NEW YORK (GenomeWeb) – As part of its overall strategy for sustained growth, Thermo Fisher Scientific has been developing a number of new clinical research and diagnostic products, ranging from US Food and Drug Administration-cleared immunoassays to next-generation sequencing-based panels, and is partnering with others to develop molecular diagnostic kits.
In a conference call yesterday to discuss the company's third quarter earnings, CEO Marc Casper highlighted several of the firm's recent initiatives and product launches in the clinical arena.
Overall, its specialty diagnostics segment — one of Thermo's four business areas — booked $800 million in revenues for the third quarter, 3 percent more than during the year-ago quarter. This growth was due in part to its transplant diagnostics and immunodiagnostics businesses.
This summer, the FDA granted 510(k) clearance for extended use of Thermo's BRAHMS PCT sepsis test, an immunoassay that measures procalcitonin. The test can now be used before a patient is admitted to the intensive care unit, Casper said, whereas it previously was only cleared for use with critically ill patients already in the ICU.
Thermo has licensed the test non-exclusively to both Roche and Biomérieux, and Casper said the company collaborated with its partners on receiving FDA clearance to run the test on their installed instrument bases in the US. "This will significantly expand access to this valuable diagnostic tool," he said.
Roche's BRAHMS PCT test runs on the company's Elecsys cobas e platforms, while Biomérieux's runs on that firm's Vidas instruments. In addition, earlier this year, Thermo announced the launch of a version of the BRAHMS PCT test that it co-developed with Samsung Electronics. That test has received the CE mark for use in Europe but is currently not available in the US.
Also this summer, Casper said, Thermo Fisher received FDA 510(k) clearance for its DRI Hydrocodone assay, which can identify possible opioid abuse, and in May, it obtained clearance for two EliA IgG thyroid tests, autoimmunity tests for the diagnosis of thyroid autoimmune disease.
The DRI Hydrocodone assay, a homogeneous enzyme immunoassay, detects hydrocodone and its metabolites in human urine. According to the company, it can be used in qualitative and semi-quantitative modes and shows good correlation with LC-MS/MS-based test results.
The new EliA IgG tests detect anti-Thyroglobulin and anti-Thyrioid Peroxidase antibodies, respectively, in serum or plasma and run on the Phadia 250/2500/5000 systems. According to the company, more than 98 percent of thyroiditis patients have autoantibodies to thyroglobulin, thyroid peroxidase, or both.
In addition to its immunoassay business, Thermo is also "seeing nice momentum in customer adoption of our sequencers," Casper said, which include the S5 and S5 XL it released about a year ago, and it launched several new clinical research assays during the third quarter. Its Oncomine cancer panels now include an Oncomine Lung cfDNA Assay and the Oncomine BRCA Research Assay for BRCA1 and 2.
Thermo also launched an update to its cloud-based Thermo Scientific LabLink xL 2.0 quality assurance software this summer, which can be used to monitor instrument performance on a daily basis and enables clinical chemistry and manufacturing labs to compare data with other labs.
In terms of partnerships in the clinical arena, Casper pointed out Thermo Fisher's recent alliance with Health BioMed (HBM) in Ningbo, China, which was announced in July. The companies are collaborating to develop molecular diagnostic kits for infectious disease and pharmacogenomics screening for the Chinese market. HBM will develop the kits on Thermo's Applied Biosystems 3500Dx capillary electrophoresis platform and submit them to the China Food and Drug Administration after validation.
"This is another great example of our ability to support precision medicine initiatives that are part of China's five-year plan," Casper said.