SAGA Diagnostics AB - Pioneer in Ultrasensitive Liquid Biopsy and Molecular Residual Disease Detecti

Company Profile (Updated April 2026)

SAGA Diagnostics AB is a Swedish-American precision oncology diagnostics company dedicated to revolutionizing cancer care through ultrasensitive molecular detection technologies. Founded in 2016 as a spin-out from Lund University by Dr. Lao Saal and Anthony George, the company maintains dual headquarters: its Swedish headquarters at Medicon Village, Scheelevägen 2, SE-223 81 Lund, Sweden, and its U.S. headquarters and CLIA-certified laboratory in Morrisville, North Carolina (Research Triangle Park). SAGA Diagnostics combines world-class genomic expertise with proprietary digital PCR and next-generation sequencing technologies to detect circulating tumor DNA (ctDNA) at unprecedented sensitivity, enabling clinicians and researchers to intercept cancer at its earliest and most treatAble stages.

Development History:

- 2016: SAGA Diagnostics founded in Lund, Sweden, by Dr. Lao Saal and Anthony George as a spin-out from the Translational Oncogenomics Laboratory at Lund University

- 2017: Joined the NOME Nordic Mentor Network for Entrepreneurs, gaining valUABle U.S. market insights and investor introductions

- 2018: Completed seed round financing; continued development of SAGAsafe® digital PCR platform and ultrasensitive mutation detection assays

- 2019: Completed early-stage venture financing; expanded professional workforce and laboratory capabilities

- 2020: Launched SAGAsafe® CE-IVD marked assays, including the EGFR T790M mutation detection kit; validated technology in hundreds of patient samples demonstrating detection of cancer recurrence up to three years (average 11 months) prior to clinical symptoms

- 2021: Closed Series A2 funding of $12.6 million; continued commercial expansion and platform development

- 2023: Established U.S. CLIA-certified laboratory in Morrisville, North Carolina (Research Triangle Park); expanded team to approximately 46 employees

- 2025: ACHieved U.S. commercial launch of Pathlight™ for early-stage breast cancer at the ASCO Annual Meeting (June); on July 30, secured Medicare coverage via MolDX for stage II-III breast cancer recurrence monitoring across all subtypes for up to six years; presented data at SABCS 2025 (December) confirming ultra-sensitive performance across all breast cancer subtypes; presented at the Jefferies Global Healthcare Conference in London

- 2026: On January 12, launched Pathlight™ MRD test for colorectal cancer; on January 8–10, presented real-world CITCCA study data at ASCO GI 2026 in San Francisco; on April 17–22, presented ovarian and metastatic breast cancer data at AACR 2026 in San Diego; on April 16, announced acquisition by Roche for up to $595 million through Foundation Medicine

Core Mission: To intercept cancer early when patients are most treatable and curable by providing ultrasensitive liquid biopsy and tissue-based diagnostic solutions that enable precise treatment selection, accurate treatment response monitoring, and early detection of molecular residual disease and cancer recurrence.

Technology Platform ＆ Product Portfolio

Pathlight™ - Tumor-Informed MRD Platform

Pathlight™ is SAGA Diagnostics' flagship personalized, tumor-informed molecular residual disease (MRD) platform. It uses a proprietary combination of whole genome sequencing (WGS) and digital PCR to identify and track large-scale genomic changes known as structural variants (SVs). By optimizing for SVs rather than single nucleotide variants, Pathlight achieves ultra-sensitive MRD detection down to sub 1 ppm (＜0.0001% mutant allele frequency) with 100% analytical specificity—100 to 1,000 times more sensitive than conventional PCR and next-generation sequencing methods. Because SVs are stable, unique to each patient and tumor, and often amplified in the tumor, the platform produces more ctDNA fragments for detection and reduces false positives.

