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Pharma Exec. Says FDA ‘Red Tape’ Holding Up Coronavirus Antibodies Test

Dr. Stephen McColgan, chief medical officer at Vivera Pharmaceuticals, California, says his company’s antibody test already exists, Fox News reports.

McColgan, told “Tucker Carlson Tonight” Wednesday that his company’s rapid coronavirus antibody test is ready to be deployed, but is being held up by “red tape” at the Food and Drug Administration (FDA).

“We have a rapid antibody test. And the key to this is, this is part of the solution to the crisis,” McColgan said. “It identifies patients that have immunity and it identifies people that can give plasma [to] critically ill patients.

“It was developed in Germany,” McColgan said. “Germany has the lowest mortality from COVID-19 globally at this point, and they’ve tested everybody. So this is good. It’s used by our allies in Europe.”

McColgan described the test as “high-quality” and “high-value,” adding that its deployment is part of his company’s goal to “get America back to work again and to make America well again.”

According to Biospace, before his interview with Tucker Carlson, McColgan highlighted the benefits of the test stating, “Our antibody test is a game changer, as it identifies the people who have been infected and have immunity with only two drops of blood from a finger prick.  Importantly, it complements the PCR test which defines infection. Identifying individuals who have immunity is paramount because they can now be on the front lines taking care of patients, and potentially providing plasma donations to the critically ill.”

Many experts say antibody testing studies could provide an indication of how many people have been infected and thus help governments to assess the risk of easing restrictions.

“When you have a patient that does have the infection [and] recovered, they have the antibodies, the antibodies mean they have immunity,” McColgan said. “So when you spin off the plasma on their blood and give it to the critically ill patient, then those antibodies fight the viral infection and allow that patient to recover … So it’s critical.”

McColgan said his company has had the test ready for three weeks and was “trying to deploy it.”

“You know, the red tape in the FDA and President Trump has been trying to cut through it,” he said. “I don’t know why New York’s been crying about, you know, no testing, no tests … You know, it’s always sort of the red tape of government moves slowly.”