US FDA Grants FDA Emergency Use Authorization to Roche’s four-in-One Molecular Test for SARS-CoV-2, Influenza A/B Viruses and RSV

US FDA Grants FDA Emergency Use Authorization to Roche’s four-in-One Molecular Test for SARS-CoV-2, Influenza A/B Viruses and RSV

By, Admin 11 June 2024

US FDA grants FDA Emergency Use Authorization to Roche’s four-in-one molecular test for SARS-CoV-2, influenza A/B viruses and RSV

Overview

Roche announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas liat SARS-CoV-2, influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV).

Words from CEO: Roche Diagnostics

  • “Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO of Roche Diagnostics. 
  • “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”

Rapid Multiplex PCR Diagnostic Tests

  • Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office labs has the potential to provide swift and precise results, expediting clinical decision-making processes. 
  • This approach can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes and healthcare system efficiency.

Respiratory Diseases 

  • According to the US Centers for Disease Control and Prevention (CDC), respiratory diseases in the United States reached high levels during the most recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency department visits. 
  • Hospitalisations due to respiratory illness place a strain on hospitals and can result in delayed diagnosis and treatment for patients. 
  • In the 2023-2024 respiratory season, infants, children, and adults ages 65 and older were observed to have the highest rates of emergency department visits and hospitalisations caused by SARS-CoV-2, influenza, and RSV. 
  • Nationwide, the percentage of recent total deaths due to these respiratory viruses was highest among patients 65 and older.

The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test authorised for emergency use further expands and complements Roche’s broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness, including the following assays: cobas SARS-CoV-2, cobas Strep A, cobas SARS-CoV-2 & Influenza A/B, and cobas influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval.

The cobas liat SARS-CoV-2, influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with Covid-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar.

Limirations for Testing

  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. 
  • The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is authorised for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Results to Detect Influenza C Virus

  • Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. 
  • SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. 
  • Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. 
  • Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease.

Impact of Negative Results

  • Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions. 
  • Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

A/B & RSV Nucleic Acid Test

  • The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas liat system and the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. 
  • The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Cobas liat System & Cobas Liat Analyser

  • The cobas liat system combines the cobas liat analyser – an automated nucleic acid test instrument – with cobas liat assay tubes to fully automate the testing process, simplify workflows, and enable healthcare professionals to perform molecular testing in a variety of near-patient settings with speed, reliability, and minimal training. 
  • The system performs reagent preparation, target enrichment, inhibitor removal, nucleic acid amplification, polymerase chain reaction (PCR) amplification, real-time detection, and result interpretation to automate the detection and quantification of nucleic acid targets in a biological sample in a single closed tube. 
  • Definitive results are generated in 20 minutes or less to aid in patient care decisions. 
  • The cobas liat SARS-CoV-2, Influenza A/B & RSV Assay complements existing tests for SARS-CoV-2 & Influenza A/B, Influenza A/B & RSV, Strep A, and Cdiff. 
  • Assays for other infectious diseases are currently in development. More information is available at diagnostics.roche.com. The cobas liat system is commercially available in select markets.

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