For those that might be interested we have recentl...
# regulatoryj
Joep de Ligt
08/12/2026, 10:44 AMFor those that might be interested we have recently successfully obtained IVDR accreditation for our cancer WGS analytics 'diagnostic product'. Under the hood the software is 90% #C04CQ1LK7U1 with additional safe guards, orchestration and verifications on top. If this work group is interested in what we encountered and the choices we made happy to connect you with the people that did the actual work. hartwigmedicalfoundation.nl/…/hartwig-receives-ce-certification-for-hartwig-medical-oncoact-the-first-complete-ivdr-certified-whole-genome-cancer-diagnostics-solution
important note, this is work 3 years in the making!
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Ben
08/12/2026, 11:57 AMChapeau, @Joep de Ligt! That's quite an achievement. It seems like OncoAct is provided as a service to physicians, i. e. run as a medical device exclusively inside the health institution Hartwig Foundation, is that correct?
It seems like certain human intervention is built into the medical device: "This report was generated automatically and checked by a trained Clinical Molecular Biologist in Pathology (KMBP)." This prevents it probably from being marketed as a stand-alone medical device?
Did you have to limit compatibility statements to certain instruments and reference genomes?
(apologies for my very specific questions, but I have always been impressed by the Hartwig Foundation's projects)
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Joep de Ligt
08/12/2026, 12:27 PMHi @Ben no worries this is why I offered to comment, and yes correct for now it's registered with a fairly narrow scope, we're looking into offering the software part as a SAAS with accreditation in the future but for now it's indeed only when embedded within our clinical quality system
Joep de Ligt
08/12/2026, 12:29 PMFor now there is indeed a manual check (because of it's intended clinical use) that takes the clinician between 2-5 minutes per report to ensure nothing strange happened in the reporting (we have observed ±0.75% corrections in the ±8000 we have done to date)
Joep de Ligt
08/12/2026, 12:30 PMWe have not limited it to sequencing platform on the IVDR side but the clinical side is for now only validated for Illumina (X and 6000), the reference genome is a resource and we have validated it for use with hg19 and GRCh38
Joep de Ligt
08/12/2026, 12:31 PMdoes that cover everything you wanted to know?
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Ben
08/12/2026, 1:04 PMPerfect, thanks! You see me in awe that you pulled this off.
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Joep de Ligt
08/12/2026, 1:42 PMCheers, it was a big team effort and we hope it will further add to the trust and uptake of the #C04CQ1LK7U1 pipeline
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Alex Peltzer
08/13/2026, 8:58 PMSuper interested ☝️😎
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Joep de Ligt
08/14/2026, 8:04 AMhoi @Alex Peltzer anything in particular you'de like to know more about (trying to see if we can get a group together around 1 or 2 topics to set up a 'ask my anything' type of session)
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Alex Peltzer
08/18/2026, 7:48 PMIm on annual leave at the moment - will text you once I'm back here 👍😎
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