US to ‘rein’ in flood of virus blood tests

Lax oversight

WASHINGTON, May 5, (Agencies): US regulators Monday pulled back a decision that allowed scores of coronavirus blood tests to hit the market without first providing proof that they worked.

The Food and Drug Administration said it took the action because some sellers have made false claims about the tests and their accuracy. Companies will now have to show their tests work or risk having them pulled from the market.

Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA approved. The policy was intended to allow “flexibility” needed to quickly ramp up production, officials said.

“However, flexibility never meant we would allow fraud,” Dr. Anand Shah, an FDA deputy commissioner, said in a statement. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans.”

Blood tests are different from the nasal swab tests currently used to diagnose active COVID-19 infections. Instead, the tests look for blood proteins called antibodies, which the body produces days or weeks after fighting an infection. Most use a finger-prick of blood on a test strip.

The revised policy follows weeks of criticism from doctors, lab specialists and members of Congress who said the FDA’s lack of oversight created a Wild West of unregulated tests.

The agency acknowledged Monday that there have been problems with deceptive, false marketing among the 160 tests that have been launched in the U.S. Some companies have claimed their tests can be used at home, although FDA has not allowed that use. Others make unsubstantiated claims about their accuracy. Some US hospitals and local governments have reported buying tests that turned out to be inaccurate or frauds.

So far, the FDA has granted authorization to 12 antibody tests, meaning their methods, materials and accuracy passed muster with agency regulators. Companies with test kits currently on the market without FDA authorization will now be required to submit formal applications to regulators within 10 business days. Companies that launch at a later date will have 10 days to turn over their applications after validating their tests.

Shah

Questions

Health officials in the US and around the world have suggested the tests could be helpful in identifying people who have previously had the virus – with or without getting sick – and developed some immunity to it. But researchers haven’t yet been able to answer key questions that are essential to their practical use: what level of antibodies does it take to be immune and how long does that protection last?

“We’re spending a lot of time and resources on something that is not really a panacea for reopening,” said Kamran Kadkhoda, a lab director at the Cleveland Clinic.

For now, the tests are mainly a research tool for scientists trying to determine how widely the coronavirus has spread among the U.S. population. Those studies are underway but have produced widely different preliminary results, in part, due to variations between tests. Even high-performing tests can produce skewed results when used in a large population where few people have had the virus.

The National Institutes of Health and other federal agencies are also reviewing tests and conducting research into whether they can successfully predict immunity.

FDA Commissioner Stephen Hahn told reporters Monday that his agency’s “careful balancing of risks and benefits shifted to the approach we’ve outlined today,” based on new data from FDA and NIH reviews. Hahn said more than 200 companies are in the process of submitting testing data to the FDA.

Experts who criticized the government’s previous policy welcomed the new evidence requirement.

“We want to make sure that testing in the US is of high quality and that those using the tests understand how the results should or should not be used,” said Dr. Robin Patel of the Mayo Clinic.

Monday’s move is the latest in the Trump administration’s fitful attempt to roll out an effective, comprehensive testing strategy. While testing has ramped up since the outset of the outbreak, state and local governments continue to report shortages of testing supplies needed to screen for the virus and safely ease social distancing measures. A “testing blueprint” released last week by the White House emphasized that states are responsible for developing their own testing plans.

The novel coronavirus (COVID-19) has run rampant in the United States claiming lives of over 68,326 people so far, according to Johns Hopkins University’s tally.

Infected

It noted that the highly contagious virus has also infected at least 1,172,670 people across the US.

Johns Hopkins has counted over 13,000 new cases and at least 640 reported deaths on Monday.

The Institute for Health Metrics and Evaluation at the University of Washington (IHME) has revised higher their projection of the US coronavirus deaths to at least 134,000 by August 4.

Speaking to reporters on Monday, IHME Director Dr. Christopher Murray said they have reached this result after a major revision in their modeling strategy.

He clarified that a team is now using a hybrid approach, and is gathering “mobility data as it gets reported through four different cell phone providers” and using data to reflect the effect of premature relaxation of social distance, which has a substantial effect.

“The effect of this shift in modeling framework is that the number of deaths that we forecast out to August 4, now increases to 134,000 deaths,” Murray said.

Murray said there is “longer tail of deaths,” meaning it will be a slower decline in some states.

On Sunday, US President Donald Trump stated “we’re going to lose anywhere from 75, 80 to 100 thousands people. That’s a horrible thing.”

New York Governor Andrew Cuomo said Monday the coronavirus pandemic kept declining in the State with 226 deaths in the past 24 hours and 9,647 people being admitted to hospitals, a drop from 9,778 cases the day before.

At a news conference, monitored in Kuwait, Cuomo said today was the fourth consecutive day death cases were below 300.

He said the peak was on April 10 when deaths reached 799.

New York, he said, was on the decline and past the peak. Cuomo added daily hospitals’ admissions continued to drop alongside infections and deaths.

Cuomo said reopening of New York would be very difficult because communities still anxious about the disease.

The State, he added, would not take hasty steps that could put lives of people at risk, therefore the drop in cases should continue for at least 14 days.