BASEL, Switzerland—Roche capped off 2014 by expanding its testing services footprint with the acquisition of privately held Ariosa Diagnostics Inc., a molecular diagnostics testing service provider that offers a highly targeted and accurate noninvasive prenatal testing (NIPT) service through its CLIA laboratory. Though no financial details were disclosed, the transaction was expected to close in December 2014.
Ariosa’s portfolio features its proprietary Harmony Prenatal Test, a blood test performed as early as 10 weeks into pregnancy to assess a fetus’ risk of Down syndrome and other genetic abnormalities. The test evaluates fetal cell-free DNA found in maternal blood and specifically determines the risk of trisomies 13, 18 and 21, which indicate an extra chromosome in the fetus that could result in severe genetic conditions. The test has been validated to CLIA requirements and supported by clinical studies in more than 22,000 women, and reportedly has a false-positive result of less than 0.1 percent.
“The noninvasive prenatal testing market with cell-free DNA has represented one of the fastest-growing segments in the diagnostics industry,” says Dr. Ken Song, CEO of Ariosa. “For Ariosa’s Harmony Prenatal Test, testing volume has grown from approximately 30,000 women in 2012 to over 200,000 women in 2014. Penetration of the NIPT market is still in its infancy, as the use of NIPT in the global general pregnancy population is just beginning to emerge.”
While the companies haven’t worked together before, both were impressed with each other. Dan Zabrowski, head of Roche Tissue Diagnostics and Roche Sequencing Unit, reports that upon deciding to enter the NIPT market, Roche identified Ariosa as the best partner. For his part, Song says “Roche’s global leadership in in-vitro diagnostics and their focus on innovation made them a natural partner for Ariosa, especially as we look to broaden access for the Harmony Prenatal Test via a kit strategy.”
“We’re seeing a paradigm shift in prenatal screening towards noninvasive cell-free DNA technology where we can identify the risk of aneuploidies with a high degree of accuracy over traditional screening methods,” Song adds. “Cell-free DNA technology allows one to have a direct view into the assessment and monitoring of disease through a simple standard blood draw. This can avoid invasive testing, which often carries with it cost and complications.”
Zabrowski shares Song’s outlook on this technology, noting that “We believe cell-free DNA technology is going to be a game-changer, not only in NIPT but in other disease areas such as cancer, transplant and infectious disease … We think that for us, cell-free DNA technology is an important strategic imperative for Roche to lead in this area.”
He says that going off of analyst estimates, it’s fair to say the NIPT market “has the potential to be a multibillion-dollar market,” adding that though the market is currently focused on high-risk pregnancies, “we believe that with Ariosa we can expand access to an NIPT test that would make it affordable for women who have moderate- to low-risk pregnancies.”
Following the close of the transaction, Zabrowski says Roche will retain Ariosa’s employees and current site in San Jose, Calif.
“We think Ken Song and his management team are excellent. We’re really excited that we’re going to be able to retain everybody at Ariosa, and they’ll continue to be an important part of our strategy going forward,” he tells DDNews. “We remain committed to developing an integrated portfolio that provides our customers with a complete solution for the generation, analysis and management of genomics data, and for us to achieve that, we’re investing internally in potential breakthrough technologies as well as seeking the most innovative technologies externally, as evidenced by the announcements we’ve made this year with the acquisition of Genia, our collaboration with Stratos, the acquisition of Ariosa and the acquisition of Bina.”