Quest Diagnostics Launches Patient-Ordered Covid-19 Antibody Test

Quest Diagnostics (NYSE:DGX) announced today that consumers can now order a COVID-19 antibody test it launched last week directly from the company, without visiting a doctor’s office.

The Secaucus, N.J.-based testing giant said consumers can purchase the antibody test service online for $119 through its QuestDirect business. They will be prompted to schedule an appointment for a blood draw at one of the 2,200 patient service centers Quest Diagnostics operates around the U.S. They must not have experienced symptoms of COVID-19 for at least 10 days; wear a face mask; and pass a contact-less temperature check.

The company is using tests developed for high-throughput environments, starting with one launched yesterday by Abbott and another by Euroimmun/PerkinElmer (NYSE:PKI). The Abbott received an Emergency Use Authorization from the FDA and the Euroimmun test has been released for use under an emergency FDA guidance updated March 16, 2020 but has and has not been reviewed by the FDA.

Each test request is reviewed and, if appropriate, an order for testing will be issued by a licensed physician working for PWNHealth, an independent national network of physicians is providing clinical oversight for QuestDirect. PWN will also deliver test results and post-test telehealth support to patients, according to Quest. Consumers may also speak with a physician about their results.

Test results are available within two days and may indicate exposure to and antibodies for  COVID-19, also known as SARS-CoV-2, according to the company. The FDA has said it’s unknown whether the development of antibodies to COVID-19 provides protection from re-infection, or how long such protection lasts. The serology antibody tests run by Quest Diagnostics are either approved by the FDA under an emergency use authorization, or were released for use under the FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” updated March 16, 2020, and have not been reviewed by the FDA, the company said.

“With the introduction of this test and service, Quest is making it easy for people to access quality testing for antibodies to the virus which causes COVID-19, with access to physician interpretation and steering into needed care,” said Dr. Jay Wohlgemuth, SVP and chief medical officer for Quest Diagnostics, in a news release. “While the science on COVID-19 is evolving, testing for antibodies may identify people who have likely been exposed to COVID-19 and might have mounted an immune response to the virus.  Our goal is to empower individuals and their physicians to make informed decisions about their risk of infection and of spreading the virus.”

Quest said it provides data on COVID-19 testing to federal and state public health authorities, including the Centers for Disease Control and Prevention, and participates in studies with government and private institutions.

According to the FDA, results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.-Mass Device