Lucira Health Inc. has secured U.S. FDA emergency use authorization for the first prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. The single-use, COVID-19 All-in-One Test Kit employs a simple ‘swab, stir and detect’ design that yields results within 30 minutes – enabling individuals who expect they have the virus to get results while isolating at home.
The Emeryville, Calif.-based company plans to shortly begin offering the test kit to patients served by Sutter Health in Northern California and Cleveland Clinic Florida. Nationwide availability is expected by early next spring.
As of Nov. 16, the FDA has issued emergency use authorizations (EUAs) for 223 COVID-19 molecular tests, including nearly a dozen that provide for collection of samples at home. However, the samples must be sent to a laboratory for processing and results. Labcorp won the first such nod in April, when the agency expanded the EUA for its polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit.
In a late Tuesday press release announcing the EUA, FDA Commissioner Stephen Hahn said Lucira COVID-19 All-in-One EUA underscores the commitment to increasing access to COVID-19 testing.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The easy-to-use test kit includes a test device, sample vial, swab and instructions. Users rotate the swab several times in each nostril, then whisk it in the sample vial and press down in the test unit to trigger the start of the test. A blinking light tells users the test is in process. Within 30 minutes, a green light indicates if the result is positive or negative for COVID-19.
To ensure follow-up treatment and support public health efforts, patients are instructed to report their results to the provider who prescribed the test.
The test is authorized for at-home use by individuals 14 years and older. It is also authorized for use in point-of-care settings, hospitals and other care settings for all ages, but must be administered by a clinician if the patient is younger than 14 years old.
“Being able to quickly determine if a person is infected, or not, has been a global problem,” said John Chou, physician with Palo Alto Foundation Medical Group, a Sutter Health affiliate, and a principal investigator on the Lucira Health Community Testing Study submitted to the FDA. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently.”
Lucira validated the test in a diverse population of more than 100 people in southern and northern California, including the San Francisco Bay area. Per the study’s design, patients suspected of having COVID-19 tested themselves outside their homes while being observed by a trained professional. Results showed that 100% of subjects were able to successfully perform the test.
To demonstrate efficacy, Lucira said it compared the test to one of the most reliable FDA-authorized SARS-CoV-2 assays available. The evaluation showed 94.1% agreement on positive results across all samples, and 100% agreement when samples containing low level of virus were excluded. Negative results aligned 98% of the time across all samples.
“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious. Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests,” said Erik Engelson, Lucira’s CEO. “Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests and considered the ‘gold standard’ for determining if someone is infected.”
A separate clinical trial is ongoing with Cleveland Clinic Florida.
Founded in 2013, Lucira had already developed its single-use kit device to test for the flu, but switched its focus to SARS-CoV-2 detection in the wake of the COVID-19 pandemic.
With the EUA in hand, Lucira is now looking to scale up manufacturing of its COVID-19 test. “With a 40- person company, as you can imagine, it’s all hands on deck … get the trials completed and everything properly validated and then submitted, and accommodating the FDA,” Lucira spokesman Kevin Knight told BioWorld. Now “it’s ramp it,” he said, adding the company is still figuring out target production levels.
In the meantime, patients with suspected COVID-19 can get the test via prescription from point-of-care settings and health care networks in the areas targeted in the limited launch. Lucira plans to price the test at about $50 to make it widely accessible.
To make the test even more convenient, the company intends to amend its EUA or seek a new one by the close of 2021 second quarter so that people who fear they’ve contracted the coronavirus can get a prescription via a dedicated website. The test kit would be delivered overnight to the patient’s home.