On May 22, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported publication of three Versamune HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting website (Press release, PDS Biotechnology, MAY 22, 2025, View Source [SID1234653313]). These abstracts summarize Versamune HPV (PDS0101) studies to be presented during the Head and Neck Cancer Poster Session taking place May 30-June 3, 2025, in Chicago, Illinois.

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Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech stated, "We continue to be excited about the strength and durability of the VERSATILE-002 data showing the longest survival reported to date in 1L recurrent/metastatic (r/m) head and neck cancer (HNSCC). These results further strengthen our confidence in the ongoing VERSATILE-003 trial, which is the only registrational trial for the rapidly growing population of patients with HPV16-positive r/m HNSCC. Based on our estimates1, HPV16-positive patients are as likely to progress to recurrent and/or metastatic stage as HPV-negative patients, and HPV16-positive patients currently comprise 40-60% of patients in the ICI-naïve r/m HNSCC population in the US."

VERSATILE-002: Overall Survival of HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients Treated with T Cell Stimulating Immunotherapy PDS0101 and Pembrolizumab (Abstract #6037) – Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

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Enrollment in the trial (n=53) is complete; 23 patients (including 3 still on treatment) continue to be followed for survival. No new safety signals have emerged

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Survival Results:

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39.3 months mOS in patients with CPS ≥ 20 (95% Confidence interval, lower limit of 18.4 months, upper limit net yet estimable (NE); published mOS for pembrolizumab is approximately 15 months

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30.0 months mOS (95% CI 23.9, NE) in patients with CPS ≥ 1; published result for pembrolizumab is approximately 12 months

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29.5 months mOS (95% CI 15.3, NE) in patients with CPS 1-19; published result for pembrolizumab is approximately 10 months

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Median follow up of 18.4 months (range 0.2-42.7 months) represents one of the most extended follow-up periods to date of subjects receiving a therapy for HPV16-positive r/m HNSCC.

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Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 Phase 2 clinical trial, will present the poster.

VERSATILE-003: A Phase 3, Randomized, Open-label Trial of PDS0101 and Pembrolizumab compared with Pembrolizumab for First-Line Treatment of Patients with HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma" (Abstract #TPS6111) – Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

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Highlights study objectives and design of the ongoing VERSATILE-003 (NCT06790966) trial

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Median overall survival is primary endpoint – 2 interim readouts planned

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351 patients to be accrued in 2:1 randomization

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Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center, and Principal Investigator of the VERSATILE-003 clinical trial, will present.

Initial results of MC200710 investigating therapeutic vaccine (PDS0101) alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV associated oropharyngeal carcinoma, a Phase 2 window of opportunity trial" (Abstract #6061) – Poster Presentation. June 2, 2025, 9:00 a.m.-12:00 p.m. CDT

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In the prospective Phase 2 trial, newly diagnosed patients were administered two (2) cycles of Versamune HPV alone or in combination with pembrolizumab before surgical resection or chemoradiotherapy (CRT).

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Results:

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Clinical activity was seen with only 2 cycles of Versamune HPV alone and with 2 cycles of Versamune HPV with pembrolizumab

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70% of patients who received Versamune HPV alone had stable disease

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100% of patients who received Versamune HPV with pembrolizumab had stable disease or partial response

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The combination of Versamune HPV and pembrolizumab met the trial’s primary endpoint of 50% reduction in circulating tumor DNA (ctDNA) response.

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David M. Routman, M.D., Assistant Professor of Radiation Oncology, Department of Radiation Oncology, Mayo Clinic, will present the poster.

Conference Call Details

Date: May 23, 2025
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On May 22, 2025 Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox platform-based photoimmunotherapy, reported that it will present a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 30 – June 3, 2025, in Chicago, Illinois (Press release, Rakuten Medical, MAY 22, 2025, View Source [SID1234653328]).

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The poster will feature Rakuten Medical’s ongoing global Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab (anti-PD-1) as a first-line therapy for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). The poster will also highlight interim findings from the completed Phase 1b/2 study (ASP-1929-181 / ClinicalTrials.gov Identifier: NCT04305795) which evaluated ASP-1929 photoimmunotherapy in combination with anti-PD-1 in recurrent or metastatic HNSCC.

