Unauthorized COVID-19 Tests Penetrate Market
The dangers of a fraudulent COVID-19 test can potentially mean the difference between life and death. It’s one of the reasons that both the City and County of Los Angeles are tackling a bounty of false claims now being made by businesses attempting to capitalize on people’s fear in pursuit of profit.
“Fraudulent medical testing can give consumers a false sense of hope. A false sense of hope can contribute to the spread of the virus,” Head Deputy District Attorney Stanley Williams told the Courier.
On May 1, City Attorney Mike Feuer and L.A. County District Attorney Jackie Lacey jointly filed a case against Beverly Hills- based Applied BioSciences Corp. on Wilshire Boulevard for unlawfully advertising and selling an in-home COVID-19 antibody blood test that had not been approved by the U.S. Food and Drug Administration (FDA). The complaint, which seeks an injunction, restitution to consumers and civil penalties, marked the first joint filing by the County and City in a COVID-related consumer action.
“There are a lot of individuals and businesses that are trying to take advantage of
people’s fears during this time,” Supervising Deputy City Attorney Christina Tusan told the Courier. “The problem is pretty significant given that this is new and emerging.”
The investigation by Lacey and Feuer revealed that Applied BioSciences allegedly marketed their antibody test to homes, schools, hospitals, law enforcement, military and public servants, with the claim the $35 tests could diagnose COVID-19 with “96.3 percent accuracy” in just “15 minutes” from a single finger prick of blood, according to the complaint.
The case marks the third civil lawsuit filed by the City Attorney’s office against companies that advertise and sell at-home exposure and immunity test kits for the virus that haven’t been approved by the FDA. In addition to having issued a number of cease and desist letters, Tusan said the City Attorney is also looking at additional cases.
“It’s really important that the antibody test be done by a medical doctor or an approved establishment,” said Williams.
There are currently two types of COVID- 19 tests, the PCR (molecular) swab test to detect the coronavirus that causes COVID- 19, and the antibody (serology) test, where blood is collected to determine if a person has been exposed to, and recovered from, COVID-19.
While L.A. County now performs more than 10,000 swab tests a day, the antigen test is more difficult to come by. As of May 11, the FDA had conferred emergency use authorization (EUA) to 12 antibody tests, with an additional 200 antibody tests currently the subject of a pre-EUA or EUA review according the FDA.
Beverly Hills Medical Advisory Task Force and Health and Safety Commissioner member Dr. Lee Hilborne, M.D., a UCLA Health Professor of Pathology and Laboratory Medicine listed four places offering reliable tests: Cedars-Sinai, UCLA Health, Quest Diagnostics, and LabCorp.
He explained that the antibody tests are useful for public health purposes.
“We don’t even know if this antibody confers immunity, although we think it does,” he told the Courier. “At this point, it is important for our health leaders to know the percent of people with antibodies, and the rate with which antibody prevalence is increasing.”
Beginning the week of May 18, One Medical in Beverly Hills will offer free antibody testing for residents working with LabCorp using a test authorized by the FDA. One Medical District Director Jason W. Chirichigno, M.D., told the Courier that locals can access the normally subscriber-based practice’s services free for a month using the code BEVHILLS30 and will not be auto-enrolled or billed a membership fee at the end of the 30-day period. The primary care practice, which usually charges a $199 annual fee for patients, integrates on-demand 24/7 virtual care with in-office and lab services.
“Widely available COVID-19 testing is crucial for getting Beverly Hills residents back to work and school,” Chirichigno told the Courier. ”We’re pleased to make this essential service more widely accessible to Beverly Hills residents during this time of need.”
For weeks now, One Medical has been offering PCR testing at a designated open-air testing site in Century City. Patients who want an antibody test should first book a remote visit before going to the Beverly Hills lab to have their blood drawn.
As restrictions continue to relax and testing becomes more widely available, Pamela Mottice-Muller, Director of Emergency Management, Resilience and Recovery for the City of Beverly Hills, underscored the importance of not letting “our guard down.”
Earlier this week Los Angeles County Public Health Director Barbara Ferrer said the stay-at-home order would be extended indefinitely and that data would be fundamental to lifting it.