Qiagen announced several new product initiatives and acquisitions to coincide with JP Morgan Healthcare Conference, as it continues to stake its claim as one of the most diversified life science research tools and molecular diagnostics companies. In short, Qiagen said it plans to develop a digital PCR system based on technology that it is acquiring from Formulatrix, and to develop a handheld, battery-operated device to facilitate use of its QuantiFeron-TB Gold Plus assay for latent tuberculosis infections in resource-poor areas of the world.
Qiagen CEO Peer Schatz discussed these items in more detail in a webcast presentation at the JPM Healthcare Conference.
Qiagen has long been a frontrunner in the real-time PCR market, but digital PCR is one area that it had not yet tackled. That will change with its recent acquisition of digital PCR assets from Formulatrix, a Boston-area company that has been developing a low-cost plate-based digital PCR system called Constellation that it was positioning as a compromise between pricier droplet-based digital PCR systems and traditional plate-based real-time PCR platforms.
Qiagen did not disclose financial details of the deal, but noted that the transaction is expected to be completed by mid-2019 pending US and other regulatory approvals, and that the company aims to launch a product based on the technology in 2020.
Schatz said that Qiagen has been monitoring the digital PCR market for the last few years, calling it “one of the most attractive growth segments in the life sciences.” He said that although it is still a small market in size (about $150 million to $250 million), it is clearly growing, and now represents about 10 percent of the overall approximately $2 billion real-time PCR market.
Qiagen began working with Formulatrix in the past couple of years, and Schatz said that the microtiter-plate format fit perfectly into Qiagen’s existing PCR product portfolio, “allowing a much better integration into sample-to-insight workflows that Qiagen has demonstrated in other areas, as well.”
He noted that Qiagen expects the new product to reduce digital PCR workflows to about 90 minutes from the 300 minutes typical of existing platforms (especially droplet-based ones); to enable five-plex experiments rather than the typical two-plex assays; and to ease scalability through the availability of one-, four-, and eight-plate options.
Although the product will initially be intended for research use only, the digital PCR market is slowly transitioning to molecular diagnostic applications, and Qiagen will likely eventually follow suit, Schatz said.
Another product-development effort underway at Qiagen is for a handheld reader for its QuantiFeron-TB Gold Plus assay for latent TB detection.
Qiagen is developing the reader in partnership with Ellume, a Brisbane, Australia-based developer of digital devices for diagnostics. Ellume is receiving an AUS$21 million ($15 million) investment from Qiagen as part of the agreement.
The company noted that QFT Access tests can be completed in a single patient visit and in about 24 hours, unlike the decades-old skin test that requires two visits and a physician for assessment. The blood sample will be available for retesting, as needed, and data can be stored for later referral. The single-tube test is incubated for 16 to 24 hours, and results are determined in five to 20 minutes on the single-use cartridge. The results will then be displayed in real time on a compact hub, which can be operated using battery or USB power sources and independently of a computer, Qiagen said.
Qiagen is in the final stages of development for the product and expects a 2020 launch. “We believe it will have highly synergistic impacts on our ability to create national and large regional screening programs that address the centralized … and decentralized low-resource settings to create a comprehensive offering to address the TB issue,” Schatz said.
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