Stage III Colon Cancer

Labcorp® Plasma Detect™ now available for clinical use to assess risk of recurrence in stage III colon cancer patientsFDA-authorized liquid biopsy assay PGDx elio® plasma focus™ Dx now available to support treatment selection BURLINGTON, N.C., April 23, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the expansion of its precision oncology portfolio with two solutions: Labcorp Plasma Detect for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients, and the availability of PGDx elio plasma focus Dx, the first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments. Continue Reading Photo courtesy of Labcorp "Labcorp is dedicated to providing oncologists with a comprehensive portfolio of innovative solutions that enable precise, timely and personalized treatment decisions," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "With the expansion of our portfolio to include Labcorp Plasma Detect for clinical use and the availability of PGDx elio plasma focus Dx to support patient treatment selection, we're advancing care across the oncology spectrum, solidifying our commitment to transforming cancer diagnostics and improving patient outcomes." Labcorp Plasma Detect: Advanced Risk Assessment for Colon Cancer Patients Stage III colon cancer has a nearly 30% recurrence rate within five years. Labcorp Plasma Detect is a blood-based test using whole-genome sequencing (WGS) to detect circulating tumor DNA (ctDNA), indicating the presence of molecular residual disease (MRD).i Patients who are MRD-positive after cancer treatment have a higher risk of recurrence and a poorer prognosis. Labcorp's test detects cancer recurrence risk that conventional methods might miss, helping to identify patients who could benefit from additional treatment or therapy. Key Features of Labcorp Plasma Detect: The test is Labcorp's first tumor-informed MRD solution for clinical use to support recurrence risk stratification. Labcorp Plasma Detect launched in 2024 for biopharma use to support exploratory and investigational studies. The test combines a WGS approach, without the need for a bespoke panel, with proprietary bioinformatics to deliver ctDNA detection down to a limit of detection (LOD95) of 0.005%. Results are available approximately 14 days after Labcorp receives the initial sample, and seven days for subsequent monitoring time points for each patient. Labcorp Plasma Detect is currently being evaluated in more than 10 clinical studies in the U.S. and internationally to assess MRD across various cancer types. Labcorp Plasma Detect will be offered initially through an Early Experience Program, with the intent to expand availability more broadly. PGDx elio plasma focus Dx Now Available for Use to Aid in Treatment Selection PGDx elio plasma focus Dx is the first and only kitted pan-solid tumor liquid biopsy test to receive De Novo authorization from the FDA. This assay provides oncologists with a validated tool to assess various solid tumors for targeted treatment selection – all from a simple blood draw. Key Features of PGDx elio plasma focus Dx: The kitted model allows clinical laboratories and hospitals to retain control over patient specimens and data for research, care management and other clinical purposes. As an FDA-authorized assay, PGDx elio plasma focus Dx requires only on-site verification – as opposed to a full validation – enabling more rapid implementation. Once implemented, this rapid, scalable liquid biopsy genomic test provides actionable findings within a 4-to-5-day turnaround time, from isolated nucleic acid to variant report. As part of the PGDx elio platform, the kitted model is compatible with FDA-cleared PGDx elio™ tissue complete, enabling seamless, in-house tissue-to-liquid reflexing and efficient comprehensive genomic profiling workflows. Labcorp at the American Association for Cancer Research (AACR) 2025 Annual Meeting Labcorp will present key studies at the AACR 2025 Annual Meeting, including the clinical use of Labcorp Plasma Detect and performance of PGDx elio plasma focus Dx. To learn more, or to connect with Labcorp at AACR in Chicago, visit For more information about Labcorp's Oncology solutions, contact us at About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at . i The term MRD is often used interchangeably between molecular residual disease and minimal residual disease. Labcorp Plasma Detect detects molecular residual disease, which is defined as the subclinical presence of a cancer-associated biomarker indicating a high risk of recurrence, which cannot be detected by standard imaging techniques. MRD terminology is in accordance with the BLOODPAC Consortium. SOURCE Labcorp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

