Luminex Corp. (LMNX) Receives FDA EUA for Zika Virus Molecular Detection Assay
- S&P 500, Nasdaq set records as tech, banks lead
- Texas Instruments (TXN) Tops Q4 EPS by 20c, Issues Solid Q1 Outlook
- Intuitive Surgical (ISRG) Tops Q4 EPS by 10c; $2B Accelerated Share Repurchase
- Seagate Technology (STX) Tops Q2 EPS by 30c
- After-Hours Stock Movers 01/24: (BOBE) (STX) (WDC) Higher; (NEWT) (MRCY) (CA) Lower (more...)
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
Luminex Corporation (Nasdaq: LMNX) announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen).
Designed by Luminex partner, GenArraytion, Inc., the xMAP® MultiFLEX™ Zika RNA Assay detects Zika viral RNA in serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen). The Zika virus can be detected in blood and urine, and in July 2016, the Centers for Disease Control and Prevention updated its guidance to clinicians to recommend serum and urine testing for specimens collected < 14 days after symptom onset. The xMAP® MultiFLEX™ Zika RNA Assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.
The xMAP® MultiFLEX™ Zika RNA Assay is available for purchase by laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The multi-target assay uses the Luminex® 100/200™ or MAGPIX® instrument, or other authorized instruments, to simultaneously test for six genetic targets of the Zika virus.
"We are pleased that our innovative xMAP MultiFLEX Zika RNA Assay has been granted Emergency Use Authorization by the FDA. Together with our partner, GenArraytion, Inc., we have responded to this crisis and are currently in discussions with key public health, reference and hospital laboratories," said Nachum "Homi" Shamir, President and CEO of Luminex. "As a leader in multiplex diagnostic testing for infectious diseases, we are proud to help enable healthcare providers to rapidly detect Zika virus with this assay today, and we intend to expand our coverage to include a broader array of mosquito-borne disease agents in the future to aid in treatment decisions for potentially afflicted patients."
R. Paul Schaudies, CEO of GenArraytion, Inc. commented: "Luminex molecular assays simultaneously detect multiple Zika targets and can detect the disease-causing viral pathogen earlier than serology assays. We are excited to use the highly flexible Luminex platforms for the development of key emerging infectious disease markers."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- DexCom (DXCM) Announces Publication of Study in JAMA Demonstrating Value of CGM in Reducing A1C and Hypoglycemia
- Ashford Hospitality Prime (AHP) Completes Refinancing Of Three Mortgage Loan
- Clean Diesel Technologies (CDTI), DENSO Announce Pact to Provide CDTi's Technology to North American Heavy-Duty Market
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!