Spotlight Interview With Viracor’s Steven Kleiboeker

 Viracor Eurofins Laboratories (Lee’s Summit, MO) is a specialty laboratory focused on infectious disease, immunology and allergy testing for immunocompromised and critical patients. Viracor is a 100% subsidiary of Eurofins Scientific (Luxembourg). Under the FDA’s Emergency Use Authorization Guidance, Viracor was one of the first private labs to introduce a laboratory-developed test (LDT) for Covid-19. Laboratory Economics recently spoke with Viracor’s Steven Kleiboeker, PhD, Vice President of Research and Development.

Describe the current status of Viracor’s Covid-19 testing?
We started Covid-19 testing on March 13 using our unique assay design which included EasyMag specimen nucleic acid extraction and Thermo’s ABI 7500 analyzer and reagents. Our initial capacity was 1,000 tests per day with turnaround time within 24 hours of specimen receipt. We quickly
ramped to 2,000+ tests per day with 2-3 day TAT. Our sister lab in Alabama, Diatherix Eurofins, is also performing Covid-19 testing with capacity of 2,000 – 3,000 tests per day.

A large percentage of those tests are processed within 24 hours. However, due to a small backlog, unprecedented demand, pressures on our supply chain, and shipping delays (some of which are related to specimen quality), our turnaround time for some clients has been pushed beyond what we normally experience. At most, we are looking at a 2-3 day TAT.

Ultimately, we expect to get turnaround times across-the-board back down below 24 hours, but right now, the greatest need is for increased testing capacity. Both labs are running 24/7 at full capacity and we still can’t meet the demand for testing. We have increased capacity by adding an additional platform (Abbott).

Are you encountering any supply shortages?
The supply chain is stretched and we’re doing all we can to stay half-a-step ahead. Specimen collection kits and swabs are a choke point. It’s hard to find the preferred universal transport media (UTM) collection kits, so we’re now looking at viral transport media (VTM) kits and phosphate buffered saline (PBS) as an alternative to keep specimen swabs moist during transport. Beyond swab and sputum samples, we are also exploring other specimen types.

Why did Viracor and Diatherix developed their own assays?
Instead of developing a single test, Viracor Eurofins and our sister lab, Eurofins Diatherix, leveraged our unique capabilities, techniques and equipment to develop a proprietary, molecular SARS-CoV-2 assay for Covid-19. This approach allowed each lab to go-to-market faster and because of the anticipated supply chain issues, it also allowed us to stratify risk across suppliers.

Diatherix uses a proprietary technology, TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) for precise detection of infectious diseases at high levels of sensitivity and specificity, and at very short turnaround times. It’s also a cost-effective way to multiplex several different respiratory pathogens.

If requested, the Diatherix assay for Covid-19 can be combined with other respiratory tests, producing results highly comparable to a standalone Covid-19 test.

Are you seeing prices rise for gloves, collection kits and swabs as a result of the shortages?
While there is pricing variability in this space, my impression is that prices have not increased with increased demand.

Where are your Covid-19 test orders coming from?
We provide reference testing services to approximately 200 academic medical centers and hospitals and that’s where the orders are coming from. We’ve added 10-20 new clients in the past few weeks. Hospitals are sending samples to wherever they can get the test result the fastest, whether that’s a state public health lab or private lab.

Are most Covid-19 tests being ordered in conjunction with a respiratory virus panel?
The combination of a Covid-19 test and respiratory virus panel and/or flu test is necessary because 4-7% of cases have co-infections (simultaneous infection by two or more viruses).
Are you working on an antibody test for Covid-19?
Another Eurofins lab subsidiary, Boston Heart Diagnostics (BHD), has developed a Covid-19 antibody test that was launched in early April. The blood-based antibody test identifies people who were exposed and developed an immunity to Covid-19, but potentially had mild to no symptoms. This test—unlike the NP swab which determines active infection—is a crucial next step in fighting the spread of Covid-19. Antibody testing should be done at least 14 days after exposure. Viracor will also soon be introducing a Covid-19 antibody test.

Given the overwhelming demand in acute care settings, the test will be initially offered to hospitals nationwide. As capacity increases, we will begin testing less acute patient populations, eventually allowing those with immunity to get out of quarantine and back to work.

Initial capacity will be nearly 5,000 tests per day, or 200 results every hour. Hospitals along the east coast, including those in hot-spot areas, will have the option to courier specimens to BHD for results in just hours. Speed is crucial to helping first responders and healthcare providers assess their ability to be on the front lines. Once Viracor’s antibody assay is launched, we expect daily capacity to increase.

Are other test volumes declining because people are staying home/less doctor visits?
Testing not related to Covid-19 has declined overall for a variety of reasons—people are staying home, not wanting to put themselves at risk by going to the hospital, etc. However, if you look at some of our most critical tests, like viral load testing, antiviral drug resistance testing, and immunology testing, the volume is mostly unchanged.

What precautions are you taking to protect lab employees from getting the virus?

It’s incredibly important that our lab scientists stay healthy. We have about 150 lab employees at Viracor and all non-essential lab personnel that can work from home are doing so. We’ve made it clear that any employee with symptoms should stay home and we’re taking the temperature of every employee before they enter the lab.

Do you see any similarities when compared to past outbreaks like Swine Flu, Zika or Ebola?
This really is unprecedented and will be a serious public health issue for at least the next few months, not weeks.

Could the warmer more humid weather in the spring/summer slowdown the spread of Covid-19?
Other respiratory viruses have been most problematic in the colder months when more people are together in enclosed rooms. The warmer months may bring some relief, but won’t be the savior.

What signs would tell you that the worst is over from Covid-19 in the United States?
If cases stabilize or decline, that would certainly be a good sign. However, it could be due to warmer weather, social distancing or some other unknown factor. However, if any of those known (or unknown) factors reverse, or others come into play, we could certainly see another period of increasing cases.