COPENHAGEN – Thermo Fisher Scientific this week launched the first of 37 CE-IVD-marked real-time PCR assay kits, mostly for infectious diseases, that it plans to roll out this year, providing users of its QuantStudio Dx series of instruments with a menu of company-branded test kits for the first time.
At the European Congress of Clinical Microbiology and Infectious Diseases held here, Thermo Fisher showcased assay kits for human papillomavirus and herpes simplex virus screening, alongside its QuantStudio 5 Dx (QS5 Dx) real-time PCR system.
Those two assays are currently available in all countries that recognize CE marking for use with the CE-IVD-marked QS5 Dx. That diagnostic testing platform is also compliant under the EU's new In Vitro Medical Devices Regulation (IVDR) framework, but the assay kits are not yet.
Thermo Fisher plans to launch the rest of the kits in phases throughout 2023, starting with additional assays for sexually transmitted and blood-borne infections including chlamydia, gonorrhea, and HIV, followed by tests for respiratory tract infections, infections in transplant and immunocompromised patients, and hepatitis. By midyear, the company said, assays will also be available for thrombotic mutations and vector-borne diseases.
The new assays are all CE-IVD marked with a "path to" IVDR compliance, Stephane Santos, general manager of clinical testing solutions at Thermo Fisher Scientific, said at ECCMID.
Santos, whose background includes executive roles related to in vitro diagnostics at Roche and BioMérieux, most recently managed Thermo Fisher's immunoassay/antibody-based global toxicology and therapeutic drug monitoring business for more than three years before joining clinical testing solutions late last summer "with the ambition of bringing Thermo Fisher into the IVD regulated space with clinical solutions," he said.
Santos noted that Thermo Fisher has traditionally played mostly in the research-use-only market. However, like many companies, it quickly developed and received US Food and Drug Administration Emergency Use Authorization for a COVID-19 molecular test during the pandemic, which sparked the company's foray into regulated IVD tests, he said.
Thermo Fisher's relatively rapid entry into the molecular IVD space was made possible through a partnership it struck last year with GeneProof, a Brno, Czech Republic-based IVD manufacturer that last April merged with IVD firm American Laboratory Products Company, better knowns as ALPCO. At the time of the merger, GeneProof was the largest producer of PCR reagents in the Czech Republic and had a portfolio of more than 70 CE-marked molecular diagnostic tests.
Thermo Fisher started its partnership with GeneProof sometime after this merger, Santos said, but did not publicize it until this week when it announced the new assay portfolio. Santos said that under an in-licensing agreement, Thermo Fisher is marketing the tests with GeneProof as the manufacturer of record. As such, all of the assays will be branded as Applied Biosystems TaqPath Menu/GeneProof PCR Kits.
The partnership was a natural fit, as GeneProof already had the test portfolio and Thermo Fisher had a large installed base of QuantStudio platforms. Santos declined to provide a number for the installed base but described it as "massive."
Unlike other IVD players, Thermo Fisher was able to continuously manufacture QuantStudio instruments during the COVID pandemic, he noted. As COVID-19 testing waned, QuantStudio customers were asking the company about additional tests they could run on the machines.
Mostly, the answer was laboratory-developed tests, often with reagents from Thermo Fisher but sometimes from other companies. Now, Thermo Fisher will be able to offer its own comprehensive test menu, at least in countries recognizing CE marking. The QS5 Dx also runs the Applied Biosystems Diomni software, which provides labs with a browser-based application connected to multiple instruments and enables users to plan extractions, run qPCR tests, and review interpretive results, for instance, according to the company's website.
Besides the QS5 Dx, Thermo Fisher also markets the QuantStudio 7 Pro Dx (QS7 Pro Dx) platform, which differs mainly in throughput — it can run 96-well and 384-well plates whereas the QS5 Dx can only run 96-well plates.
Last September, the QS7 Pro Dx also gained IVDR compliance, as well as Class II medical device status with the US Food and Drug Administration. Around the same time, it also became compatible with the Diomni software.
Thermo Fisher stressed, however, that the TaqPath Menu/GeneProof assays are not yet validated on the QS7 Pro Dx. Santos did not provide a timeline for when that might happen but suggested that different kits will be made available on the platform as they gain IVDR compliance.
Santos also declined at this time to comment on Thermo Fisher's plans for pursuing FDA clearance for the TaqPath Menu/GeneProof assays.