Endemic COVID-19 Needs Novel, Prognostic Tests to Predict Severity and Progression

Coronavirus

COVID-19 has evolved into a long-term population health problem that requires new types of diagnostics. Diagnostic developers, therefore, are called on to expand their developmental focus to include novel tests to predict severity and disease progression as COVID-19 transitions from a public health crisis to a manageable, endemic disease.

“Last year, when the pandemic began, the goal was to check the spread of the virus. That means identifying who currently had the virus, who had it previously (and perhaps never knew it), who may be immune, and the transmission vectors,” David Parker, Ph.D., SVP, diagnostic solutions at Precision for Medicine, told BioSpace.

Nearly 300 FDA-authorized diagnostic tests are available now, but virtually all of them focus on those public health aspects of COVID-19, either detecting the presence of the virus or its antibodies.

“We still need those types of diagnostics, but we also need new, inexpensive versions that can deliver lab-quality results rapidly, at the point of care,” Parker said.

Now some diagnostic developers are looking ahead to the time when COVID-19 is endemic throughout the population and most people are vaccinated. From a public health perspective, COVID-19 will be treated like the seasonal flu.

“At that point, people will contract a respiratory disease and health care professionals will then need to manage the case differently, depending on whether the cause is COVID-19, the flu, pneumonia, or some other cause,” Parker said. “A different type of diagnostic is needed to address the disease implications.”

Diagnostics will need to determine, for instance, “who will have severe disease, which patients will require which types of treatments based on their severity, and who is most likely to respond to particular treatments.”

For example, after a diagnosis, a physician may want to use a prognostic test to determine the probable severity of the disease. Currently, such a test would merely alert health care professionals to watch more closely for worsening symptoms. In the near future, however, it may be possible to use such tests to match therapies to patients and to select antibody cocktails matched to a patient’s viral variants.

“Ultimately, we may want to look at biomarkers for COVID-19,” Parker said, explaining that elevated levels of certain cytokines or circulating immune response cells (like interleukin 6 or T cells with certain surface markers, respectively) may predict whether a patient will have cardiovascular issues, become a long-hauler, or have other serious responses.

Inflammatix is one of a handful of companies exploring the idea of a biomarker test. “It was working on a test to distinguish viral from bacterial infections – flu versus pneumonia, for example – and realized their biomarkers could be adapted for COVID-19 infection,” Parker said.

Its CoVerity™ test uses mRNA biomarkers to predict the risk of severe respiratory failure in COVID-19 patients and thus help physicians make better treatment decisions. The test does not measure the virus or antibodies in a sample, he pointed out.

Other companies and institutions also are developing predictive tests. For example:

  • MeMed Ltd., in Israel, is developing a predictive COVID-19 severity and progression test using continuous measurements of interferon gamma induced protein 10 (IP-10), a biomarker associated with inflammatory and immune diseases and immune system dysfunction.
  • Yale University’s SalivaDirect test shows that the viral load in saliva accurately predicts which patients are likely to develop a severe form of the disease, be hospitalized, or die. Rather than a kit, SalivaDirect is a protocol for CLIA-certified labs.
  • Researchers from Brigham and Women’s Hospital and a separate team from the Hospital Universitario Santa Lucía in Cartagena, Spain, each found that, among COVID-19 patients in the ICU, a test for C-reactive protein (CRP) predicted the need for mechanical ventilation.

The foreknowledge provided from such tests “would help physicians manage the infection before patients get really sick,” Parker said.

Not surprisingly, many of these new diagnostics are being developed by organizations with adjacencies, such as inflammatory or immuno-marker assays, that can be extended into the COVID-19 space. “Only a subset of companies are looking at entirely new assays intended for COVID-19,” Parker said.

Throughout 2021, the largest diagnostic developers are likely to concentrate on keeping the tests that were granted emergency use authorizations (EUAs) in the market and developing them as long-term products, he predicted. “They’ll focus on converting EUAs to 510k clearances.”

The smaller companies that established a toehold in the market during the pandemic will be loath to relinquish that revenue stream as the pandemic ends, he added.

Therefore, “I see collaborations coming. Some of the small companies have unique technologies, so there is likely to be a lot of out-licensing and open- or private-label agreements for those products,” Parker said.

Acquisitions, he said, are less likely, simply because it will be less attractive to acquire a smaller innovator when the goal is to tuck the additional assay into the larger company’s COVID-19 product line.

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