"We are honored that our Trial in Progress poster has been accepted for presentation at ASCO (Free ASCO Whitepaper) 2025," said Anastasios Maniakas, MD, PhD, Assistant Professor in the Department of Head and Neck Surgery and an investigator of the ASP-1929-381 study at The University of Texas MD Anderson Cancer Center. "This Phase 3 study represents a significant step forward in evaluating the potential synergistic efficacy of ASP-1929 photoimmunotherapy and pembrolizumab as a first-line treatment for patients with recurrent HNSCC. We look forward to sharing our progress with the global oncology community and advancing innovative approaches for the treatment of patients facing this challenging disease."

Rakuten Medical is also pleased to announce that it has recently initiated patient enrollment in Taiwan as part of its global expansion of the Phase 3 ASP-1929-381 study. Currently, over 10 clinical sites across the United States and Taiwan are actively enrolling patients. Additional sites are expected to be activated in both regions, with patient enrollment in Japan anticipated to begin shortly.

"We are pleased to be part of this global Phase 3 study and to contribute to the development of an innovative treatment approach like photoimmunotherapy," said Kai-Ping Chang, MD, PhD, Professor of the Department of Otolaryngology – Head & Neck Surgery and Principal Investigator of the ASP-1929-381 study at Chang Gung Memorial Hospital in Taiwan. "Head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan1. Local recurrence or metastasis is one of the leading causes of death in these patients2, and nearly half of those with recurrent or metastatic disease survive for less than one year3. By participating in this trial, we hope to help advance new therapeutic options that may prolong overall survival of patients with recurrent HNSCC, both in Taiwan and around the world."

ASCO attendees are invited to visit Rakuten Medical at booth #33110 to learn more about the ASP-1929-381 study and the company’s broader Alluminox platform.

Rakuten Medical’s Trial in Progress Poster Overview

Abstract Title: A phase 3 randomized study of ASP-1929 photoimmunotherapy in combination with pembrolizumab versus standard of care in locoregional recurrent head and neck squamous cell carcinoma (HNSCC)
Abstract Number: TPS6122
Abstract Link: View Source
Session: Poster Session – Head and Neck Cancer
Date: Monday, June 2, 2025
Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: Anastasios Maniakas, The University of Texas MD Anderson Cancer Center, TX, the U.S.
Location: Exhibit Hall A, Poster Board # 523b
Rakuten Medical Exhibit Booth

Location: Exhibit Hall A, Booth #33110
Exhibit Date: Saturday – Monday, May 31 – June 2, 2025
About ASP-1929-381 Study
The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. 412 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician’s choice.
The primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR).

On May 22, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported new data demonstrating the significant clinical impact of the Breast Cancer Index (BCI) test, which will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2025 (Press release, Hologic, MAY 22, 2025, View Source [SID1234653344]).

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"These data highlight the critical role the Breast Cancer Index test plays in guiding extended endocrine therapy decisions for women with early-stage, hormone receptor-positive (HR+) breast cancer," said Jennifer Schneiders, PhD, President of Diagnostic Solutions at Hologic. "As the only genomic test recognized by clinical practice guidelines to inform such decisions, the BCI test is a powerful tool in personalized care. These findings reinforce our commitment to delivering clinically validated diagnostics that support treatment decisions based on each patient’s unique tumor biology."

During the meeting, Hologic will share the latest analysis of the prospective, multi-center BCI Registry Study, which evaluated how the BCI test influences clinical decision-making for extended endocrine therapy in patients with early-stage, HR+ breast cancer. Building on initial published data, this assessment reflects an even more comprehensive analysis of more than 2,800 patients. The latest data showed BCI testing led to a change in treatment recommendations for about 4 in 10 cases. Importantly, physician confidence in treatment recommendations also increased and patients reported feeling more comfortable with their treatment decisions, citing fewer concerns about cost, drug safety and preference related to extended endocrine therapy benefit.1

"Incorporating the Breast Cancer Index test into the conversation about extended endocrine therapy helps doctors and patients make decisions with more confidence and comfort," said Tara Sanft, MD, Associate Professor of Medicine at Yale School of Medicine and primary investigator of the new study. "As oncologists, we often look at clinical and pathologic factors to assess our patients’ risk of recurrence, but these factors are not enough to tell us whether longer treatment is likely to reduce that risk and may lead to misguided recommendations. Genomic testing with the BCI test allows us to determine which women are likely to derive benefit from extended endocrine therapy to make more informed, shared decisions with our patients."

