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Quest Diagnostics Now the Largest Clinical Reference Lab to Extend Oncology Test Access Through OncoEMR MPI

On July 8, 2026 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported it is integrating its Haystack MRD ctDNA test and Comprehensive Genomic Profiling services for solid tumor cancers within OncoEMR, an electronic health record (EHR) from Flatiron Health, via a pilot program with American Oncology Network (AON) and other community oncology providers. Flatiron Health is a leading healthtech company dedicated to expanding the possibilities of point-of-care solutions in oncology.

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Quest is the largest clinical reference lab to integrate oncology tests in OncoEMR using the opt-in OncoEMR Molecular Profiling Integration (MPI) ordering feature, which is designed to support the specialized test ordering requirements of comprehensive molecular tests. Once completed, the integration will enable 4,700 clinicians across the Flatiron network of 1,600 community-based cancer care locations in the United States to quickly access the Quest services.

"At Flatiron, we’re focused on helping oncology teams get the answers they need to deliver the best possible care," said Quincy Weatherspoon, Chief Network Officer, US Point of Care, Flatiron Health. "By integrating Quest’s advanced oncology services directly into existing workflows, we’re making it easier for physicians to access critical testing insights without adding complexity to their day. This collaboration helps reduce administrative burden so clinicians can spend less time navigating processes and more time focused on caring for patients with cancer."

Molecular oncology testing often involves dozens or even hundreds of individual genetic biomarkers, which can complicate ordering workflows and producing long, complex results reports. The use of OncoEMR MPI will enable providers to set up accounts for Quest services faster, order tests with fewer steps, and receive easy-to-understand reports within their daily EHR workflows.

Select providers can now order and receive results from Quest using the OncoEMR MPI capability as part of a pilot program. Among the pilot customers is American Oncology Network (AON), a leader in community oncology with more than 350 providers practicing across 21 states. Nearly 200 AON sites now have access to OncoEMR MPI and can use it to order the Quest tests. Quest plans to launch the full OncoEMR MPI integration to providers nationwide in the second half of the year.

"At AON, our aim is to provide comprehensive support, ancillary services and practice management benefits to help community physicians to make cancer care better. Empowering them to use OncoEMR MPI via Quest Diagnostics is an important step in that mission," said Dr. Brian Mulherin, Medical Director at AON. "Under this arrangement, our rapidly growing network of physicians can quickly and easily order Quest’s innovative cancer tests, such as Haystack MRD, to help guide patient care."

Providers in the pilot now have access to some of Quest’s most innovative cancer tests, including Haystack MRD, a highly accurate circulating-tumor DNA (ctDNA) minimal residual disease (MRD) test for solid tumor cancers. In addition, the company’s Comprehensive Genomic Profiling portfolio includes several panels that use advanced sequencing to identify up to 530 genes associated with therapy response, providing physicians with necessary insights to determine appropriate treatment for their patients.

"At Quest Diagnostics, we strive to provide comprehensive cancer services that empower providers to work with patients to make optimal care decisions," said Asia Chang, Vice President and General Manager, Oncology at Quest Diagnostics. "We know that positive outcomes in oncology start with excellent diagnostics, but they don’t stop there. We’re looking forward to providing oncologists at AON and other organizations a single-source ordering and results solution via OncoEMR MPI, as well as the world-class expertise they’ve come to expect from Quest."

Quest’s integration of OncoEMR MPI reflects the company’s strategy to make testing simpler and smarter, including through the use of specialized IT and EHR technologies. Last summer, the company began to offer its Haystack MRD test through the Epic Aura platform and now provides a range of specialized tests, from prenatal screening to Alzheimer’s disease, through the platform.

(Press release, Quest Diagnostics, JUL 8, 2026, View Source [SID1234669106])

STEMCELL Technologies and CCRM Partner to Expand Access to Matched GMP and RUO iPSC Lines for Cell Therapy Development

On July 8, 2026 STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) reported a partnership to expand access to high-quality human induced pluripotent stem cell (iPSC) starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic. Under the agreement, STEMCELL will manufacture and distribute research-use-only (RUO) iPSC lines derived directly from LineaBio’s Good Manufacturing Practices (GMP) iPSC lines, and will offer the matched GMP lines to developers worldwide.

For developers of iPSC-derived cell therapies, the starting cell line is a foundational choice that shapes the entire path to the clinic. A 2026 review in Stem Cell Reports identified 126 human iPSC lines available for clinical applications, but few offer the full set of attributes that reduce development risk: donor consent for commercial and therapeutic use, cleanroom-based GMP manufacturing, comprehensive genomic characterization, and clear freedom to operate. A shortfall in any of these may not surface until late in development, when a change of starting material can trigger a new regulatory filing, adding significant time and cost.

