Healthcare Industry News: NxTAG
News Release - March 13, 2020
Luminex Provides Update on SARS-CoV-2 Validation Testing EffortsFour independent clinical laboratories report data from evaluation of automated, sample-to-answer ARIES® System for rapid detection of SARS-CoV-2 virus
Luminex has launched and begun shipping its Research Use Only (RUO) NxTAG® CoV Extended Panel
Luminex is planning to submit an EUA (Emergency Use Authorization) for its NxTAG® CoV Extended Panel (RUO) by the end of this month
Luminex intends to submit an EUA for an ARIES® SARS-CoV-2 Assay next month
AUSTIN, Texas, March 13, 2020 -- (Healthcare Sales & Marketing Network) -- Luminex Corporation (NASDAQ: LMNX) announced today that four independent clinical laboratories have validated laboratory developed tests (LDTs) for automated, rapid detection of the SARS-CoV-2 virus using the sample-to-answer ARIES® System. These LDTs demonstrate that high complexity laboratories using the ARIES® System can immediately add novel coronavirus diagnostics to their testing menu. This will be important for helping to address soaring demand for coronavirus tests and will allow laboratories to produce results in approximately two hours.
Studies to verify the test parameters with contrived samples on the ARIES® System were conducted by Baylor Scott and White Health (Temple, TX), Montefiore Medical Center (Bronx, NY), Geisinger (Danville, PA), and the University of Louisville (Louisville, KY).
"As part of our broader work to make a difference in the battle against the coronavirus pandemic, Luminex is supporting laboratories in their efforts to detect and diagnose cases of COVID-19," said Nachum "Homi" Shamir, President and CEO of Luminex. "Independent validation of LDTs on our ARIES® System will help labs to quickly meet the high demand for testing around the world. We are honored that these clinical labs have chosen to develop their coronavirus tests using our ARIES® platform and are pleased that this work can be easily reproduced at the hundreds of labs currently using the ARIES® System."
Along with these validation studies, labs across Europe and the United States are in the process of going live with their LDTs using the ARIES® System, and Luminex intends to submit an EUA for an ARIES® SARS-CoV-2 Assay next month. The platform uses real-time PCR technology that, when combined with its ability to run LDTs, is ideally suited for facilities that need to develop their own lab-specific testing for which there is no commercially available, FDA-cleared assay. The system provides the flexibility to handle STAT or batch testing and is capable of running different assays simultaneously.
Luminex has also launched and begun shipping its NxTAG® CoV Extended Panel (RUO), a unique multiplex panel that addresses the coronavirus pandemic using its existing bead-based NxTAG Technology. A number of labs in the Far East, Europe and North America have already validated this panel and are planning to go live with it this week. In addition, Luminex is planning to submit an EUA for this panel to the FDA by the end of this month.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements relating to Luminex's business outlook, as well as other statements that refer to future plans and expectations, particularly around the development of products to address the novel coronavirus and the potential by Luminex customers or by Luminex to seek Emergency Use Authorization (EUA) or for high-complexity CLIA labs to perform testing for a limited period in advance of potentially obtaining EUA, and around the potential positive or negative impact of the novel coronavirus on our business. Such statements involve a number of risks and uncertainties. Words such as "can," "will," "already," "planning," "intends," and variations of such words and similar expressions are intended to identify forward-looking statements. Statements that refer to or are based on estimates, forecasts, projections, uncertain events or assumptions, and anticipated trends in our businesses or the markets relevant to them, also identify forward-looking statements. Such statements are based on management's expectations as of the date they were first made and, except as required by law, Luminex disclaims any obligation to update these statements to reflect future events or circumstances. Forward-looking statements involve many risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from the company's expectations include changes in market conditions, supply constraints and other disruptions, changes in laws or regulatory policies or initiatives (for example, termination of a relevant EUA declaration), changes in capital requirements, and other factors set forth in Luminex's most recent Annual Report on Form 10-K filed with the SEC and available at Luminex's website at www.luminexcorp.com and the SEC's website at sec.gov.
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