The data presentations at ASCO (Free ASCO Whitepaper) 2025 focusing on the BCI test include:

Prospective Decision Impact Study of the Breast Cancer Index: Results from the BCI
Registry Study (Abstract #531/Poster Board #124)
Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
The expanded assessment of the BCI Registry Study found that incorporating the BCI test into clinical practice significantly influenced extended endocrine therapy decisions for early-stage, HR+ breast cancer patients.1
Assessment of Ovarian Function Suppression (OFS)-Containing Adjuvant
Endocrine Therapy in Premenopausal Women by Breast Cancer Index (Abstract #557/Poster Board #150)
Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
These translational data from the landmark Tamoxifen and Exemestane Trial (TEXT) trial further validate the ability of the BCI test to assess risk of overall and late distant recurrence in premenopausal women with early-stage, HR+ breast cancer.2*
About the Breast Cancer Index Test

The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index test as a biomarker to help inform extended endocrine treatment decisions.3,4 It is the only test recognized by guidelines to predict the likelihood of benefit from extended endocrine therapy.3,4

The Breast Cancer Index test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a laboratory-developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory. For more information, visit www.breastcancerindex.com.

On May 22, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that results from the Company’s positive phase 3 clinical trial of aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL from May 30 to June 3, 2025 (Press release, Candel Therapeutics, MAY 22, 2025, View Source [SID1234653298]).

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The objective of this study was to assess whether adding CAN-2409 in combination with the prodrug valacyclovir to standard of care radiation therapy could improve the proportion of patients achieving disease-free survival (DFS) among those pursuing curative treatment for newly diagnosed localized prostate cancer. The selection of DFS as the primary endpoint was a key element of the Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA).

The Company’s phase 3 clinical trial met its primary endpoint and secondary endpoints and demonstrated statistically significant improvement in DFS (p=0.0155) with a 30% reduction (HR 0.7) in the risk for prostate cancer recurrence or death due to any cause in patients who received CAN-2409 (n=496) compared to placebo (n=249). These results were initially announced in December 2024.

This is the first multicenter, randomized phase 3 trial in over 20 years to meet both primary and secondary endpoints in localized prostate cancer, potentially redefining treatment for intermediate-to-high-risk patients with prostate cancer who seek curative therapy to avoid cancer-related anxiety, salvage treatments associated with toxicity, and disease progression.

Glen Gejerman, M.D., MBA, Co-Director of Urologic Oncology at Hackensack Meridian Health, and one of the principal investigators of the study, stated, "The improvement in disease-free survival shown in this trial is not only statistically significant, but also clinically meaningful. The clinical findings were reinforced by tissue analysis: CAN-2409 led to a significantly higher rate of pathological clinical response in two-year biopsy samples compared to placebo, indicating that the cancer may have been eliminated at the microscopic level. Effective local control of prostate cancer is essential in patients who seek treatment with curative intent, as patients with positive prostate biopsies, two or more years after radical treatment, face a well-established higher risk of disease spreading within the pelvic region, developing distant metastases, and ultimately dying from prostate cancer during long-term follow-up."

"We are honored that our pivotal phase 3 CAN-2409 data will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, reinforcing the strength of our previously announced results," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "There remains a significant unmet need among patients with intermediate-to-high-risk localized prostate cancer treated with curative intent, as approximately 30% experience disease recurrence following radical prostatectomy or radiotherapy. In the phase 3 study, the addition of CAN-2409 plus valacyclovir to standard of care radiotherapy significantly reduced the risk of tumor recurrence, with a generally favorable tolerability profile. The observed improvements in disease-free survival and pathological complete response rates underscore the promise of this innovative immunotherapy. As we continue advancing our regulatory preparations in anticipation of submitting a Biologics License Application for CAN-2409 in the fourth quarter of 2026, our focus remains on bringing this potentially transformative treatment to patients in need of better options."

Key Findings to be Presented at ASCO (Free ASCO Whitepaper) 2025 Include:

Primary Endpoint:

Statistically significant improvement in DFS for CAN-2409 plus radiation therapy (n=496) vs. radiation therapy alone (n=249) (p=0.0155; HR 0.7) in the intent to treat population.

