As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA.

Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. Results are intended to aid in the early diagnosis in those showing clinical symptoms of SARS-CoV-2 and assist in the initial screening of patients. The test is for use in point-of-care settings for both symptomatic and asymptomatic people and has a sensitivity of 96.52% and a specificity of 99.68%, according to the company.

The launch comes as part of a partnership with South Korea’s Sd Biosensor Inc., a company with which Roche has a global distribution agreement and launched a rapid antibody test in July. Roche highlighted that the test can be performed in different settings close to the patient – an important aspect either when fast decisions are needed, or laboratory testing is inaccessible.

Thomas Schinecker, CEO of Roche Diagnostics, highlighted the challenges health care systems face in the wake of the pandemic, particularly as testing remains a focus. “Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” he noted.

The company noted that this is the tenth addition to its diagnostic portfolio to help combat COVID-19.

Roche spokesperson Jo Lynn Garing told BioWorld that company does not disclose pricing details but will "certainly price the test responsibly.” The goal is to get the test to as many people as possible where a need is present.

She noted that Sd Biosensor is preparing to file for EUA; more information will be released later.

When asked about additional plans for the space, Garing said the company has been laser focused on COVID-19 since the outbreak began. "The SARS-CoV-2 Rapid Antigen Test is another part of the comprehensive Roche diagnostic portfolio to help health care systems combat COVID-19, which also includes molecular, serology and digital solutions,” she continued. “Roche will continue to evaluate further solutions that could help in the management of patients during and beyond this pandemic phase.”

Analyst questions

At least one group had a few questions about the offering. William Blair analysts noted Sept. 2 that the test will require administration by health care providers. In addition, it “has only been studied on symptomatic patients, is noninstrumented, which will likely limit accuracy (pay attention to limit of detection, not sensitivity or specificity), is not a combination test that includes targets for influenza as well, and comes from a partner … that has had quality issues with its serology test.”

The FDA included Sd Biosensor among the commercial manufacturers of serological tests that have been removed from that notification list and should not be used or distributed.

The analysts also paid close attention to Quidel’s performance in the wake of the antigen tests from Abbott Laboratories and Roche. Last week, Abbott scored an emergency use nod in the U.S. for its near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment.

“Last week[,] we said we see minimal impact to Quidel from Abbott’s (ABT $106.55; Outperform) antigen test approval, and this week we are saying there is even less impact from the Roche announcement,” the William Blair analysts wrote.

And Quidel management appear confident when speaking with William Blair analysts with the new competition. “[T]he company stated it looked forward to head-to-head performance studies where it expects data to favor its Sofia antigen test given it is an instrumented, fluorescence-based test. On a similar note, the company is engaged with the NIH to study its antigen test performance in the asymptomatic population." Data from the study is expected later this year.

Still, key opinion leaders (KOL) who spoke with SVB Leerink analysts said lower priced antigen assays like those from Roche have a place in the market. “One KOL highlighted that the ability to turn around a test in 15 minutes, vs. hours for PCR, is equally as important a parameter as performance when targeting larger populations.”

The analysts had asked the KOLs about the impact of Abbott's assay. They agreed that they do not anticipate any impact to PCR testing volumes. Still, there is room for everyone. “Despite the label and IFU (Instructions for Use) being directed to symptomatic patients, [Abbott’s] Binaxnow test's pricing and ease of access (no instrument) will likely result in asymptomatic use as well,” the analysts wrote. “With a focus on large scale testing for schools and workplaces, we anticipate the demand for any antigen tests will be meaningful, and likely outstrip the available supply.”

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