FRIDAY, Jan. 31, 2025 -- Adjuvant treatment with 160 mg aspirin daily for three years cuts recurrence rates in patients with colorectal cancer with somatic alterations in the phosphoinositide 3-kinase (PI3K) signaling pathway, according to a study presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, held Jan. 23 to 25 in San Francisco. Anna Martling, M.D., Ph.D., from the Karolinska Institutet in Stockholm, and colleagues randomly assigned 626 patients with stage I to III rectal cancer or stage II to III colon cancer with somatic alterations in the PI3K signaling pathways to either 160 mg of aspirin daily or placebo, within three months after surgery and continued for three years, as part of the ALASCCA trial. The researchers found that after three years of follow-up, time to recurrence was lower for participants assigned to aspirin versus placebo ( PIK3CA mutations in exon 9 and/or 20: hazard ratio, 0.49; 95 percent confidence interval [CI], 0.24 to 0.98; P = 0.044; PIK3CA mutations outside exon 9/20, PIK3R1 mutations, or PTEN mutations: hazard ratio, 0.42; 95 percent CI, 0.21 to 0.83; P = 0.013). A similar trend was seen for disease-free survival (hazard ratios, 0.61 [95 percent CI, 0.34 to 1.08; P = 0.091] and 0.51 [95 percent CI, 0.29 to 0.88; P = 0.017], respectively). Aspirin-related severe adverse events occurred in three patients (one gastrointestinal bleeding, one hematoma, and one allergic reaction). "We have studied and demonstrated the value of a widely used, well-established, and cost-effective drug with a low-risk profile for patients with colorectal cancer," Martling said in a statement. "In addition, this research highlights the importance of precision medicine and the use of advanced diagnostics. These tools can enable tailored treatments and the repurposing of existing drugs for new applications." Several authors disclosed ties to the pharmaceutical industry. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

AUSTIN, Texas,--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced new data from the randomized, Phase III CALGB (Alliance) / SWOG 80702 study. The study will be presented today, Jan. 25, 2025 as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA. This first-of-its-kind study evaluated whether Signatera-positive patients benefit from an escalation in adjuvant treatment. In the trial, Signatera was used to evaluate the benefit of adding celecoxib, a non-steroidal anti-inflammatory drug (NSAID), to standard of care (SOC) adjuvant chemotherapy with FOLFOX in the management of stage III colorectal cancer (CRC). The pre-specified analysis included approximately 1,000 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX (+/-) celecoxib. Key findings included: Signatera-positivity after surgery was predictive of a disease-free survival (DFS) and overall survival (OS) benefit with the addition of celecoxib to adjuvant FOLFOX. The addition of celecoxib to SOC chemotherapy significantly improved DFS compared to placebo (HR 0.55, 95% CI 0.39-0.80; p=0.001) among Signatera-positive patients with a three-year DFS of 44.1% versus 26.6%. Similar results were seen for OS (HR 0.58, 95% CI 0.38-0.90; p=0.013). No survival benefit was seen by adding celecoxib to chemotherapy in Signatera-negative patients. Signatera status after surgery and prior to starting adjuvant therapy was highly predictive of recurrence. Signatera-positivity was significantly associated with worse DFS (HR 7.14, 95% CI: 5.54-9.21; p<0.0001) and OS (HR 6.72, 95% CI: 4.91-9.18; p<0.0001). “ The results from the CALGB (Alliance) / SWOG 80702 study mark an unprecedented moment in personalized medicine for patients with colorectal cancer,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. “ We demonstrated Signatera’s ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable, and well-tolerated therapy. These data also offer compelling evidence to address an unmet need in adjuvant colorectal cancer treatment, where there has not been a new drug approval in over 20 years.” The results of the randomized, double-blind ALTAIR clinical trial will also be presented in a poster today. ALTAIR examined treatment escalation with Trifluridine/Tipiracil (FTD/TPI) in patients with stage I-IV colorectal cancer. In the trial, 243 Signatera-positive patients were randomized to FTD/TPI or placebo over a six-month treatment period. The results showed a trend toward benefit in the FTD/TPI group (median DFS of 9.3 months vs. 5.6 months in the placebo group), although it did not reach statistical significance (HR, 0.79; P = 0.107). There was a significant benefit for resected oligometastatic stage IV patients treated with FTD/TPI, showing a median DFS of 9.76 months as compared to 3.96 months in the placebo group (HR, 0.53; P = 0.012). This presents an opportunity for clinical benefit in stage IV patients who test positive for MRD. About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .