President Donald Trump has recommended states ramp up testing as they start relaxing some of the strict social distancing measures imposed to combat the coronavirus pandemic, which has infected more than 1.3 million people and killed over 80,000 across the United States, according to data from Johns Hopkins. Some say America needs to perform 20 million to 30 million tests a day to begin getting the economy back to normal. But confusion abounds in the industry as companies pursue various testing methodologies and approaches to tackle this key issue.
Most current testing for Covid-19 requires technology available in laboratory settings and needs personnel who know how to run the test and troubleshoot problems. Now there is a movement to develop easy, at-home testing that can be used by the masses by the end of the summer before flu season. The goal: advance technology, so they can be sensitive enough to flag asymptomatic individuals and be user-friendly so they can integrate with mobile devices and transmit data to all those that need it.
It’s a tall order. Last week the National Institutes of Health told scientists if they develop such rapid coronavirus testing, it will offer funds and support an inventor or company with promise.
Many companies are trying to answer the call. Alphabet’s life science business Verily launched a screener and testing website that could help speed up testing for the coronavirus. With the help of company volunteers, it also has helped launch on-site testing in California and is working with pharmacy Rite-Aid.
“We are working with federal, state and local officials on the development of smart testing,” said Verily’s chief medical and scientific officer Jessica Mega, speaking at CNBC’s Healthy Returns virtual conference on Tuesday.
Mega said it is important to understand that the same testing strategies won’t work everywhere.
Rural areas with more social distancing to begin with may have lower infection rates, for example, and less need for testing than hot spots. “We need to get the right tests to the right people. It’s not just testing, it’s smart testing,” Mega said. “In hot spots, we will want to test more frequently.”
There have been over 8 million Covid-19 tests and 1.2 million positive tests, according to the COVID Tracking Project.
A health worker processes a Covid-19 antibody test for a patient at the Diagnostic and Wellness Center in Torrance, California, on May 5, 2020.
Valerie Macon | AFP | Getty Images
Speaking at the CNBC virtual event earlier in the day, former FDA Commissioner Scott Gottlieb said that many of the antibody tests available already from companies are reliable, but no single test result should be used for individual patient decision-making, since there has been a high “false positive” rate. He said no one should think they are in the clear and have developed immunity as the result of one antibody test. The antibody tests should be repeated twice and two positive results achieved to have confidence in the testing’s value.
Health experts at the virtual event noted what could be coming soon is a so-called antigen test that can quickly detect active infections by looking for viral surface proteins.
These could theoretically augment the PCR tests — polymerase chain reaction tests — which are the standard for Covid-19. These diagnostic tests are in widespread use today but challenging to scale up for mass testing, since they require trained personnel to run them.
If they evolve and offer a high degree of accuracy, doctors envision they can be used at home where individuals can get an answer in minutes.
The U.S. Food and Drug Administration has issued the first emergency use authorization for antigen tests to help rapidly detect coronavirus. These tests quickly detect fragments of proteins known as antigens found on or within the virus by testing samples collected from the nasal cavity using swabs and can provide results in minutes.
Becton Dickinson & Company’s CEO Tom Polen said more rapid antigen testing is beginning to allow for faster results, but it is likely to remain limited primarily to physicians offices and pharmacy settings for at least a few months before becoming more readily available for home use.
The workplace is also an environment in which antigen-testing decisions will need to be made. Becton Dickinson has two-thirds of its workers still on the job in manufacturing facilities, and Polen said it has to think seriously about how to keep them safe and, as the antigen tests become more widely available, look at real-time testing as employees come into work, or perhaps come in on a rotating basis.
“Antibodies are why we can fight … but it is not as simple as just having antibodies to know you would not be at risk,” Mega said, adding, “People have different levels of antibodies, and so will take multiple tests to have confidence. How do you get people back to work safely? It’s not just a simple yes/no, green/red light phenomenon.”
There is also some promise in using CRISPR, a gene-editing technique to diagnose the novel coronavirus as quickly as a pregnancy test, Mega noted during the virtual event.
The key is having a national strategy for doing testing in a sensible and equitable way, the health-care experts said.
Polen stressed that even as testing improves in accuracy, speed and access, it will never replace basic precautions, like masks and hand washing.