Secondary & Exploratory Endpoints:

DFS improvement was observed both in patients receiving short term androgen deprivation therapy (ADT) and in patients not receiving ADT.

In an analysis that focused on prostate-specific outcomes (e.g., censored mortality due to other causes), CAN-2409 showed a highly significant effect (p=0.0046; HR 0.62) on prostate cancer-free survival.

Significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir (<0.2 ng/ml) was observed in the treatment arm compared to the placebo control arm (67.1% vs. 58.6%, respectively; p=0.0164).

CAN-2409 induced 80.4% pathological complete responses in the two-year post-treatment biopsies compared to 63.6% observed in the control arm (p=0.0015).

Safety Profile:

CAN-2409 was generally well tolerated, with a low incidence of treatment related, serious adverse events in both arms (1.7% on CAN-2409 + standard of care vs. 2.2% on placebo + standard of care).

The most common CAN-2409-related adverse events were flu-like symptoms, fever, and chills, which were generally mild-to-moderate in severity and self-limited.

Presentation details:

CAN-2409 – Localized Prostate Cancer

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Abstract Title: Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer
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Presenter: Theodore DeWeese, M.D.*, the Francis Watt Baker, M.D., and Lenox D. Baker Jr., M.D., Dean of the Medical Faculty and CEO, Johns Hopkins Medicine
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Session Title: Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile
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Session Date/Time: Tuesday, June 3, 2025; 9:45 AM – 12:45 PM CT
•
Location: Hall D1, McCormick Place Convention Center, Chicago, IL
* Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. He has never received reimbursements, consulting fees, or any other fees from Candel, and he has no shares of common stock, options to purchase common stock or any other affiliation with Candel.

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies.

Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, for the treatment of stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and for the treatment of localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a SPA agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC.

On May 22, 2025 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a new commercial partnership and co-marketing agreement with ID Solutions, a French provider of high-quality digital PCR (dPCR) assays and customized molecular testing solutions for oncology and other disease areas, to expand the availability of dPCR assays for oncology research applications (Press release, Qiagen, MAY 22, 2025, View Source [SID1234653314]).

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The combination of QIAGEN’s global reach and automation expertise with the assay development and manufacturing capabilities of ID Solutions will strengthen QIAGEN’s position in oncology research.

Under the agreement, ID Solutions will manufacture and supply dPCR assays for non-clinical research use on QIAGEN’s QIAcuity platforms. These assays are optimized to simultaneously detect multiple mutations in cell-free DNA (cfDNA) from plasma and genomic DNA (gDNA) from formalin-fixed, paraffin-embedded (FFPE) tissue. QIAGEN will commercialize these kits starting in Europe as the first region, with the potential for future expansion into other regions.

This agreement supports QIAGEN’s strategic focus on accelerating the adoption of the QIAcuity dPCR platform in oncology research. The new assays expand QIAGEN’s portfolio, complementing the existing PanCancer Kits for detecting multiple hallmark mutations in DNA from diverse sample types and over 200 LNA (locked nucleic acid) Mutation Assays available via its GeneGlobe platform. This unique platform integrates pre-designed assays with a database of more than 10,000 biological entities, including genes, miRNAs, pathogens and pathways.

"Through our collaboration with ID Solutions, we are reinforcing our commitment at QIAGEN to providing comprehensive dPCR solutions on QIAcuity that address critical needs in oncology research," said Simona Grandits, Vice President, Head of Commercial Operations for the Europe, Middle East and Africa (EMEA) Region at QIAGEN. "This agreement expands our assay portfolio, strengthens our position in oncology research, and supports faster, more reproducible results on the QIAcuity platform for our customers."

The partnership aligns with ID Solutions mission to develop its assays for research use only on fully integrated platforms. "Partnering with QIAGEN enables us to extend the reach of our high-quality dPCR assays to more laboratories," said Lise Grewis, CEO, ID Solutions. "Together, we’re enabling faster adoption of dPCR in oncology research with robust, reliable results."

For customers, this partnership translates into streamlined access to ready-to-use assays optimized for QIAcuity in non-clinical oncology research, expanding beyond the current menu, enabling results in less than a day and meeting the growing demand for deeper molecular insights.

To learn more about QIAGEN’s dPCR solutions and the new assays available through this partnership, visit View Source