Clinical Performance:

- 100% sensitivity and 100% specificity in detecting early breast cancer recurrence in the published TRACER study

- Provides a 13.7-month head start to treatment compared to standard clinical detection methods (imaging)

- 96% baseline detection rate across all subtypes in stage I-III breast cancer, including 94% in ER+ disease

- ＞99.9% plasma sample pass rate in published work; successful fingerprint generation in 94% of patients

- Demonstrated strong clinical performance in breast cancer, colorectal cancer, ovarian cancer, and metastatic breast cancer

Commercial Status:

- Available for commercial use in the U.S. for patients with early-stage breast cancer and colorectal cancer

- Medicare-covered via Palmetto GBA MolDX for stage II-III breast cancer recurrence monitoring across all subtypes (HR+/HER2-, HER2+, TNBC) for up to six years in the surveillance setting

- Actively used in clinical studies by multiple top 10 pharmaceutical companies and leADINg academic institutions and national cancer centers

- Plans for international launch following Roche acquisition and integration with Foundation Medicine

SAGAsafe® - Cancer Mutation Detection

SAGAsafe® is a proprietary digital PCR-based cancer mutation detection platform employing enhanced patented chemistry that eliminates detection noise seen with standard methods. It enables significantly improved sensitivity and specificity for detecting actionable mutations in tissue biopsies and liquid biopsies.

Key Features:

- Limit of Detection: 0.001% mutant allele frequency (MAF) with 95% confidence

- Sample Types: Works on any bodily fluid (blood, plasma, urine) and tissue samples

- Turnaround Time: One day from sample to result for standard assays

- Multiplexing: Capable of including a range of mutations on the same sample

- Custom Assays: New custom assays can be developed within 4–6 weeks

- Regulatory Status: CE-IVD marked for in vitro diagnostic use in the European Union (e.g., SAGAsafe® EGFR T790M kit)

Laboratory Services

SAGA Diagnostics operates a CLIA-certified laboratory in Morrisville, North Carolina, providing comprehensive molecular genetic testing services to:

- Pharmaceutical and biotechnology companies: Companion diagnostics, patient stratification, and treatment response monitoring for clinical trials

- Healthcare providers: Clinical testing for MRD detection, recurrence monitoring, and actionable mutation identification

- Academic institutions: Research collaboration and access to ultrasensitive genomic analysis tools

Clinical Evidence ＆ Key Studies

Published Performance Data

- TRACER Study (Early Breast Cancer): Pathlight™ demonstrated 100% sensitivity and 100% specificity in detecting early breast cancer recurrence, providing a 13.7-month lead time over clinical symptom detection; 96% baseline detection across all stage I-III subtypes including 94% in ER+ disease; published in Clinical Cancer Research (January 2025)

- CITCCA Study (Colorectal Cancer) - ASCO GI 2026: Retrospective analysis of 377 patients with stage I–III colorectal cancer (60% colon, 40% rectal) across seven Swedish centers. ctDNA-positive patients post-treatment experienced significantly higher recurrence rates with an overall hazard ratio of 38.5 (33.8 for colon; 93.5 for rectal). Three-year recurrence-free interval (RFI) was ~30% for ctDNA-positive patients versus ~90% for ctDNA-negative patients. 42.5% of ctDNA-positive patients at the 4-6 week post-surgery landmark had ctDNA levels in the ultrasensitive range (＜100 ppm), detectable only by ultra-sensitive assays.

- AACR 2026 - Metastatic Breast Cancer (mBC): In collaboration with University Health Network (UHN) Canada (Drs. David Cescon and Mitchell Elliott), SV-based ctDNA monitoring in mBC achieved a 77% detection rate (294/380), with nearly one-third identified in the ultrasensitive range. Pathlight proved a powerful predictor of outcomes: undetectable ctDNA correlated with exceptional therapy responses including prolonged disease stability and complete clinical response. Rising ctDNA levels preceded radiologic signs of progression across multiple lines of therapy.

- AACR 2026 - Ovarian Cancer (HGSOC): In collaboration with the Medical University of Vienna and LMU Munich, retrospective analysis of 84 patients with advanced high-grade serous ovarian cancer showed 94% baseline detection and 85% MRD persistence postoperatively. In patients with patHological complete tumor resection, ctDNA clearance at the first chemotherapy cycle (20%) and sixth cycle (70%) was associated with significantly lower recurrence risk. ctDNA persistence at cycle 6 was a powerful independent prognostic marker: ctDNA-positive patients faced a median time to clinical recurrence of just 10.7 months compared to 21.3 months for those who cleared ctDNA. CA-125 levels failed to significantly predict recurrence at key milestones.

