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At ESHG, Thermo Fisher Official Predicts IVDR Will Push Labs to Replace LDTs With Commercial Kits

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NEW YORK — Europe's new In Vitro Diagnostic Regulation (IVDR) is not only remaking the way that manufacturers obtain regulatory compliance for their test kits, it may also reshape the way that laboratories use in-house assays for diagnostics.

Stipulations in the new regulation, which began to apply last month, call for labs to either adopt tests and platforms that hold a CE-IVDR mark, or to justify to local authorities their reasons for using an in-house assay instead. That factor plus others could cause more labs to switch to commercial platforms, according to Anna Sadio, manager of regulatory affairs for Europe, the Middle East, and Asia (EMEA) at Thermo Fisher Scientific.

"With the use of in-house and research-use-only assays severely limited, labs will be strongly pushed to use CE-IVD marked devices," Sadio said during a company satellite presentation at the European Society of Human Genetics meeting held in Vienna and virtually this week.

Such a shift away from in-house devices, also called laboratory-developed tests or homebrews, could have a far-reaching impact on the European diagnostics market, Sadio noted. While a 2021 BioMed Alliance survey found that roughly half of the tests run by European labs today are in-house assays (IHAs), Sadio noted that the majority of genetic tests are developed in house, while labs tend to buy and use commercial, CE-IVD marked blood tests or clinical chemistry assays.

Most genetic tests, Sadio said, were self-certified under 1998's In Vitro Diagnostic Directive, which remained in force until this year. They now fall under Class C of the IVDR, meaning they will require review by a notified body and certification. In January, European regulators agreed to extend timelines for certain classes of products that already hold CE-IVD marks under the IVDD. That means that Class C devices that already held a CE-IVD mark prior to the May 26, 2022, date of application of the IVDR, do not need to obtain a new certificate under the IVDR until May 2027.

However, Sadio said, all of Thermo Fisher Scientific's assays are paired with instruments, which are considered to be Class A devices, and already need to meet IVDR guidelines, albeit via a self-certification process. Thermo Fisher Scientific announced earlier this month that its Applied Biosystems QuantStudio 5 Dx Real-Time PCR System already is compliant with the IVDR. She added that the system retains a separate assay development mode, so that users can develop in-house assays focused on rare conditions and diseases for which commercial kits do not yet exist.

It appears Thermo Fisher will likely seek CE-IVDR certificates for other instrument platforms. In a Q&A session following Sadio's talk, Alan Livingston, Thermo Fisher Scientific's EMEA regional marketing development manager, commented that "many of [the company's] instruments are going through the certification process," and confirmed, when asked, that its high-throughput GeneTitan Multi-Channel Instrument would be one such product.

During her talk, Sadio walked through the timelines around the IVDR that most affect European labs. She said that European labs are already expected to be compliant with the general safety requirements of the IVDR. By May 2024, they must also show they have appropriate quality management systems in place, such as the ISO 15189 standard, as well as manufacturing process accreditations. By May 2028, they must also be able to justify to local authorities their use of in-house assays over commercially available tests.

While that deadline is six years off, Sadio said that labs need to develop their IVDR strategies by assessing inventories and deciding on what to do if commercial kits do exist. This might include making decisions about what instruments to invest in, in order to move to a commercial system.

"Labs need to think about complying with the first wave of requirements now," said Sadio. "Do a gap analysis, don't reinvent the wheel, have a look at the processes and documentation you already have, and try to adapt," she said. She reiterated that the market may see a decreased demand for RUO products and increased demand for CE-IVDR marked products because of this part of the regulation.

Those who opt to stick with their in-house assays "have to be ready to defend this," said Sadio.

As other observers have noted, the implementation of the IVDR has been challenging. A lack of capacity within designated notified bodies to handle the volume of submissions, compounded by the pressure the COVID-19 pandemic put on regulators, manufacturers, and labs alike, led to the extended transition periods announced in January, and continue to present issues in the segment.

Sadio noted that clinical labs have not had time to prepare for the IVDR because of the pandemic, while infrastructure and guidelines in Europe are still being built to support the regulation. She said, for instance, that specifications covering Class D devices have not yet been published. The IVDR also calls for the establishment of EU reference labs to ensure the compliance of IVDs with the regulation. Sadio said that such labs have not yet been designated.

For its part, Thermo Fisher offers a variety of material on its website for those transitioning to the IVDR.

The regulatory compliance of a product may indeed be increasingly weighing on users. During the workshop, Miguel Milán, director of prenatal genetic diagnostics at Igenomix, a medical testing laboratory based in Valencia, Spain, said that when his lab was looking to adopt a platform for chromosomal microarray analysis last year, most offerings on the market were for research use only.

He said that Igenomix opted to acquire Thermo Fisher Scientific's GeneChip System 3000Dx, which already carries a CE-IVD mark, because it was compliant with the IVDD. According to Milán, Igenomix runs the company's CytoScan Dx Assay Kit on the system, but because the system can also support research-use-only assays, it can be used for in-house tests.

He said there are still conditions and diseases for which Igenomix needs to develop its own assays, a "costly and time-consuming" process. Being able to run both on the same system was seen as a reason to invest in the platform. "We can run all the experiments we want on the same instrument," he said. "This was important for us."

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