Author: David Bronstein
The FDA has used its emergency use authorization (EUA) process to clear five new rapid SARS-CoV-2 tests.
1. ePlex SARS-CoV-2
On March 19, the FDA cleared GenMark Diagnostics Inc.’s EUA for its ePlex SARS-CoV-2 test. The assay can be run in hospital labs instead of sending the test out to larger diagnostic laboratories, which is required for the two first two FDA cleared for COVID-19 tests by Roche and Thermo Fisher.
The ePlex system enables truly rapid testing, as in most cases, the test is sent to the on-site lab where it can be run in about 1.5 hours. Results can be given quickly to the pharmacist or clinician rather than waiting 24 to 48 hours or more for other test results.
GenMark shipped initial Research Use Only (RUO) tests on March 2 to several key hospitals and laboratories to validate the assay design using clinical samples. This was the first rapid sample-to-answer test available for RUO testing, according to company officials.
Dwayne Breining, MD, the executive director of labs at Northwell Health in New York, one of the RUO testing sites, said managing the level of testing in hospitals is a challenge. “Getting tests to detect COVID-19 in the hands of our physicians and clinicians as soon as possible is one of our highest priorities in combating this rapidly expanding health emergency.”
According to GenMark, that type of feedback is not uncommon. “We are hearing from our customers that since test results are rapid with ePlex, they are using it for more urgent testing of inpatients, ICU patients and health care providers with direct contact with patients,” said Lisa Filippone, the company’s director of Global Product Marketing.
2. Xpert Xpress SARS-CoV-2.
On March 23, the FDA granted an EUA for Xpert Xpress SARS-CoV-2 (Cepheid). The test was designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert systems worldwide, with a detection time of approximately 45 minutes.
The test leverages the design principles of its Xpert Xpress Flu/RSV technology, in which multiple regions of the viral genome are targeted to provide rapid detection of SARS-CoV-2. According to the company, the test provides reference laboratory–quality results.
There are nearly 5,000 GeneXpert systems in U.S. hospitals that are capable of point-of-care testing, according to Cepheid President Warren Kocmond. Users do not require special training to perform the test, and the systems are capable of running 24/7.
“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health care facilities,” said David Persing, MD, the chief medical and technology officer at Cepheid. “An accurate test delivered close to the patient can … help alleviate the pressure that the emergence of the [COVID-19] outbreak has put on health care facilities that need to properly allocate their respiratory isolation resources.”
3. Accula SARS-CoV-2 Test.
On March 24, the FDA cleared the Accula SARS-CoV-2 Test (Mesa Biotech), which yields “diagnostic results in 30 minutes,” the company noted in a press release (bit.ly/2UjuPTG). The Accula test uses polymerase chain reaction technology to detect SARS-CoV-2 via throat and nasal swabs. The test is designed for point-of-care use, including screening facilities, physician office labs, urgent care and long-term nursing facilities.
“Our Accula system is easy to use and fits in the palm of your hand,” Mesa Biotech co-founder and CEO Hong Cai, MD, said in announcing the FDA approval. “This allows many units to be run side by side in the doctor’s office, further increasing the speed of COVID-19 diagnosis.”
4. BIOFIRE COVID-19 test.
On March 24, the FDA cleared BioFire Defense’s BIOFIRE COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2.
The test runs on the fully automated FILMARRAY 2.0 and FILMARRAY TORCH platforms and detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media.
According to the company, the test “is extremely easy to use, therefore requiring minimal training and skills in molecular biology.”
5. Abbott ID Now.
On March 27, the FDA cleared Abbott’s EUA for what the company claimed “is the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.”
According to Abbott, the test provides rapid results “in a wide range of healthcare settings such as physicians’ offices, urgent care clinics and hospital emergency departments.”
ID NOW is a rapid, instrument-based, isothermal system that uses isothermal nucleic acid amplification technology. The system has been available since 2014 and tests for a wide range of infections, including influenza A and B, Group A Streptococcus and respiratory syncytial virus.