- LabCorp on Tuesday said it is launching a single-panel test that can simultaneously diagnose COVID-19, influenza A and B, and respiratory syncytial virus, while DiaSorin Molecular announced it received FDA's OK for a flu A/B and RSV test that can run alongside its COVID-19 assay.
- The latest tests follow Roche's news Friday of an emergency use authorization for a combined SARS-CoV-2 and influenza A/B test, as more companies step up efforts to meet demand for diagnostics that can detect multiple respiratory ailments as the fall flu season approaches.
- Other developers with EUAs for combination tests that include the coronavirus are BioFire Diagnostics, Qiagen and the CDC. In addition, Cepheid is developing a four-in-one test, for SARS-CoV-2, flu A/B and RSV, that uses a single patient sample.
Healthcare providers are bracing for a flu season complicated by climbing COVID-19 infection rates. Flu A, flu B, RSV and SARS-CoV-2 infections produce similar symptoms such as cough, fever, chest tightness and aches, but treatments differ, making accurate diagnosis critical. Infection with both SARS-CoV-2 and flu A or B also can increase the severity of respiratory disease and require a combination therapy.
Companies are preparing for a potential surge in patients seeking testing. LabCorp CEO Adam Schechter in July said flu testing has not traditionally been a significant revenue driver for the company, but in the current circumstance it's important to build capacity in preparation for the upcoming season. "COVID-19 together with the flu season is going to be more problematic than where we are today," Schechter said on an earnings call.
LabCorp's new combo panel is allowed by FDA as a lab developed test. The company also submitted an application for an at-home version of the test to be sold via its online platform, Pixel; its authorization remains pending.
DiaSorin is also targeting the opportunity. In a press release Tuesday, it said its Simplexa flu A/B and RSV assay can be partnered with its Simplexa COVID-19 test designed for use with the Liaison MDX instrument, to allow for differential diagnosis of the viruses.
An advantage to combination testing is the need for fewer supplies such as swabs, reagents and personal protective equipment, which are currently in high demand and could be further strained by flu testing needs. The combination tests from Roche, BioFire, Qiagen and the CDC, authorized by FDA, use a single patient sample to test for multiple viruses.
Cepheid also is pursuing an EUA for its four-in-one Xpert Xpress test that is based on a single sample from a patient and runs on the company's GeneXpert system. Meanwhile, Anglo-French biotech Novacyt announced at the end of August it received a CE mark for a similar test.