Tag Archives: Luminex

Sept. 26, 2023—Streck announced that its MDx-Chex for BC-GP and MDx-Chex for BC-GN quality controls, designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for blood stream infection and sepsis, have been granted FDA clearance for use in diagnostic procedures.

June 2022—DiaSorin announced that Luminex, a DiaSorin company, CE marked its xMAP NxTAG Gastrointestinal Pathogen Panel (GPP). The new panel is a multiplex test that detects nucleic acids from 16 clinically relevant bacterial, viral, and parasitic pathogens in stool samples on the Magpix system.

April 12, 2021—DiaSorin has signed a definitive merger agreement to acquire Luminex for a total equity value of about $1.8 billion.

September 2020—Luminex Corp. announced that the FDA issued an emergency use authorization for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay. The assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for human serum and plasma (>14 days post-symptom onset) in clinical studies.

July 23, 2020—Luminex Corp. announced that the FDA issued an emergency use authorization for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay.

July 6, 2020—Luminex Corp. has submitted an emergency use authorization request to the FDA for its xMAP SARS-CoV-2 Multi-Antigen IgG assay.

December 2019—Luminex Corp. has received FDA 510(k) clearance for the Aries MRSA Assay.

April 2019—Luminex has completed its acquisition of MilliporeSigma’s flow cytometry portfolio for $75 million. The flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis and the Guava portfolio of microcapillary flow cytometry systems. “The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we are well positioned to support customers today and into the future,” Homi Shamir, president and CEO of Luminex, said in a press release. “With this acquisition, we now have expanded our installed base to include more than 5,000 flow cytometry systems worldwide, adding to our impressive footprint and creating the potential for additional meaningful growth.” The buyout is expected to contribute $40–$50 million in revenue to Luminex this year.

Jan. 14, 2019—Luminex has completed its acquisition of MilliporeSigma’s flow cytometry portfolio for $75 million. The flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis and the Guava portfolio of microcapillary flow cytometry systems. “The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we ...

A white paper titled “Can Global Testing for C. difficile Carriers Help to Prevent Healthcare-associated CDI?” from Luminex discusses the results of two recent studies that show that performing C. difficile testing only in patients with clinically significant diarrhea may be missing an opportunity to prevent CDI transmission from asymptomatic carriers. Download the white paper.

August 2017—Luminex received FDA clearance for the Aries Bordetella Assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

May 2016—Luminex received medical device licenses from Health Canada’s Therapeutic Products Directorate, Medical Devices Bureau, for the Aries System and Aries HSV 1&2 Assay; both were FDA cleared in October 2015 and were subsequently launched in the U.S. market.

May 2016—Luminex is collaborating with the Laboratory of Molecular Evolution and Bioinformatics, Biomedical Sciences Institute, University of São Paulo, Brazil, to validate a multianalyte Zika virus assay developed by Luminex partner GenArraytion.

December 2015—Luminex received FDA clearance for its Aries System and Aries HSV 1&2 Assay. Aries is a sample-to-answer molecular diagnostics platform designed to increase laboratory efficiency, ensure result accuracy, and fit into a lean laboratory environment.

December 2015—Luminex received CE-IVD marking for its NxTAG Respiratory Pathogen Panel. The panel detects 21 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila.

December 2015—Luminex and Bio-Techne have signed a new distribution and supply agreement through 2020.

November 2015—Affymetrix and Luminex announced a distribution agreement under which eBioscience, a business unit of Affymetrix, will sell Luminex’s Magpix, Luminex 200, and Flexmap 3D multiplexed assay platforms in specified countries in the Americas, Asia, and Europe.

June 2014—XTAG GPP from Luminex is a qualitative molecular multiplex test intended for the detection and identification of 11 gastrointestinal pathogens, including bacteria, viruses, and parasites.

Luminex announced it has received FDA and European clearance for a comprehensive genotyping assay, xTAG CYP2C19 kit. This new test provides a personalized approach to determining patient treatment based on certain genetic variants of the P450 2C19 gene.

Luminex has received FDA clearance for its Magpix instrument with the xTAG gastrointestinal pathogen panel (xTAG GPP). This is the first clinical assay to be cleared on Magpix. xTAG GPP simultaneously detects 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

Luminex has received FDA clearance for its xTAG gastrointestinal pathogen panel (GPP), which is a comprehensive molecular diagnostic assay that tests for greater than 90 percent of bacterial, viral, and parasitic causes of infectious gastroenteritis.