ORLANDO – Pittcon isn't known as a clinical conference, but there was a fair amount of clinical talk nonetheless from major mass spec vendors at the annual meeting this week in Orlando, Fla.
In particular, AB Sciex's presentation took on a clinical bent, with president Rainer Blair highlighting the company's recent achievement of ISO 13485 certification for its liquid chromatography and mass spectrometry manufacturing facility in Singapore and R&D center in Toronto (PM 2/27/2012).
"This is an important milestone for us along the path to the [European] CE [in vitro diagnostics] mark and subsequently the [US Food and Drug Administration] 510(k) approval for the mass spec in clinical diagnostics," Blair said during the company's Pittcon press conference.
"I can't underline enough how important this is to our growth strategy going forward and ... how important mass spec can be to science and clinical diagnostics," he added. "There is a huge amount of potential for LC-MS workflows in clinical diagnostics, and as the industry starts moving in this direction we'll see some exciting new applications and we're right in the middle of that."
Of particular note was Blair's mention that AB Sciex planned to pursue 510(k) approval for its mass spec instruments. In June 2011 FDA issued a draft guidance on research-use-only and investigational-use-only in vitro diagnostic products in which it said that device manufacturers like mass spec vendors "should not sell such products to laboratories that they know use the product for clinical diagnostic use;" however, this guidance called for mass spec vendors to register their devices as Class I medical devices, a less stringent process than obtaining 510(k) approval.
Industry observers such as Mya Thomae, CEO of IVD regulatory consulting firm Myraqa, have suggested in past interviews with ProteoMonitor that FDA may, in the future, require mass spec vendors to take their instruments through the 510(k) process if they plan to use them for running 510(k)-cleared IVDs. However, in general, vendors have not announced plans to do so.
In an e-mail to ProteoMonitor this week, Joe Anacleto, AB Sciex's vice president of applied markets and clinical research, followed up on Blair's remarks, writing that the company plans to focus on Class I registration "as the next step in our clinical strategy for the US."
He added that AB Sciex believes "that for certain assays a 510(k) submission may be required," but that "this will take significantly more time."
Speaking at Pittcon, Anacleto said that AB Sciex has "tremendous support from [its parent company] Danaher to invest" in clinical mass spectrometry. "Mass spec isn't going to displace immunoassays, but it has its place, it's established that place, and it's building momentum," he said.
Blair noted that Danaher's June 2011 acquisition of Beckman Coulter "changes everything" with regard to AB Sciex's clinical mass spec plans. "Beckman reaches into the clinic in such a broad and deep way that it provides some pretty straightforward channel synergies," he said.
Beckman Coulter has "tremendous expertise in the clinical diagnostics market in general that we can learn from," Anacleto noted in his e-mail. "This ranges from dealing with regulatory bodies, product approvals, go-to-market strategies, and post-launch support."
Beckman Coulter also offers automation equipment and expertise, which are widely considered key to achieving the improvements in throughput and reproducibility that mass spec workflows need to be clinically viable.
"Automation is critical to the diagnostic market, and it is another point of synergy with the Beckman acquisition," Blair said, adding that AB Sciex is "working closely with Beckman's automation group."
The company is also working internally and in collaboration with outside researchers on mass spec-based workflows for clinical proteomics in particular, Anacleto told ProteoMonitor. He declined to give specifics, but said that AB Sciex is "certainly very interested in the proteomics angle of clinical MS."
Thermo Fisher Scientific likewise touched on its clinical mass spec plans, although much less extensively than AB Sciex. Asked to provide a timeline for obtaining regulatory clearance for the company's mass specs, president and CEO Marc Casper said that he "would expect us to see over the next couple of years an acceleration" in that process.
"Typically in terms of a clearance process, it's around the quality system that you have in place," he said. "Obviously we have a very robust quality system, we have a lot of FDA-cleared products, so it's really about just certifying what the product is and applying for the registration."
Bruker also briefly noted its interest in clinical mass spec, citing "secular megatrends" that would affect its business such as the rise of protein- and metabolite-based diagnostics and MALDI-mass spec-based microbial identification platforms like its MALDI Biotyper.
Quiet Week for Product Releases
AB Sciex also led the way this week in terms of new product releases, at least in terms of those with potential proteomics applications.
The company launched at the meeting its new TripleQuad 4500 System, a mid-range triple quadrupole instrument for routine analyses including protein and peptide identification and quantification. According to the company, the system offers 10 times the sensitivity of comparable mid-range triple quads.
It also launched its new Eksigent ekspert microLC 200 System, which it said delivers improved speed and sensitivity while reducing sample consumption, enabling improved throughput and robustness for assays including peptide quantitation.
Waters this week introduced a new line of chemical reagents and standards for LC and LC-MS. Ranging from "pre-formulated, small molecule, single-component standards to multi-component test mixes to protein digest and glycan standards" the new reagents, Waters said, would greatly reduce "a source of variability, from analysis to analysis, instrument to instrument, and from laboratory to laboratory."
It also launched its new Acquity UPC(2) chromatography system, which it said "expands the boundaries of reversed phase liquid chromatography and of gas chromatography separations," enabling researchers to "routinely separate compounds that are less amendable to analysis by LC and GC."
Bruker's Pittcon product releases focused primarily on the environmental, industrial, and applied markers, but CEO Frank Laukien announced that the company plans to release a new nanoLC system for proteomics research later this year.
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