Luminex Nabs FDA Clearance for ARIES GBS Assay
AUSTIN, Texas, Jan. 4, 2017 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES® Group B Streptococcus (GBS) Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the FDA has cleared for use on the Luminex ARIES® Systems. The company has also achieved CE-IVD marking for the ARIES® GBS Assay.
Infection with Group B Streptococcus (GBS), also known as Streptococcus agalactiae, is a leading cause of neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers. One in four pregnant women are colonized with GBS, with most not exhibiting symptoms; however, it can be transmitted to the newborn during delivery. If not treated, GBS can result in illness or even death in the first week of a newborn's life. The Centers for Disease Control and Prevention recommends universal GBS testing of women in their 35th-37th week of pregnancy.1
The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus nucleic acid from 18-24 hour Lim broth enriched vaginal-rectal swab specimens obtained from pregnant women. It offers higher sensitivity and increased accuracy when compared to culture, and a reduced turnaround time of two hours after enrichment, compared to 48 hours for culture, with simultaneous STAT and batch testing on the sample to answer ARIES® Systems.
"We found the Luminex GBS assay to be user friendly, and its streamlined workflow is simpler than most other tests we have evaluated," said Thomas E. Davis, MD, PhD, Culbertson Professor of Pathology at Indiana University. "Fortunately, most GBS infections can be prevented by antenatal screening and administration of antibiotics during delivery to women determined to be GBS-positive. By providing fast and accurate results, the Luminex GBS assay could support these efforts to keep women and their babies safe."
"The high level of sensitivity and accuracy of the ARIES® GBS Assay over culture tests will aid in the diagnosis of more patients, ensure better quality of care, and increase patient and clinician confidence in the results," said Homi Shamir, President and Chief Executive Officer of Luminex. "We are delighted to have received our third FDA clearance for an assay indicated for use with our new ARIES® Systems and to launch our first product for antenatal testing, increasing the value we can provide to clinicians, women, and children at a time when their need is at its greatest. We expect to accelerate the launch of additional ARIES® assays as we move into 2017."
About ARIES® Systems
ARIES® Systems are sample to answer molecular diagnostic systems designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES® uses internal barcode scanning and other advanced features to minimize operator errors. Independent modules support from one to six cassettes, allowing for both STAT and batch testing of IVD assays and laboratory developed tests (LDTs) with MultiCode® Reagents when using a universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.
To learn more or request a demo, visit: http://www.luminexcorp.com/ARIES
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 www.luminexcorp.com.
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding the available market for ARIES®, future revenue growth anticipated for ARIES®, and the development, testing and regulatory approval progress of our pipeline products, including ARIES® related assays. The words "believe", "expect", "intend", "anticipates", "confident", "will", "could", "should", and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, our ability to launch products on time, the timing of regulatory approvals, the outcome of clinical trials as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
References:
1. About Group B Strep. Centers for Disease Control and Prevention (Internet). Cited 2015 June. Available from: http://www.cdc.gov/groupbstrep/about.
Contacts:
Luminex Investor Contact
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing
cvalle@luminexcorp.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/luminex-corporation-receives-fda-clearance-for-aries-gbs-assay-300385029.html
SOURCE Luminex Corporation
