Is it possible to use a genetic test to predict an individual’s risk of severe infection requiring hospitalization or death from SARS-CoV-2? That is the claim of Australian-based molecular diagnostics company Genetic Technologies Limited. It recently announced an agreement with U.S.-based Infinity BiologiX LLC (IBX) to sell its “COVID-19 Severe Disease Risk Test” to consumers in the U.S. Consumers can purchase the test for $175, which uses a sample of the consumer’s saliva. The Infinity website advertises the test as follows: “Estimate your personal risk of severe disease requiring hospitalization if you were to be infected with SARS-CoV-2 (the virus that causes COVID-19).”
MORE ON: SARS-CoV-2 Genetic Test for Risk
This genetic test was developed from research described on the Infinity website as follows: “The COVID-19 Risk Test uses clinical risk models as well as patient-specific genetic risk markers to better identify a person’s risk of developing severe COVID-19, if ever infected with SARS-CoV-2.” However, several scientists responded to this news with criticism. Science quoted Priya Duggal, PhD, a professor of genetic epidemiology at Johns Hopkins Bloomberg School of Public Health, who stated, “I think it’s premature to use a genetic test to predict a person’s likely COVID-19 severity. We don’t understand exactly what these genetic variants mean or how they affect disease.” The two companies have introduced this test into the United States without review by the federal Food and Drug Administration.
DEMAND FOR COVID-19 TEST FALLS ACROSS U.S.
Pathologists and clinical lab managers have watched the demand for molecular COVID-19 tests fall in most regions of the United States. As of last Thursday, the CDC reported 242,822 SARS-CoV-2 tests were performed on that date. This is a 90% decline from the daily peak in the number of COVID-19 tests recorded on Jan. 6, 2021, when 2.3 million tests were performed. Of equal significance, on June 4 the 7-day moving average percent of positivity for new tests performed fell below 2% for the first time since the onset of the pandemic. These developments are attributed to less demand for testing, including vaccinations, immunity from individuals previously infected, and even the arrival of warmer temperatures as summer approaches.
• Resolve Biosciences of San Jose, Calif. and Monheim am Rhein, Germany, appointed Chris Barbazette to be its new Chief Commercial Officer. He previously worked at EAB Consulting, GenapSys, Agendia, Affymetrix, and ASYST Technologies.
That’s all the insider intelligence for this report. Look for the next briefing on Tuesday, July 6, 2021.