Luminex's ARIES Flu A/B & RSV Assay Now CE-IVD Marked
Luminex CorpLMNX recently announced the receipt of CE-IVD marking for the ARIES Flu A/B & RSV Assay, which can be used with the company's FDA-approved ARIES system. The recently approved Assay rapidly and accurately detects three key respiratory pathogens: influenza A virus, influenza B virus and respiratory syncytial virus (RSV) from a sample.
The ARIES system is a molecular diagnostics platform designed to deliver increased laboratory efficiency. The system's advanced features like internal bar code scanning, electronic reporting, STAT and Batch testing, together with a simple user interface, are aimed at minimizing operator errors and improving test accuracy.
The system was approved by the FDA last October which paved the way for its launch in the U.S. Following the FDA approval, ARIES received medical device licenses from Health Canada's Therapeutic Products Directorate.
In March, Luminex received CE-IVD marking for the ARIES HSV 1&2 Assay. The latest CE-IVD marking will allow the company to launch the ARIES Flu A/B & RSV Assay in the European markets.
The regulatory milestones expand Luminex's total addressable market. The company expects ARIES to contribute more than $2 million to revenues in 2016, the majority coming from assay sales.
Luminex has submitted its flu A&B/RSV assay to the FDA and expects to get the approval before the commencement of the flu season in 2016/2017.
We believe Luminex has significant growth opportunity from its expanding Assay menu. Moreover, the recently announced takeover of Nanosphere will enable the company to offer automated molecular platforms for both syndromic and targeted molecular diagnostic testing (Verigene and ARIES).
The addition of Nanosphere will contribute revenues in the range of $13--$16 million to this business line, if the deal is completed by Jul 1. Luminex noted that the transaction will be accretive to its adjusted earnings by the end of full-year 2017.
Based on the favorable trends, Luminex raised its full-year 2016 guidance. The company now expects full-year 2016 revenues in the range of $247--$255 million, up from the previous range of $245-$255 million. Second-quarter 2016 revenues are expected between $60 million and $62 million.
Zacks Rank and Other Key Picks
Currently, Luminex carries a Zacks Rank #2 (Buy). Other favorably ranked stocks in the medical sector are Cryolife CRY , Masimo Corp MASI and Edwards Lifesciences EW . All the three stocks sport a Zacks Rank #1 (Strong Buy).