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Issued on behalf of Oncolytics Biotech Inc.
USANewsGroup.com News Commentary
VANCOUVER, BC, Dec. 31, 2025 /PRNewswire/ -- The precision oncology market surged to $139.4 billion in 2025 and is racing toward $317.5 billion by 2035[1], driven by a fundamental shift in cancer treatment philosophy. Biomarker-guided therapy selection now enables oncology pharmacists and clinicians to match treatments to tumor-specific characteristics rather than relying on blind, one-size-fits-all protocols[2]. This convergence of diagnostic precision and therapeutic targeting defines the investment thesis for Oncolytics Biotech Inc. (NASDAQ: ONCY), Exact Sciences Corp. (NASDAQ: EXAS), Veracyte, Inc. (NASDAQ: VCYT), Hologic, Inc. (NASDAQ: HOLX), and Personalis, Inc. (NASDAQ: PSNL).
The AI in oncology market is projected to explode from $5.1 billion in 2024 to $53.1 billion by 2034, expanding at a remarkable 26.4% CAGR as machine learning transforms diagnostic accuracy[3]. Hospitals have implemented AI-powered patient monitoring systems across healthcare institutions globally[4], supporting real-time clinical decision-making that bridges the gap between early detection and personalized treatment selection.
Oncolytics Biotech Inc. (NASDAQ: ONCY) is a clinical-stage biotech developing pelareorep, an investigational immunotherapy designed to activate the immune system against cancer. The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.
"These results are extremely encouraging," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. "Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study."
The data establishes pelareorep as a precision immunotherapy that delivers meaningful clinical benefit over current treatment standards. Translational analysis revealed that pelareorep increases KRAS-mutant-specific T-cell populations, providing mechanistic proof that it targets this genetic mutation, driving many colorectal and other gastrointestinal cancers.
Equally compelling anal cancer results showed a 30% response rate in second-line squamous cell anal carcinoma, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses demonstrating pelareorep's ability to achieve deep, lasting tumor control.
"Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033," said Jared Kelly, CEO of Oncolytics Biotech. "Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting."
The company plans to sponsor a controlled study in second-line KRAS-mutant colorectal cancer following consultation with key opinion leaders and regulatory authorities. This represents a critical advancement, as Oncolytics will control the data generated and update investors and potential partners at its discretion.
Oncolytics recently established a Gastrointestinal Tumor Scientific Advisory Board to guide registration strategy across pancreatic, colorectal, and anal cancers. The board includes leading oncologists from Rutgers Cancer Institute, Northwestern University, and the principal investigator of the company's pivotal GOBLET study.
Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial currently planned for this disease. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer.
CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, demonstrating proven ability to advance assets through value-creating transactions.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Exact Sciences (NASDAQ: EXAS) announced results from its Oncodetect molecular residual disease test demonstrating strong prognostic performance in early triple-negative breast cancer, one of the most aggressive breast cancer subtypes. The NSABP B-59 substudy, conducted with the NSABP Foundation and German Breast Group, showed post-surgery MRD-positive status was associated with a 30-fold higher risk of distant recurrence compared to MRD-negative patients. Among 147 analyzed patients, 95% who remained ctDNA-negative after surgery stayed free of distant recurrence at 3 years.
"The NSABP Foundation is proud to collaborate on this impactful study," said Dr. Norman Wolmark, chairman, NSABP Foundation. "The strength of these data, particularly the clear separation in distant recurrence curves, highlight the prognostic power of ctDNA and its potential to guide post-surgical management strategies for high-risk breast cancer."
The data, representing one of the largest TNBC MRD datasets analyzed to date, were presented at the San Antonio Breast Cancer Symposium. Exact Sciences plans to submit the data to MolDx in support of Medicare coverage and is also collaborating with the NSABP Foundation on NSABP B-64, a prospective registry trial enrolling 1,800 participants across all breast cancer subtypes.
Veracyte, Inc. (NASDAQ: VCYT) announced the first publications using its Afirma GRID research tool to define the future of thyroid nodule evaluation. The studies, published in Frontiers in Endocrinology and Surgery, used whole-transcriptome-derived data to develop signatures that may provide enhanced prognostic information prior to surgery. In the Cleveland Clinic study of 445 thyroid samples, researchers identified two molecular signatures with potential clinical utility, including an invasion signature predicting a 30% greater likelihood of intermediate or high-risk cancer.
"We introduced Afirma GSC in 2017 to primarily help patients with indeterminate thyroid nodules—those that were not clearly benign or malignant—avoid unnecessary diagnostic surgery," said Dr. Joshua Klopper, Veracyte's medical director for Endocrinology. "Now, Veracyte is working to help clinical researchers better answer the next critical question for thyroid nodule care: for those patients whose nodules are likely cancerous, how much surgery is needed?"
The Afirma GRID database contains sequencing data from over 21,000 expressed genes for more than 200,000 patients with thyroid nodules. While the studies don't yet provide necessary validation for clinical use, they highlight signatures with potential to guide treatment decisions and extent-of-surgery discussions.
Hologic (NASDAQ: HOLX) announced new data demonstrating its Genius AI Detection mammography solution flagged approximately one-third of breast cancer cases initially interpreted as negative in a retrospective analysis of 7,500 digital breast tomosynthesis screening exams at Massachusetts General Hospital. The AI technology accurately identified the location where breast cancer was subsequently diagnosed in these false-negative cases, and flagged almost 90% of the 500 breast cancer cases previously identified by radiologists while correctly localizing their locations. The study analyzed exams performed between 2016 and 2019, with the AI algorithm showing particular effectiveness in identifying invasive ductal carcinomas and lymph node-positive cancers.
"In this study, not only did the AI identify the case as suspicious and warranting additional review, but it also correctly localized the region of interest," said Dr. Manisha Bahl, Associate Director of Quality for Breast Imaging at Mass General Brigham and Associate Professor of Radiology at Harvard Medical School. "While additional research is needed, these findings are promising and highlight AI's tremendous potential to redefine breast cancer detection in the years ahead."
Hologic's deep learning algorithm draws from a large, diverse patient database, providing intelligence for concurrent reading at radiologists' workstations. The company continues advancing its AI-powered screening technology designed to locate lesions likely to represent breast cancer and support decisive interpretation.
Personalis (NASDAQ: PSNL) announced a new publication in Clinical Cancer Research demonstrating its NeXT Personal ultra-sensitive molecular residual disease assay can effectively predict patient outcomes across diverse cancers and immunotherapy modalities. The study analyzed 202 patients with stage IV solid tumors spanning 24 cancer types treated with immune checkpoint inhibitors. The test detected ctDNA in 98% of patients at baseline and showed patients with durable molecular clearance for at least 180 days achieved 100% overall survival.
"Immunotherapy has revolutionized cancer care, but response patterns can be difficult to interpret using imaging alone," said Dr. Rodrigo Toledo, Group Leader of the Biomarkers and Clonal Dynamics Laboratory at VHIO and senior author. "Our findings show that ultrasensitive ctDNA dynamics provide a clear, early molecular view of benefit or non-response, offering a powerful tool to guide patient management across a broad spectrum of solid tumors."
The NeXT Personal test tracks up to 1,800 tumor-specific variants unique to each patient, achieving ultrasensitive detection of circulating tumor DNA. Patients with decreasing ctDNA levels early in treatment had significantly higher overall survival, while those with increasing ctDNA had a zero percent overall response rate.
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