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Roche announced on January 22 that one of its tests based on the Cobas Liat platform for detection and differentiationPoint-of-Care Test Kits for Chlamydia, Gonorrhea, and Mycoplasma InfectionsHas obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) waiver.
Roche has previously obtained separate testing for the Liat assay.CT/NGAnd detection such asSARS-CoV-2, Influenza A Virus, Influenza B VirusAndGroup A StreptococcusTargets and CLIA Exemptions: Roche's Liat Clostridium difficile test has been approved for use in CLIA-certified laboratories that can perform moderate complexity tests. Roche stated that its Liat tests for detecting the novel coronavirus, influenza A virus, influenza B virus, and respiratory syncytial virus received Emergency Use Authorization in June, with other infectious disease tests currently under development. Roche also announced that the CT/NG/MG test will be launched exclusively in the U.S. in the coming months, followed by commercial rollout according to CE certification standards.Acquired in 2014, began to gain recognition in 2021IQuum, founded in 1998, is headquartered in downtown Boston, USA. It is a biotechnology company that develops molecular diagnostics and biosample technologies. Its well-knownLIAT System (Laboratory-in-a-tube), is a novel biosample detection platform. The earliest detection system developed based on this platform is the Liat analyzer and the Liat Flu A/B assay kit.The company, inAugust 6, 2014Acquired by Roche Group450 millionDollarAcquisition. The acquisition of IQuum marks Roche's official entry into the POCT segment of the molecular diagnostics field.According to this timeline,IQuum was founded two years later than Cepheid, but IQuum was acquired by Roche two years earlier than when Cepheid was acquired by Danaher. However, during the COVID-19 pandemic, the performance of Liat was unsatisfactory. At the beginning of 2020, when the COVID-19 outbreak occurred, GeneXpert’s sales skyrocketed from $1 billion in 2019 to $3.8 billion in 2021, yet there was no news of significant sales success for Cobas Liat.- November 2014Announcement: cobas® Strep A Test Receives FDA 510(k) Clearance
- February 2021Roche's Cobas Influenza A/B & RSV Nucleic Acid Test for use on the Cobas Liat system has received FDA 510(k) clearance.
- June 2021Roche Obtains FDA EUA for Cobas SARS-CoV-2 Nucleic Acid Test on Cobas Liat System
- February 2023Roche Obtains Approval for Cobas Influenza A/B and RSV Nucleic Acid Tests on the Cobas Liat System
- September 2023Roche's cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test Receives EUA, Available for Use on the cobas Liat System.
- June 2024The quadruple molecular test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
- January 2025Point-of-care test kits for Chlamydia, gonorrhea, and Mycoplasma infections have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) waiver.
From the registration timeline, 2014After IQuum was acquired,There were very few registered products on the Liat platform, and from 2014 to 2021, it was basically in a state of stagnation. In February 2021, when Liat obtained the combined influenza and respiratory syncytial virus test, Cepheid's COVID-19 test kit had already been on the market for a full year. By the time the quadruple combination test for influenza, respiratory syncytial virus, and COVID-19 was certified in 2024, the wave of COVID-19 nucleic acid testing had long since ended. It must be said that Liat really didn't gain much during this pandemic.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 storage 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 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
cobas® Liat® test tubes are available in four types: Strep A, Influenza A/B, Influenza A/B & RSV, and Cdiff.Source: 360Dx, compiled by IVD Professionals Network, some information provided by Chenghui Medical TechnologyIndustry Group
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