Hologic HER2DX acquisition

Precision Oncology Consulting  |  Published 5 November 2026

Diagnostic consolidation and regulatory certification are both advancing across precision oncology, shaping how quickly and reliably tests reach European patients. Several recent developments illustrate this: Hologic’s acquisition of the Barcelona-based developer of a HER2-positive breast-cancer prognostic test, a European regulatory certification extending Tempus’ cancer genomic profiling assay’s market access, a next-generation residual-disease test launched in the United States by Abbott without a confirmed European pathway, and a UK regulatory decision that removes a step in post-Brexit device approval. This article reviews each development in turn. Its European market-access implication is stated directly alongside the facts in each section below.

Hologic to Acquire Reveal Genomics, Adding the HER2DX Test

Hologic signed a definitive agreement on 19–20 October to acquire Reveal Genomics, a precision-oncology company based in Barcelona, Spain, whose integrated clinico-genomic tests include HER2DX, a genomic risk-score test used to help tailor treatment decisions for patients with HER2-positive early-stage breast cancer [1]. Hologic described the acquired portfolio as complementary to Breast Cancer Index, its existing test for HR+ disease within the Diagnostic Solutions division, with HER2DX extending its breast cancer genomic testing into the HER2-positive setting [1]. Financial terms were not disclosed, and completion is subject to Spanish regulatory approval and other customary closing conditions, with no closing date given [2].

This Reveal Genomics acquisition by Hologic places HER2DX, a Spain-originated, HER2-positive breast-cancer test, inside a larger US diagnostics company’s existing European commercial and distribution infrastructure, which could broaden the test’s reach beyond what Reveal Genomics could achieve independently. How Hologic integrates HER2DX distribution and support across Reveal’s existing European laboratory relationships remains an open question for clinicians and labs already using the test.

Tempus Receives EU IVDR Certification for Its xR RNA-Sequencing Assay

Tempus announced on 26 October that its xR assay, which sequences RNA to detect gene fusions and splice variants in solid-tumour tissue, has been certified under the EU’s In Vitro Diagnostic Regulation (IVDR) as a Class C device, covering the company’s quality-management system for next-generation-sequencing devices used in cancer genomic profiling [3]. For Tempus, the certification could secure xR’s place in the EU market beyond 2028, the transition deadline for eligible legacy Class C devices under IVDR, giving the company an IVDR-compliant base from which to expand its European commercial presence and support EU clinical trials that require certified testing [3]. The release named no notified body, country-specific launch or reimbursement timeline.

Adding RNA-level fusion testing to a DNA-based cancer genomic profiling workflow catches actionable fusions that DNA-only panels can miss, and this certification keeps that combination compliant in Europe ahead of the 2028 IVDR transition deadline, a step several cancer genomic profiling vendors are taking well ahead of that cliff rather than waiting until it arrives.

Abbott Launches Next-Generation Whole-Genome-Sequencing Oncodetect Test

Abbott launched the next generation of its Oncodetect molecular residual disease (MRD) test on 26 October, moving from whole-exome to whole-genome sequencing and tracking up to 5,000 patient-specific variants, up from 200 in the first-generation assay [4]. The test uses MAESTRO technology, developed at the Broad Institute of MIT and Harvard, which Abbott says enriches tumour DNA from blood by up to roughly 1,000-fold, giving a limit of detection below one part per million and more than 99% analytical specificity under high-end inputs [4]. Validation data include the Beta-CORRECT colorectal cancer study, presented at ESMO Congress 2026 (4426P), which reported a 30% absolute improvement in two-year recurrence sensitivity over the first-generation test at a single post-surgical time point [4].

No CE marking, European availability or EU regulatory timeline was disclosed alongside the launch, and the test, performed by Genomic Health, a US CLIA-certified laboratory within Abbott’s Cancer Diagnostics segment, has not been cleared or approved by the FDA either, leaving it a US-only development for now. Abbott has previously brought diagnostics through European certification on its own timeline: its Cologuard Plus stool-DNA screening test already carries a CE mark, so a precedent exists for Abbott eventually bringing this next-generation Oncodetect test to European testing and reimbursement discussions, even though no such pathway has yet been confirmed.

UK’s MHRA Confirms Indefinite Recognition of CE-Marked Diagnostics

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) confirmed, following a public consultation that drew more than 1,000 responses, that medical devices and in vitro diagnostics already CE-marked for the EU market will continue being accepted in Great Britain without a separate UK-specific approval process, with no fixed end date [5]. Devices certified under the EU’s old Medical Device Directive receive a six-month extension, to 31 December 2028, aligned with the EU’s own Medical Device Regulation transition deadline, and the UK’s own UKCA marking route remains available but is not being made mandatory [5]. The MHRA rejected Proposals 2b and 3 from its consultation, which would have created a separate reliance route based on divergent classification to avoid unnecessary regulatory complexity. Subject to parliamentary approval, the legislative changes will be made before 30 June 2028 [5].

For companies selling CE-marked companion diagnostics and liquid-biopsy tests into the UK, this removes the risk of a UK-specific re-approval requirement stacking on top of EU IVDR compliance, keeping one fewer regulatory track to plan against across both markets.

Concluding remarks

Across these four developments, consolidation, certification and regulatory recognition are each shaping how precision-oncology diagnostics move through Europe, by different routes. Hologic’s acquisition of Reveal Genomics brings a European-developed HER2-positive breast-cancer prognostic test inside a larger commercial network; Tempus’s IVDR certification keeps a genomic profiling assay compliant ahead of the 2028 transition deadline; Abbott’s next-generation Oncodetect test shows how far a US-only launch can still sit from confirmed European availability; and the UK’s CE-mark recognition decision removes one layer of cross-border friction for devices already certified in the EU. HER2-positive breast cancer testing, the subject of the Hologic-Reveal Genomics acquisition described above, sits alongside other biomarker-driven diagnostics discussed in our related article on HER2 – A New Pan-Cancer Biomarker, which examines how HER2 testing is expanding beyond breast cancer into other tumour types.

References

1. Hologic, “Hologic Signs Definitive Agreement to Acquire Reveal Genomics,” BioSpace/Business Wire (19–20 Oct 2026)
2. Fierce Biotech, “Hologic snaps up Reveal Genomics to boost genomic diagnostic reach” (20 Oct 2026)
3. Tempus, “Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling” (26 Oct 2026)
4. Abbott, “Abbott Launches Whole Genome Sequencing Oncodetect Molecular Residual Disease (MRD) Test to Detect Traces of Cancer During and After Treatment,” PR Newswire (26 Oct 2026)
5. Emergo by UL, “Confirmation of Indefinite Recognition of CE-Marked Medical Devices in Great Britain” (28 Oct 2026)