"As a company of Scientists Helping Scientists, STEMCELL is committed to providing cell therapy developers with iPSC starting materials they can rely on as they move from research toward the clinic," said Dr. Allen Eaves, President and CEO, STEMCELL. "By offering LineaBio’s GMP iPSC lines alongside matched RUO lines manufactured from the same material, we are giving scientists a dependable foundation for their work and helping to accelerate the development of new cell therapies."

"LineaBio was founded to give cell therapy developers off-the-shelf GMP iPSC lines backed by the documentation, characterization, and regulatory support they need," said Dr. Michael May, President and CEO, CCRM. "Working with STEMCELL and its reach into research laboratories worldwide, we can expand access to these lines across the research community and help accelerate the next generation of cell therapies for patients. We are proud to advance this work with a fellow Canadian company, expanding access to these tools for scientists worldwide."

LineaBio’s iPSC lines are manufactured under controlled GMP conditions from donor-eligible source material and characterized extensively, including by whole genome sequencing. The flagship line, Linea 1, is certified by the Human Pluripotent Stem Cell Registry (hPSCreg) and supported by a U.S. FDA drug master file, giving developers a standardized chemistry, manufacturing, and controls (CMC) data package they can reference in their own regulatory submissions to shorten their path to GMP and reduce cell line development costs. STEMCELL generates matched RUO counterparts directly from this GMP material and qualifies them using established comparability and genomic assessment frameworks. Because the RUO and GMP lines share the same donor and origin, developers can begin their research on the RUO line with confidence that it is comparable to the GMP material. The partnership will expand to include future GMP iPSC lines, including a hypoimmune line for allogeneic therapies.

The companies will present comparability and genomic concordance data for Linea 1 during the STEMCELL and CCRM Innovation Showcase at the 2026 International Society for Stem Cell Research (ISSCR) Annual Meeting in Montréal, "Accelerating Cell Therapy Development with GMP-Manufactured Human iPSC Lines and Matched RUO Equivalents," presented by Dr. Andrew Gaffney (STEMCELL) and Dr. Janet Rothberg (CCRM) on Wednesday, July 8, at 12:30 p.m. ET in Room 511a, Palais des congrès de Montréal. To learn more about the iPSC lines, visit www.stemcell.com/gmp-ipscs.

(Press release, CCRM, JUL 8, 2026, View Source [SID1234669105])

BioLineRx and Hemispherian Announce New Preclinical Data Demonstrating Strong
Synergistic Effect between GLIX1 and PARP Inhibitor in a Patient-Derived
Ovarian Cancer Xenograft Model

On July 8, 2026 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported highly encouraging new preclinical data demonstrating strong synergy between GLIX1 and PARP inhibitors in a patient-derived xenograft (PDX) model of ovarian cancer.

Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy, as well as for patients with platinum-resistance.

GLIX1 in combination with PARPi is expected to result in synthetic lethality, a mechanism in which GLIX1-induced single-stranded DNA breaks overcome PARP inhibitors’ requirement for HR-deficiency, enabling synergistic activity in HR-proficient cancers. This effect was first observed in vitro, where GLIX1 showed reproducible synergy across different PARP inhibitors and multiple HR-proficient ovarian cancer cell lines, with very high ZIP synergy scores.

"We are very excited to observe, in a patient-derived ovarian cancer model, the synergistic effect as we anticipated based on the mechanistic rationale and as demonstrated by in vitro data" said Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1 has the potential to sensitize patients to PARP inhibitors as well as to potentially address the huge unmet need for patients with platinum-resistance. Based on these highly encouraging data, we plan to include an ovarian cancer arm in the expansion part of our ongoing Phase 1/2a study."

Today’s results represent a compelling in vivo confirmation of GLIX1 and PARPi synergy from an HR-proficient ovarian cancer PDX model.

· The study included six arms: cisplatin, GLIX1 monotherapy and olaparib monotherapy (all at doses expected to be optimal), low-dose GLIX1, a low-dose GLIX1/olaparib combination arm, and a control arm

· Results show substantially better efficacy in the combination arm versus the control arm and versus the monotherapy arms, despite using lower doses in the combination arm

· The low-dose GLIX1/olaparib combination tumor reduction was similar to cisplatin, the current chemotherapy benchmark

BioLineRx and Hemispherian plan to present the data from this study at one or more future medical conferences.

