Tag Archives: BioMerieux

April 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel. The multiplex PCR test is for the detection and identification of nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab in case of a pharyngitis syndrome. Results are available in about 15 minutes on the BioFire SpotFire system.

April 2, 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel.

Feburary 2024—BioMérieux has acquired the entire share capital of software company Lumed, increasing its stake from 16 to 100 percent. The acquisition of 84 percent of the capital represents an investment of about $9.75 million.

Jan. 11, 2024—BioMérieux has acquired the entire share capital of software company Lumed, increasing its stake from 16 to 100 percent.

November 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood test measures the concentration of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1), two brain biomarkers that are released into the bloodstream during the first hour following a brain injury. It aims to fill a gap in patient screening methods by ruling out acute intracranial lesions and helping to determine if a CT scan is necessary.

Oct. 17, 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood test measures the concentration of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1), two brain biomarkers that are released into the bloodstream during the first hour ...

Sept. 25, 2023—BioMérieux has submitted the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel to the FDA for a dual 510(k) clearance and CLIA waiver.

January 2023—BioMérieux announced the CE marking of its Vidas Kube, a next-generation automated immunoassay system for the company’s Vidas range. The system features a stackable and modular benchtop design and is compatible with the existing routine test menu covering emergency and critical care, immunochemistry, and infectious diseases. The commercial launch is planned in selected countries at the beginning of the year, extending gradually to the rest of the world during the second quarter.

Feb. 8, 2023—BioMérieux has received FDA 510(k) clearance and a CLIA waiver for its BioFire SpotFire system and respiratory panel.

September 2022—The FDA has cleared the BioMérieux Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.

Aug. 24, 2022—BioMérieux announced that its Specific Reveal rapid antimicrobial susceptibility test system has received a breakthrough device designation from the FDA.

July 29, 2022—The FDA has cleared the BioMérieux Vidas Nephrocheck assay, for use to detect kidney stress in patients at risk of acute kidney injury.

July 2022—BioMérieux announced the CE marking of its Vidas Anti-Chikungunya IgM and Anti-Chikungunya IgG tests to diagnose Chikungunya virus infection. The tests can detect infection during the acute phase and into the chronic phase and run on the company’s Vidas immunoassay instruments.

May 9, 2022—BioMérieux’s BioFire joint infection panel has received FDA de novo authorization.

April 12, 2022—BioMérieux has entered into an agreement to acquire Specific Diagnostics, a privately held U.S.-based company that developed a rapid antimicrobial susceptibility test system.

March 18, 2022—BioMérieux announced the Vitek MS Prime, its new MALDI-TOF mass spectrometry identification system, received FDA 510(k) clearance.

September 2020—BioMérieux received emergency use authorization by the FDA for its Vidas SARS-CoV-2 IgM and Vidas SARS-CoV-2 IgG serology tests.

Aug. 14, 2020—BioMérieux received emergency use authorization by the U.S. Food and Drug Administration for its Vidas SARS-COV-2 IgM and Vidas SARS-COV-2 IgG serology tests.

May 29, 2020—BioMérieux’s BACT/Alert BPA and BPN culture bottles received 510(k) clearance from the FDA for Large Volume Delayed Sampling of leukocyte-reduced apheresis platelets and leukocyte-reduced whole blood platelet concentrates with BACT/Alert 3D and Virtuo systems.

March 31, 2020—BioFire Defense, a subsidiary of BioMérieux, has received emergency use authorization by the U.S. Food and Drug Administration for its BioFire COVID-19 test for use in CLIA moderate and high-complexity clinical laboratories to detect SARS-CoV-2.

March 2019—BioMérieux’s BacT/Alert BPA and BPN culture bottles have received 510(k) clearance from the FDA. The culture bottles are for quality control testing of leukocyte-reduced apheresis platelet units and support the growth of aerobic and anaerobic microorganisms in two types of leukocyte-reduced units: apheresis platelet units and both single and pools of up to six units of whole blood platelet concentrates.

April 24, 2018—BioMérieux has acquired Astute Medical, developer of the NephroCheck test, for approximately $90 million. NephroCheck is an ...

October 2017—BioMérieux announced that BacT/Alert Virtuo, its fully automated blood culture system, has received 510(k) clearance from the FDA and is commercially available in the United States and in countries that recognize the CE mark.

July 2017—BioMérieux announced that BioFire Diagnostics, its molecular biology affiliate, celebrated the opening of its Alain Mérieux Center for Molecular Diagnostics facility in Salt Lake City. The facility, home to more than 1,000 employees, is dedicated to the development of FilmArray, BioFire’s molecular PCR multiplex system for the syndromic diagnosis of infectious diseases.

January 2016—BioMérieux and Illumina announced the launch of BioMérieux EpiSeq, a next-generation sequencing service dedicated to the epidemiological monitoring and control of health care–associated infections. The EpiSeq service is the first result of the collaboration agreement signed by the two companies in November 2014.

BioMérieux announced the FDA 510(k) clearance and commercial availability of Vidas 3, the new generation of Vidas. Vidas 3 features enhanced automation, in particular the preanalytical section from the barcoded primary tube including dilution, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Vidas 3 is CE marked and registered at the Chinese Food and Drug Administration.

April 2014—BioMérieux’s molecular diagnostic test THxID-BRAF has been added to the offerings provided by Clarient, a GE Healthcare company.

May 2014—BioMérieux launched its Vidas C. difficile GDH for automated detection of GDH, a specific enzyme produced by C. difficile. Vidas C. difficile GDH is the first automated immunoassay cleared by the Food and Drug Administration.

February 2014—BioMérieux is moving forward with its comprehensive automation solution for reference or centralized molecular biology laboratories and has selected Life Technologies’ 7500 instruments as its preferred thermocyclers.

BioMérieux’s Labguard is a real-time wireless, automated, temperature-monitoring solution for hospitals, laboratories, blood banks, and pharmacies. The solution features real-time, 24/7 Web-based monitoring with alarm display and notifications via SMS, e-mail, and fax. The solution has sensor probes for different applications, including temperature, humidity, pressure, and other physical parameters.