NEW YORK (360Dx) – With the recent launch of its mass spectrometry RenataDx Screening System, Waters is looking to reinforce its position in the newborn screening market and serve growing demand for newborn screening in the developing world.
The company introduced the system last month. Combining Waters' Xevo TDQ IVD mass spec, ACQUITY UPLC I-Class IVD Binary Solvent Manager, and the 3777C IVD Sample Manager along with the company's MassLynx and IonLynx software, the platform uses flow-injection tandem mass spec to enable high-throughput analysis of dried blood spots.
The system is manufactured as a US Food and Drug Administration Class I medical device and has the CE-IVD mark.
According to Ben Dugas, health science business development manager at Waters, the system is intended for clinical dried blood spot screening generally, with newborn screening one of the largest markets within that space. Mass spec newborn screening assays test for more than 30 inherited metabolic disorders, and this market is growing as developing countries launch mass spec-based newborn screening programs, Dugas said.
"You have growth in the developing countries who are launching screening programs, and then you have the replacement market [in developed countries], as well," he said, adding that Waters has an estimated 80 percent of the mass spec newborn screening market in the US.
The RenataDx is aimed at labs with needs for higher throughput than a conventional LC-MS system can provide. The flow-injection system skips upfront chromatography, which allows for more rapid assays.
"Typically one [RenataDx] instrument will do about 40,000 samples per year," Dugas said. "So labs who do more than 50,000 samples will have a couple of instruments, or maybe even four or so for backup, just for screening."
"Then there are other labs, depending on the country or the geography, who are doing less than 20,000 [samples] per year," he said. "They will probably just go with an LC-based system."
Screening labs typically use LC-MS systems to confirm positive results, as well, Dugan said.
"The flow injection is much quicker for [the initial screen]… and then when [a lab] gets a presumptive positive [result], they'll typically have an [LC-MS] system to be able to do that confirmation, and it helps them reduce their false positive rate, having this two-tiered strategy in their laboratory."
Waters has partnered with PerkinElmer on mass spec-based newborn screening over the last decade, but Dugan said the launch of the RenataDx represents a move by the company to brand the system more clearly as part of its own portfolio.
"We upgraded the instrument, we brought it into our own medical device portfolio as a Class I medical device, and we branded it [the RenataDx]," he said. "Before it didn't really have a brand."
"With us bringing this into our own medical device portfolio, we're in a better position to offer laboratories who are doing this type of work both [flow-injection and LC-based] approaches," he added. "They can do the screening [on the RenataDx], and they can do their confirmation on UPLC with our other medical [mass spec] devices."