About Ovarian Cancer

Ovarian cancer is the deadliest gynecologic malignancy in the United States, with an estimated approximately 21,000 new cases and 12,450 deaths projected in 2026. Standard first-line treatment consists of cytoreductive surgery and platinum-based chemotherapy, with PARP inhibitors used as maintenance therapy in selected patients, particularly those with BRCA-mutated or homologous recombination (HR)-deficient disease. However, PARP inhibitors are markedly less effective in patients with HR-proficient tumors, which account for approximately 50% of high-grade serous ovarian cancers and are associated with primary platinum resistance and shorter survival. This leaves a substantial and currently underserved patient population in need of new treatment strategies capable of extending the benefits of PARP inhibitors.

About GLIX1

GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death.

About the Phase 1/2a Trial with GLIX1

The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Updates to the Phase 1/2a trial are anticipated during H2 2026, with full results on the dose escalation part expected in 2027.

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

For more information on the Phase 1/2a trial, please visit NCT07464925.

(Press release, BioLineRx, JUL 8, 2026, View Source [SID1234669104])

Cellis Showcases Macrophage-Based Cancer Therapy at the International Conference on Precision Medicine

On July 8, 2026 Cellis reported to have participated in the International Conference on Precision Medicine and the STRIKE Scientific Meeting, held on 2–4 July 2026 in Messina, Italy. The event brought together leading researchers, clinicians, and industry representatives to discuss the latest advances in precision medicine and translational research.

As an invited speaker, our Chief Scientific Officer, Prof. Magdalena Król, presented the lecture titled "Turning Macrophages into Therapeutic Effectors: Immune Reprogramming via the Macrophage Drug Conjugate Platform."

During her presentation, Prof. Król introduced Cellis’ innovative Macrophage Drug Conjugate (MDC) platform, which harnesses macrophages as active therapeutic effectors capable of delivering anti-cancer payloads directly to the tumor microenvironment. The lecture highlighted how immune cell reprogramming can overcome key limitations of conventional drug delivery and open new opportunities for precision oncology.

The conference provided an excellent opportunity to exchange ideas with scientists, clinicians, and innovators working across cancer biology, immunotherapy, nanomedicine, and targeted drug delivery. The discussions reinforced the growing interest in next-generation cell-based therapies and the importance of interdisciplinary collaboration in accelerating their clinical translation.

We thank the organizers for the invitation and the opportunity to present Cellis’ scientific achievements on an international stage. We look forward to building new collaborations and continuing to advance macrophage-based precision therapies for patients with cancer.

(Press release, Cellis, JUL 8, 2026, View Source [SID1234669103])

China’s National Medical Products Administration Accepts Biologics License Application for PADCEV™ (enfortumab vedotin) plus Keytruda® (pembrolizumab) in Muscle-Invasive Bladder Cancer

On July 7, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-containing chemotherapy.

The BLA is supported by results from the Phase 3 EV-303 and EV-304 clinical trials (KEYNOTE-905 and KEYNOTE-B15, respectively). In EV-303, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with surgery alone in MIBC patients ineligible for or who declined cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, the combination reduced the risk of tumor recurrence, progression, or death by 60%.1 In the Overall Survival (OS) analysis, the combination reduced the risk of death by 50%.1

In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard of care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the EFS analysis, enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47%.2 In the OS analysis, enfortumab vedotin plus pembrolizumab reduced the risk of death by 35%.2

In EV-303 and EV-304, the safety profile of enfortumab vedotin plus pembrolizumab was consistent with prior experience with the combination, and no new safety signals were observed.1,2 Across both trials, the most common (≥30%) adverse events (AEs) related to treatment with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab include pruritus (itching), alopecia, diarrhea, and anemia.1,2

According to the latest data from the China National Cancer Center, bladder cancer has an estimated incidence rate of 3.44 per 100,000 people, with more than 480,000 people affected in China.3,4 MIBC represents approximately 30% of bladder cancer cases, and despite curative-intent surgery, approximately half of MIBC patients experience recurrence.5,6

Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2027.

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).7

Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the United States.

Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the European Union, the combination is approved for the treatment of adult patients with la/mUC who are eligible for platinum-containing chemotherapy.

About the EV-303/KEYNOTE-905 Trial
The EV-303 trial (also known as KEYNOTE-905) is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab or neoadjuvant and adjuvant pembrolizumab versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant pembrolizumab (arm A), surgery alone (arm B) or neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab (arm C). Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on imaging, blinded independent central review (BICR), and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.

For more information on the global EV-303 trial, go to clinicaltrials.gov.

About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR or death due to any cause. Key secondary endpoints include OS and pCR rate.

For more information on the global EV-304 trial, go to clinicaltrials.gov.

(Press release, Astellas, JUL 7, 2026, View Source [SID1234670181])