Discovery Life Sciences Launches IVDR-Compliant Luminos® Comprehensive with 7-to-10-Day Turnaround for EU Oncology Trials

First offering in Discovery Life Sciences' new Luminos^® clinical genomics platform delivers 7-to-10-day turnaround from in-house validation at the company's Kassel, Germany facility under Health Institution status; commercially available ahead of ASCO 2026.

HUNTSVILLE, Ala. and KASSEL, Germany, May 20, 2026 /PRNewswire/ -- Discovery Life Sciences today launched Luminos^® Comprehensive, a 164-gene pan-tumor comprehensive genomic profiling (CGP) panel validated on FFPE tissue as an IVDR-compliant laboratory-developed test and deployed in-house at the company's Kassel, Germany facility under Health Institution status per Article 5(5) of the IVDR. Results are delivered in 7 to 10 business days, and the panel is commercially available now.

Pharma sponsors and CROs running oncology trials at European sites have been working around the same problem for two years: the EU In Vitro Diagnostic Regulation requires IVDR-compliant genomic testing for prospective clinical use, but few laboratories can actually deliver it in-house. Most reference labs either cannot claim Health Institution status under Article 5(5), lack a validated in-house panel, or take three to four weeks to return results, timelines that directly delay enrollment and compress trial schedules that are already under pressure.

Luminos® Comprehensive was built for that gap. The panel supports enrollment screening, biomarker stratification, and prospective EU clinical use without third-party reference lab routing or performance-study overhead.

"We hear the same conversation from sponsors and CROs constantly: they need IVDR-compliant prospective testing, but a performance study adds six months to study startup. That doesn't work when enrollment windows are measured in weeks and patient survival is measured in months."

Scott Reid, VP and Global Head of Companion Diagnostics, Discovery Life Sciences

The Compliance Gap Luminos Was Built to Close and Why It Matters Beyond the EU

Deploying precision genomics in EU oncology trials has remained a challenge: IVDR compliance for novel diagnostic devices typically requires sponsors to file complex regulatory submissions, and the addition of a performance study can extend clinical startup by six months or more relative to North America. Most European reference labs offering NGS services either run targeted panels rather than broad CGP, quote 20-to-30-day turnaround, or both, and many Health Institutions lack the project management, data, and logistics capabilities that CROs require. Discovery Life Sciences Kassel is one of the few EU service laboratories that qualifies under the Article 5(5) Health Institution exemption, allowing in-house deployment of novel devices without performance-study overhead. The Kassel genomic operation was purpose-built for IVDR HI status from the start, not retrofitted from a research workflow.

The relevance is not EU-only. IVDR compliance applies to any sponsor enrolling patients at EU trial sites regardless of where the sponsoring company is headquartered — a US-based biotech running a Phase II with sites in Germany and the UK has the same IVDR exposure as a European sponsor. Data sovereignty requirements in the EU mean sponsors increasingly need in-EU genomic data processing to satisfy site-level and country-level requirements, and the Kassel facility addresses both. The 7-to-10-day turnaround is competitive regardless of geography: in enrollment-screening contexts, the speed of genomic data return is a direct variable in site activation, per-patient cycle time, and enrollment velocity. At the scale of a multi-site trial, the difference between a 7-day result and a 21-day result translates into tangible cost and timeline impact.

"Sponsors running EU oncology trials need genomic testing they can rely on: IVDR-compliant, in-house, and fast enough to keep enrollment on schedule. That's what we built Luminos to deliver."

Greg Herrema, Chief Executive Officer, Discovery Life Sciences

What the Panel Covers and Why It Matters

The Luminos® Comprehensive panel covers 164 genes across actionable oncogenes, tumor suppressor genes, DNA damage repair pathways, and emerging therapeutic targets. Established biomarkers (EGFR, KRAS, BRAF, PIK3CA, HER2, TP53) sit alongside less-charted targets relevant to next-generation TKI and small-molecule programs, including KEAP1/NFE2L2, ATM/CHEK2, the MLH1/MSH2 mismatch-repair set, and FGFR1-3. The full gene list and pathway coverage are detailed in the technical summary.

For sponsors whose compounds target pathways where panel gaps have historically meant supplemental testing or a secondary assay, this eliminates a logistical and budget friction point at the enrollment stage.

Pricing is structured on a straightforward per-sample model with no complex tiering. Sponsors and CROs can request a quote at [email protected].

Luminos^® Liquid: Liquid Biopsy Coming Fall 2026

Luminos^® Comprehensive is the first product in a platform Discovery Life Sciences is building for the full specimen lifecycle of oncology trial genomics. Luminos^® Liquid, a cfDNA/cfRNA liquid biopsy panel validated as an IVDR-compliant LDT under Health Institution status, is in final validation at Kassel and expected to launch in Fall 2026, bringing the same compliance posture to a specimen type where most EU providers still require a performance study.

Discovery Life Sciences will be meeting with pharma sponsors and CROs at its hospitality suite at the ASCO Annual Meeting in Chicago, May 29 through June 2. Pre-qualified meeting requests can be booked through the Discovery Life Sciences ASCO 2026 event page. Technical specifications, the full 164-gene list, validation performance, sample requirements, and bioinformatics details for Luminos® Comprehensive are available in the Luminos® Comprehensive technical summary. Inquiries can also be directed to [email protected].

About Discovery Life Sciences

Discovery Life Sciences is a global leader in biospecimens and specialty laboratory services supporting the discovery, development, and clinical advancement of therapeutics and diagnostics. The company partners with 1,150+ biopharma customers, including all top 25 pharmaceutical companies and leading CDx IVD kit manufacturers, and has completed 40+ IVDR projects under Health Institution status. Discovery's portfolio spans human biospecimens and cellular starting material, hepatic science and in vitro ADME, genomics, proteomics, cell biology, and molecular pathology, supporting partners from research through clinical trials. For more information, visit dls.com

Media contact: Todd Poley | Discovery Life Sciences | [email protected] 

SOURCE Discovery Life Sciences