Roche Receives FDA Emergency Use Authorization for Rapid 20-Minute Quadruple Respiratory Pathogen Test

Jun 12, 2024 12:40 CST Updated 12:40

Roche

Oncology Drug Research, Development, and Manufacturing

Source: 360Dx, compiled by IVD Professionals Network, reference: Chenghui Medical

Roche announced on Monday that its four-in-one molecular test kit for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received emergency use authorization from the U.S. Food and Drug Administration.

Roche said in a statement,Cobas Liat SARS-CoV-2, Influenza A/B, and RSV Nucleic Acid Test can qualitatively detect and differentiate viruses from a single nasopharyngeal or anterior nasal swab sample within 20 minutes.The test is authorized for use at the point of care.

The company added that it intends to seek 510(k) clearance and CLIA waiver for the PCR-based test next year, and plans to commercially launch the test in other markets after it receives CE-IVDR approval.

Roche Diagnostics CEO Matt Sause said in a statement: "Diagnostics play a critical role in the fight against respiratory diseases." "We are proud to offer this innovative test to address the heavy burden on healthcare systems. Healthcare professionals will now be able to detect and differentiate these respiratory viruses during a single patient visit, improving public health outcomes."

1.1 cobas^® Liat^®Analyzer

Cobas^®Liat^®The analyzer is a PCR molecular diagnostic POCT platform with innovative functions. The analyzer is controlled by a combination of hardware buttons and a touchpad. The test tube also serves as the swab preservation tube, inserted from the top port of the analyzer, and can only load one sample at a time.

Power Supply: Input 100-240V AC/50-60Hz; Output 15V DC/8.6A;
Dimensions: Height 19.0cm; Width 11.4cm; Length 24.1cm; Weight 3.76kg;
Barcode: 39, 93, 128 -A & -B, Codabar, Databar-14, EAN-8, EAN-13, GS1, Interleaved 2 of 5；
Environmental Requirements: Temperature 15~32℃; Relative Humidity 15%~80%; Altitude 2000m;
Data and Display: Approximately 20,000 test results with date and time can be stored (depending on file size).Supports HL7 and POCT1-A connectivity; PCR curve display;

The analyzer, due to its compact and portable design, can be used in clinical, laboratory, and outdoor settings. Before testing, simply add the sample to be tested into the test tube配套 provided with the analyzer, scan the code, and then insert the test tube into the analyzer's detection slot.

In addition, the analyzer also includes a sample volume detection function and reagent batch identification. The test tube contains internal controls, which can monitor the system operation process in real time to ensure the normal progress of the testing process.

1.2 cobas^®Test Tube

Previously, there were four types of cobas® Liat® test tubes: Strep A, Influenza A/B, Influenza A/B & RSV, and Cdiff.

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Roche Receives FDA Emergency Use Authorization for Rapid 20-Minute Quadruple Respiratory Pathogen Test

Roche

1.1 cobas® Liat®Analyzer

1.2 cobas®Test Tube

1.1 cobas^® Liat^®Analyzer

1.2 cobas^®Test Tube