miradx
To date, the country has faced testing shortages, confusion about the various testing types, and lack of clarity around who should or can have access to tests. However, that does not mean we can't course-correct by thoughtfully laying the necessary roadmap for more transparent and effective testing guidelines as we look to reopen our economy.
The first step is a clear understanding of the current testing options available. The two predominant tests on the market are viral tests and serum antibody tests:
- Viral, or PCR, tests determine if an individual currently has COVID-19 by testing for the virus itself through a swab of the nose or throat. These tests indicate whether the person is contagious to others, even if they are asymptomatic. Viral tests are complex and can require at least 24 hours to perform and report. The PCR test is considered the gold standard given its 90%+ accuracy rate and ability to detect even low levels of virus.
- Antibody tests determine whether an individual has been infected with the virus and has developed an immune response (antibodies) against the virus. Antibody tests use a blood sample and can be processed relatively quickly, yet they will not identify people with an early infection, nor can they tell whether an individual is no longer shedding the virus and therefore *no longer contagious.
Both types of tests can be delivered as laboratory tests or point-of-care (POC) tests, the latter having the goal of quick turn-around and broad community delivery. However, none of the companies marketing POC tests have published accuracy data based on patient testing yet.
So where does that leave businesses looking to get their workforce back up and running? Businesses must establish protocols for appropriate testing of employees to confirm that they are virus-free before returning to work. Taking someone's temperature is NOT a valid proxy for determining whether an individual is "healthy" nor is an antibody test alone. Instead, we need to develop a clear decision tree that includes the two different types of testing.
Photo courtesy of Joanne Weidhaas
Companies should institute a multi-step COVID-19 testing protocol:
1) Any person who previously tested positive must receive a negative viral clearance test before returning to work.
2) Any person who has no confirmation of prior infection should receive a viral test first. If they are positive for the virus, they must be retested until they receive a negative result. If they are negative for the virus, they should then have an antibody test to determine whether they were previously infected.
If negative for virus and positive on the antibody test, they can also safely return to work. If negative for the virus and negative on the antibody test, they should know they are susceptible to infection if they return to work.
For those who are still susceptible, one option is to allow them back to work, but develop a prospective viral screening protocol. These screening tests could be on a volunteer and rotating basis through the workforce, with perhaps 10%-20% being tested each week. Anyone with symptoms also should be sent home and receive immediate viral testing.
The federal government should be taking action to coordinate testing supply, help direct it to the highest priority populations and subsidize the cost of testing. Business leaders should coordinate efforts to establish testing protocols and sharing of testing resources for the workforce that reflect the most current science to ensure that workers can safely return to, and stay at, work.
Viral testing is the only established method to confirm if an individual is virus-free and therefore safe to return to work. At MiraDx, we are conducting PCR testing for COVID-19 and are seeing many individuals continue to be contagious for weeks after their last symptoms. This is significantly longer than the current CDC guidelines that indicate that individuals are "clear" to return to work 72 hours after fevers and symptoms are gone. We are completing a larger study on this issue and will report results soon.
Dr. Joanne Weidhaas, MD, PhD, MSM is the co-founder of Los Angeles-based molecular genetics company MiraDx, the founder of MiraKind.org, and currently a professor and vice-chair in the department of radiation oncology at UCLA.
*This story has been corrected to say that if you are no longer shedding virus, you are no longer contagious. It previously and improperly said the opposite.
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Indeed, Weidhaas wears multiple hats as co-founder of L.A.-based MiraDx and a professor at the David Geffen School of Medicine at UCLA. Her company actually started 10 years ago after she and her co-founder discovered a new group of RNA biomarkers that MiraDx then used to help determine cancer risk as well as the response to cancer treatment.
Now she's focused on ways to help detect and hopefully stop the spread of the novel coronavirus that has already caused 78 deaths and 4,000 cases in Los Angeles County. So far, MiraDx has been in discussion with several nursing homes to provide tests for their staff and talking with L.A. County about providing tests. The company is geared up to begin running as many as 4,000 tests a day starting Monday and is hoping to run more than 9,000 tests by the end of April.
The company is planning to add staff so that it can run tests 24/7. MiraDx has already processed its first five positive and first five negative results that it planned to submit, per protocol for cleared labs, to the FDA on Friday.
MiraDX is one of a slew of companies that have repurposed their existing businesses to address the lack of resources that local governments and front-line healthcare workers have been facing. It's also one example of L.A.'s relatively recent move into the world of biotech, an area of business that is usually more closely associated with San Diego.
It was the day after Weidhaas' birthday, 2 ½ weeks ago, as the coronavirus was really starting to overtake headlines, that she suddenly realized the company could and should do this with their lab.
Dr. Joanne Weidhaas wears multiple hats as co-founder of L.A.-based MiraDx and a professor at the David Geffen School of Medicine at UCLA. Courtesy of MiraDx
It's been a sleep-deprived, whirlwind ever since. The company has since transitioned its CLIA-certified lab to provide COVID-19 tests for essential works, prioritizing hospital and field-based healthcare workers who provide direct patient care and also first responders.
The company will distribute the tests — which cost $150, — for free to those frontline workers and organizations through (tax deductible) donations from its nonprofit sister organization, MiraKind. So far, the company has raised $75,000 in just a few days.
In order to prioritize essential workers and ensure their test results are processed quickly, Weidhaas said the company is not currently doing any direct-to-consumer testing. The lab should be able to process results within 48 hours, but is hoping to eventually cut that down to as little as four hours, she said. Those results are sent directly to the doctor and also the patient on their website at the same time.
The test uses an oropharynx, or back-of-the-mouth-area, swab. The PCR machine that analyzes the RNA, which is pulled from a patient's sample, is "very sensitive" and is set up to amplify a small an amount of the virus to come up positive, Weidhaas said.
The technique has more than 90% accuracy, she noted, and is the best method for identifying whether someone is sick at the time with COVID-19.
"We just need to help people and this is so right in our mission to do that. It's just this huge, incredible humanitarian need, even though it's kind of a turn in a direction," Weidhaas said.
PCR tests such as MiraKind's are more effective for testing when a person is infected early on. That's because the first antibodies — indicators that your body has fought infection — don't usually appear until seven to 10 days after infection, said Dr. Jeffrey Klausner, a University of California, Los Angeles epidemiologist who is also a Professor of Medicine in the Division of Infectious Diseases and the Program in Global Health.
Weidhaas hopes that the people who participate, like for their breast cancer tests, opt in to provide ongoing online updates about their status so that ultimately more research studies can be done. She also hopes to add data to a heat map to help state and local officials determine where there are high-loads of cases.
While more testing is helpful, Klausner said the big issue right now is that the FDA has been slow to approve home collection of samples that would allow people to mail in their samples like 23andMe and other direct-to-consumer genomic testing kits out there.
"Could you imagine that people could get a home collection box from Amazon.com or other internet (shopping) providers, never leave their house, collect a specimen, drop it in the mail, and two days later get a test result," Klausner said.
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