Financial Performance ＆ Funding History

Funding Rounds

- Total Raised: Approximately $18 million across multiple rounds and grants

- Series A2 (June 2021): $12.6 million

- Grants ＆ Early Stage VC (2016–2020): Multiple grants and venture rounds including support from Lund University, the Swedish innovation system, and international investors

Acquisition Terms (April 2026)

- Acquisition Price: Up to $595 million (approximately €504 million), inclusive of commercial and regulatory milestone payments

- Acquirer: Roche (via Foundation Medicine, an independent affiliate)

- Expected Closing: Q3 2026, subject to customary regulatory approvals

- Previous Revenue Guidance: SAGA had previously guided to sales targets of approximately $150 million by 2028

- Strategic Rationale: Foundation Medicine CEO Dan Malarek stated: "Pathlight strengthens our comprehensive portfolio of diagnostic solutions and reinforces our commitment to transforming cancer care throughout a patient's experience. MRD is one of the fastest-growing areas within diagnostics and this technology provides us with a clinically available ultra-sensitive offering."

Key Investors

- Fåhraeus Startup and Growth Fund

- I Love Lund (Family Office)

- Jinderman ＆ Partners

- Northislet

- Rose Ventures

- Hadean Ventures

- LU Ventures (Lund University venture arm)

Company Overview

Corporate Information

Company Name: SAGA Diagnostics AB

Founded: 2016

Swedish Headquarters: Medicon Village, Scheelevägen 2, SE-223 81 Lund, Sweden

U.S. Headquarters ＆ CLIA Laboratory: Morrisville, North Carolina, USA (Research Triangle Park)

Company Type: Private Venture-Backed Company (Pending Acquisition)

Industry: Medical Diagnostics / Precision Oncology / Liquid Biopsy

Employees: Approximately 46

Phone: +46 (0)733 01 7242

Email: info@sagadiagnostics.com

Leadership Team (2025–2026)

Chief Executive Officer: Peter Collins

- Confirmed as CEO in April 2026 per PR Newswire and Memel Biotech verification; leading the company through commercial launch and Roche acquisition

Founder ＆ Chief Operating Officer: Dr. Lao Saal

- Co-founded SAGA in 2016 based on leading research from Lund University's Translational Oncogenomics Laboratory; driving force behind the company's scientific vision

Co-Founder ＆ CTO: Anthony George

- Co-founded SAGA with Dr. Saal; leads technology development and platform innovation

Chief Clinical Officer: Wendy Levin, MD, MS

- Oversees clinical strategy, medical evidence generation, and regulatory affairs; quoted in AACR 2026 communications on clinical utility of SV-based MRD monitoring

Executive Chairman (Former): Roopom Banerjee

- Previously served as Executive Chairman; quoted in July 2025 Medicare coverage announcement

Vice President of Medical Affairs: Jennifer B. Permuth-Wey, PhD, MS

Director of Client Partnerships: Johanna Asklin

Director of Market Access: Annina Hube

Patient Support ＆ Billing

Pathlight Patient Support Program

SAGA Diagnostics operates a dedicated patient support program to ensure financial constraints do not limit access to MRD testing:

- Medicare Coverage: Pathlight is covered by Medicare for eligible patients when ordered by a qualified healthcare provider for covered cancer indications; typically no out-of-pocket expenses for qualifying Medicare beneficiaries

- Financial Assistance: Full or partial financial assistance based on household income and financial hardship for uninsured and underinsured patients

- Insurance Appeals Support: Billing team assists with insurance appeals for denied claims

- Interest-Free Payment Plans: Available for eligible balances

- Billing Support Line: 1-855-767-1009

- Toll Free: 1-866-226-2611

- Email: patientservices@sagadiagnostics.com

- Hours: Monday – Friday, 9 AM – 5 PM EST

Strategic Partnerships ＆ Collaborations

Pharmaceutical ＆ Biotech Partnerships

SAGA Diagnostics partners with pharmaceutical and biotechnology companies to support early through late-stage cancer development programs across a range of tumor types. These partnerships leverage Pathlight™ and SAGAsafe® for:

- Patient stratification and companion diagnostic development

- Treatment response monitoring in clinical trials

- Molecular residual disease endpoint validation

- Early detection of resistance mutations (e.g., EGFR T790M in lung cancer)

Academic Collaborations

- Lund University: Ongoing research collaboration with the Translational Oncogenomics Laboratory

