SAN FRANCISCO (GenomeWeb News) – Austin, Texas-based molecular diagnostics and multiplex instruments firm Luminex on Wednesday presented its plans to enter the newborn screening market over the next couple of years.
Luminex President and CEO Patrick Balthrop provided investors at the JP Morgan Healthcare Conference with an overview of the firm's path to commercialization for a newborn screening assay and a gastrointestinal pathogen panel, along with an assessment of the market for the firm's newest instrument platform, the MagPix.
Luminex will be going after a piece of the newborn screening market, which Balthrop estimated to be a $100 million-plus opportunity, with a new assay slated for an initial launch in Europe later this year. The firm also plans to file for US Food and Drug Administration afterward with the hope of a 2012 launch in the US.
The assay would run on a system that combines the firm's LX200 instrument platform with Tecan's Freedom EVO liquid handling platform. The firms inked an alliance this past October to combine the technologies.
Also incorporated into the system is technology Luminex gained from its acquisition of BSD last May that will help automate the sample preparation part of the system. Altogether, the system will be a fully automated, walk-away instrument that will run the new NeoPlex4 assay, a multiplex biomarker-based test.
Balthrop said the firm has factored in an extended review time from FDA in the timeline it has put forward for marketing in the US. He said the assay would be filed as a 510(k).
While Luminex offers three different instrument platforms, the firm has a master device file with FDA for the LX200, so the assay will initially run on that platform. There is a possibility, though, that Luminex could eventually file to run the assay on the other systems, the FlexMap 3D and the MagPix.
Luminex's FlexMap 3D was launched in 2009 and is the firm's high-end offering with a 500-plex capability. The MagPix was introduced in July 2010 and is the firm's low-end offering with 50-plex capability.
Balthrop was optimistic about adoption of the MagPix, saying that he expects the system to eventually be the firm's top seller among the three instrument options. For the third quarter, the firm sold 41 of the MagPix units, and Balthrop said Luminex expects that it sold a roughly equivalent number in the fourth quarter.
The MagPix is taking aim at the small- to mid-size labs that are conducting immunoassay testing with ELISA products. He estimated that there are approximately 135,000 academic researchers working with such products.
In addition to the NeoPlex4, Balthrop said the firm expects to receive a CE Mark in the first half of this year for a gastrointestinal pathogen panel. He said Luminex would have first-mover advantage with the first DNA multiplex test for an unmet need.
In addition, Luminex is developing its RVP Fast assay, a faster version of its currently available xTAG RVP test for respiratory viruses. The new assay is expected to provide results in two to three hours.