NEW YORK (360Dx) – Sciex is counting on its newly announced joint venture with Zhejiang Dian Diagnostics to speed its penetration of the Chinese clinical mass spec market, which a company official said is "set to explode."
Factors like the country's interest in multiplexed diagnostic panels and wellness monitoring have its clinical mass spec space "poised for huge growth," said Aaron Hudson, VP and general manager of Sciex's diagnostics division.
He likened the current state of clinical mass spec in China to that of the US and Europe 15 years ago. However, he added, the Chinese market has the potential for even greater growth due to its interest in clinical tests that is not currently well-served by traditional immunoassays.
"I think if you look at [clinical mass spec] in the US and Europe, predominately it is used to displace immunoassays that are just not good enough, things like tests for immunosuppressant drugs or vitamin D," Hudson said.
Such assays are likewise a target for mass spec in China, he said, but there is also higher demand there for assays testing larger panels of analytes as part of wellness monitoring.
"And testing panels of analytes lend themselves really well to mass spectrometry, compared to traditional immunoassays that are more typically [for] single analytes," Hudson said.
Indeed, mass spec's multiplexing potential has long been cited as one of its main advantages in a clinical setting, where the ability to measure dozens of targets in a single run could provide significant advantages in throughput and cost compared to immunoassays. Often, these advantages have been discussed in the context of advanced proteomic or metabolomic tests combining multiple analytes to provide diagnostic or prognostic information. However, such tests have proved challenging to develop and bring to market, and so to date much clinical mass spec activity has focused around using the technology to improve existing, often single-analyte, immunoassay tests.
There is obvious value in developing improved versions of such tests, but, as single-analyte assays, they don't fully leverage the cost and time savings theoretically enabled by mass spec.
Contributing to the appeal of the Chinese clinical mass spec market, Hudson noted, is the perceived demand for panels of established analytes that are commonly measured using mass spec. He cited panels of vitamins, steroids, and commonly measured metabolites as examples of where the company saw the most immediate opportunity for its instruments.
The company's joint venture with Dian will speed Sciex's move into China's clinical mass spec market by helping it satisfy the China Food and Drug Administration's criteria for expedited approval, under which a percentage of the components of in vitro diagnostic tests must be produced in China.
"Our instruments are being put into China at the moment as medical devices and we are getting regulatory approval for them," Hudson said. "But when you think about a diagnostic market, it's really more to do with the clinical value and what assays you can perform on a system."
He noted that laboratory-developed tests are not allowed in China, and so Sciex is focused on developing IVD tests for its instruments.
"In order for us to be able to penetrate the Chinese market in the same way that we're doing with the American market, on anything other than a geologic time frame, we have to [engage] with a company over there and have at least 30 percent of the [IVD] product made in China," Hudson said.
The joint venture between the two companies will be based in Hangzhou, China and will develop, register, manufacture, and commercialize Class I, II, and III in vitro diagnostic reagents for the SciexTriple Quad 4500MD LC-MS/MS system. Hudson said Sciex evaluated a number of potential Chinese partners before forming the Dian agreement, which is exclusive to both companies.
Dian's diagnostic network comprises more than 30 laboratories covering nearly all of mainland China and processes around 100,000 samples per day. The company also has good access and penetration into the Chinese hospital system, Hudson said.
He said the companies envisioned a model in which smaller hospitals without enough sample volume to justify having their own mass spectrometer would send out for testing at Dian's reference labs, which would run the tests using the IVD kits Sciex and Dian developed and Sciex's 4500MD instrument.
In larger hospitals, Sciex will try to place 4500MD instruments, which those facilities will then use to run the Sciex-Dian IVD kits in house under a reagent-rental arrangement, Hudson added.
He said the companies aim to have their first IVD products on the market in China as early as next year, though he noted that development of mass spec-based IVDs is a complicated process, even in the case of analytes commonly tested for using the technology.
"These will be well-known panels that can easily be done on mass spectrometers at the moment," he said. "But just because you can develop an assay for, say, 15 steroids over the weekend, that does not mean it's easy to develop an in vitro diagnostic for [those analytes] where you've got to do it in every lab reproducibly, routinely, every single time, and have regulatory approval for that test."
"So the technology is not hard as far as the mass spectrometry is concerned, but there is certainly some significant work on the research side and development side that needs to go into making these in vitrodiagnostic kits," he added. "I think we as a mass spec community have made that mistake [of underestimating this challenge] before."