- Karolinska Institutet: Collaboration on the CITCCA colorectal cancer study presented at ASCO GI 2026

- University Health Network (UHN) Canada: Collaboration with Drs. David Cescon and Mitchell Elliott on metastatic breast cancer research presented at AACR 2026

- Medical University of Vienna ＆ LMU Munich: Collaboration on high-grade serous ovarian cancer research presented at AACR 2026

- Preeminent Academic Institutions: Pathlight™ is being used successfully in clinical studies at leading academic and national cancer centers

Global Market ＆ Competitive Landscape

Target Markets

United States: Primary commercial market with CLIA laboratory operations in Morrisville, NC, Medicare coverage for breast cancer, commercial launch for colorectal cancer, and active pharmaceutical partnerships; Foundation Medicine integration will further expand U.S. commercial scale

Europe: Headquartered in Lund, Sweden with CE-IVD marked SAGAsafe products; strong ties to Nordic and European academic medical centers; Roche acquisition will accelerate European commercialization

Global Expansion: Roche acquisition will enable worldwide distribution through Foundation Medicine's global network and Roche's AXELIOS/Digital LightCycler decentralized platforms

Primary Competitors

- Guardant Health (USA): Leading liquid biopsy company with Guardant360 and Guardant Reveal MRD tests

- Natera (USA): Signatera tumor-informed MRD test for solid tumors

- Inivata (UK/USA): RaDaR tumor-informed MRD platform

- Foundation Medicine (USA): Comprehensive genomic profiling and liquid biopsy (now SAGA's acquiring parent)

- Tempus (USA): AI-enabled precision medicine and molecular diagnostics

- TumorTrace / Exact Sciences: Competing MRD and early detection platforms

Competitive Advantages

- Unmatched Sensitivity: Sub 1 ppm detection (＜0.0001% MAF) with 100% analytical specificity—100 to 1,000-fold more sensitive than competing PCR and NGS methods

- Structural Variant Optimization: Unique focus on large-scale structural variants rather than single nucleotide variants, enabling more robust MRD tracking, higher specificity, and reduced false positives

- Tumor-Informed Personalization: Pathlight™ is personalized to each patient's tumor profile, maximizing specificity and clinical relevance; generates successful fingerprints in 94% of patients

- Dual-Technology Integration: Proprietary combination of WGS and digital PCR delivers both comprehensive discovery and ultrasensitive monitoring

- Clinical Validation: 100% sensitivity and 100% specificity in early breast cancer (TRACER study); 13.7-month lead time; Medicare coverage validates clinical utility

- Multi-Cancer Applicability: Demonstrated strong performance in breast, colorectal, ovarian, and metastatic breast cancers

- Roche Scale: Acquisition by Roche/ Foundation Medicine provides access to global commercial infrastructure, regulatory expertise, AXELIOS sequencing platform, Digital LightCycler PCR, and decentralized platform development

2026 Outlook ＆ Strategic Priorities

Near-Term Objectives

- Acquisition Closing: Complete regulatory approvals and close Roche acquisition by Q3 2026

- Foundation Medicine Integration: Integrate Pathlight™ into Foundation Medicine's comprehensive diagnostic portfolio and leverage Roche's AXELIOS sequencing and Digital LightCycler PCR platforms

- Decentralized MRD Solution: Collaborate with Roche to develop a decentralized MRD testing solution enabling patient access in healthcare settings worldwide

- Tumor Type Expansion: Expand Pathlight™ applicability beyond breast and colorectal cancer to additional tumor types and indications, including ovarian and metastatic settings

- International Launch: Prepare for global commercial launch beyond the U.S. through Roche's international distribution network

Contact Information

Corporate Headquarters

Swedish Address: Medicon Village, Scheelevägen 2, SE-223 81 Lund, Sweden
   Phone: +46 (0)733 01 7242

U.S. Headquarters ＆ CLIA Laboratory

Address: Morrisville, North Carolina, USA (Research Triangle Park)

Patient ＆ Billing Services

Billing Support: 1-855-767-1009
   Toll Free: 1-866-226-2611
   Email: patientservices@sagadiagnostics.com

Media ＆ General Inquiries

Website: www.sagadiagnostics.com
   Media Contact: media@sagadiagnostics.com

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