, then we validate it.”
The Role of Immunodeficiency
In the immune system, no single cell is responsible for immunodeficiency, explained Alpan. “Some people are compromised in different parts of their immune systems,” he commented. “If a patient’s antibody-producing B-cells are immunocompromised, that patient may not be a good candidate to respond to a coronavirus vaccine,” he said. “Or, if a patient has a problem with NK-cells—which are the initial defense against viruses—he or she may not do well during the acute phase of a viral infection. Those with T-cell problems are probably at the highest risk for severe disease.
“First, we need to understand what parts of the immune system are affected,” he added. “When we know that, we have a different thought process about how to care for that patient moving forward.
From Bench to Bedside
“We also have to understand how a patient’s immune system works as a whole, and we can do that by analyzing the data wholistically,” he said. Amerimmune’s client physicians were already familiar with Alpan’s work. Thus, when the coronavirus started to spread, those physicians turned to Amerimmune to learn more about how the virus affected their immuno-compromised patients.
“That’s when we started getting calls from physicians who had used us in the past,” he explained. Some of those physicians were treating transplant patients and some had new positions in other practices but were treating high-risk patients whohad compromised immune systems.
“Certain patients are easy to identify, such as those who are obese, diabetic, or have heart disease,” Alpan commented. “Other patients might be compromised, but their conditions are invisible. For those patients, laboratory testing is required to define the condition.
“Patients are compromised if they have rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease,” added Alpan, the co-director of the clinic’s Eosinophilic Gastrointestinal Disorders unit. “But others are just people who don’t know they have problems.
“A person doesn’t need to have a long-standing problem to be immunodeficient,” he said. “Sometimes he or she could be immunocompromised and parts of their immune system make up for that deficiency. Then one day, the individual gets hit by a virus and that’s when things go south. This is often the case when you hear in the news that an otherwise healthy teenage boy got COVID and died.”
An Unusual View
From his position as an expert in the diagnosis of high-risk coronavirus patients, Alpan has an unusual view of the effect of the SARS-CoV-2 outbreak. “The COVID-19 pandemic has been tough on our communities, on the country, and on the world as a whole,” he commented. “For those of us in healthcare, it has brought different challenges. Physicians on the frontlines have been dealing with the dying and critically ill in a heartbreaking way.
“Others, such as those of us in diagnostic testing, are innovating by identifying new diagnostics and therapeutics,” he added. “That’s a real test for us: to deliver for the larger good after years of training and practice.
“The pandemic and the challenge to find cures and diagnostics will continue for months and perhaps longer. For laboratories like ours, it means there will continue to be challenges and moments to shine,” he concluded.
Contact Oral Alpan, MD, at 571-418-4824 or firstname.lastname@example.org.