NEW YORK (GenomeWeb) – Mass spec made progress toward the clinic this week as AB Sciex and Thermo Fisher Scientific released new US Food and Drug Administration-listed Class I instruments at the American Association for Clinical Chemistry annual meeting in Chicago.
Thermo Fisher announced the launch of a clinical LC-MS system consisting of its Prelude MD HPLC, Endura MD triple quadrupole, and ClinQuan MD software – the first LC-MS components the company has listed with FDA as Class I devices.
AB Sciex, meanwhile, announced it will release this fall its 4500MD Triple Quad and 4500MD QTRAP mass spec systems. The company plans to release the instruments as Class I devices in the US and as CE-IVDD marked devices in the EU where it will also release a series of IVD kits for vitamin D, immunosuppressant, and newborn screening testing on the platforms.
The AB Sciex releases follow the launch last year of the company's 3200 MD Triple Quad and QTRAP mass specs, which are likewise designated Class I and CE-IVDD marked devices.
The 4500MD instruments are intended as an upgrade over these machines for customers who need increased performance, Tamara Smith, clinical global market manager at AB Sciex, told ProteoMonitor. Both instruments, she said, offer essentially equivalent performance to AB Sciex's research-use-only 3200 and 4500 lines, both of which can be used for targeted protein quantitation.
In Europe, the instruments' CE-IVDD designation allows AB Sciex to offer IVD kits for use on the platforms. In the US, however, the machines are aimed at the laboratory-developed test market. In 2011 FDA issued a draft guidance instructing that companies using mass specs as part of LDTs should use only Class I registered devices in their assays. At that time, among major vendors only Waters had registered any of its mass specs. Since then, in addition to AB Sciex and Thermo Fisher, Agilent and Shimadzu have registered instruments as Class I devices, and Bruker has moved its MALDI Biotyper instrument through 510(k) clearance.
To move out of the LDT arena into FDA-cleared IVD kits, vendors will need to take their instruments through 510(k) clearance, a process that Smith said AB Sciex is interested in moving towards, particularly given the relatively limited number of labs capable of developing LDTs.
"It's a very select number of users that are capable of developing their own [LDTs], and to get this technology in the hands of those [other] users, we know we need to have a complete solution that is a validated kit on a specific instrument, and we are looking into doing that," she said. "It's a long process, so it's not something that I can say tomorrow we're going to be introducing our first kits, but we know that's a need and we are committed to serving the needs of our customers."
Perhaps reflecting the limited size of the LDT market, or caution in the clinical community regarding mass spec more generally, AB Sciex's 3200 instruments have sold relatively slowly. Smith said the company had a "growing base" of the instruments, but she put sales numbers since their launch last year in the range of the "dozens."
Bradley Hart, Thermo Fisher's strategic director of life sciences mass spec and clinical research, said that his firm similarly aims ultimately to take its mass specs down the FDA-clearance route.
"This is the first set of instruments in what we consider a larger initiative," he told ProteoMonitor. "I think you see the whole industry going down the path of simplification, more for-purpose-use instruments that happen to have mass spectrometers in them … because there is a large opportunity there."
Much industry discussion and activity revolves around mass spec replacing immunoassays, particularly for measuring analytes where immunoassays don't work well, he said, noting that market reports put the immunoassay market at around $20 billion.
"So if mass spec can displace those tests in the areas where they don't perform well, there is a big opportunity," he added.
To a limited extent this is already happening with companies like Quest Diagnostics, ARUP, and Mayo Medical Laboratories turning to mass spec for measuring the thyroid cancer tumor marker Tg in cases where autoantibody interference make standard immunoassays ineffective.
Hart noted that, unlike a number of other Class I mass specs, which are essentially the same as their RUO counterparts, the Thermo Fisher releases were designed specifically for the clinical market.
With regard to the Prelude HPLC, this means features like a syringe pump to reduce maintenance and add simplicity and robustness, while on the mass spec side of things, the Endura MD features a limited number of operations compared to the RUO version.
"The user interface and choices are all simplified with one thing in mind – clinical lab quantitation," Hart said. "All the other bells and whistles and tools you might see when you are operating an RUO version are hidden or gone."
Likewise, the ClinQuan MD software is intended to simplify clinical quantitation as much as possible, he noted. The software features three-tiered access to functions with different permission levels for directors, managers, and technicians.
In terms of future instrument registration, Hart said that with the exception of the highest end discovery-focused machines like the Orbitrap Fusion, all instruments in the company's life sciences mass spec portfolio were potential candidates.
One instrument the company has in the past cited as a potential clinical tool is its Q Exactive, which has become popular with researchers interested in using high-resolution mass spec for targeted protein quantitation.
Hart declined to comment directly on whether the company might in the future seek to register the Q Exactive with FDA, but he said that expected high-resolution instruments would continue to gain ground on triple quads as the technology of choice for targeted quantitation.