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Haystack Oncology and Alliance Foundation Trials collaborate to use Haystack MRD™ technology in phase II clinical trial for unresectable stage III NSCLC

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Haystack Oncology (DGX) collaborates with Alliance Foundation Trials, LLC (AFT) to utilize its personalized MRD technology (Haystack MRD™) in AFT-57 clinical trial for unresectable stage III non-small cell lung cancer. The study, supported by Genentech, will evaluate the efficacy and safety of atezolizumab with or without tiragolumab in conjunction with chemoradiotherapy.
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The collaboration between Haystack Oncology and Alliance Foundation Trials (AFT) represents a significant stride in the application of minimal residual disease (MRD) technology within oncology clinical trials. The utilization of Haystack MRD™, which is designed for highly sensitive circulating tumor DNA (ctDNA) analysis, could potentially revolutionize the way therapeutic responses are measured in cancer treatment. By providing detailed molecular insights, this technology can help in the early detection of cancer relapse, thus influencing treatment decisions and potentially improving patient outcomes.

MRD technology is a burgeoning field in cancer research and its integration into a phase II clinical trial for NSCLC is indicative of its growing importance. If the trial demonstrates that MRD technology can effectively gauge the efficacy of novel immunotherapy regimens, this could lead to broader adoption in clinical practice. Such advancements could alter the competitive landscape of the oncology diagnostics market, potentially benefiting Quest Diagnostics' position in the industry.

The integration of personalized MRD technology in evaluating the efficacy of atezolizumab and tiragolumab in NSCLC is a notable development. Atezolizumab, an anti-PD-L1 therapy and tiragolumab, an anti-TIGIT therapy, are part of a class of immunotherapies that have shown promise in treating various cancers by enhancing the immune system's ability to fight cancer cells. The combination of these drugs with chemoradiotherapy could potentially offer a more effective treatment protocol for patients with unresectable stage III NSCLC.

From a medical perspective, the trial's outcomes could have significant implications for patient care. Should the MRD technology prove to be a reliable predictor of treatment success, it could lead to more personalized and timely adjustments in therapy, ultimately improving survival rates and quality of life for patients with this challenging condition.

The strategic partnership between Haystack Oncology and AFT, supported by Genentech, is likely to be viewed positively by investors, given the potential for commercialization of new diagnostic tools and treatments for NSCLC. The success of the AFT-57 trial could lead to increased demand for Haystack MRD™, providing Quest Diagnostics with a new revenue stream and possibly leading to an uptick in the company's stock performance.

Furthermore, the pharmaceutical industry's increasing focus on precision medicine and personalized treatment approaches signals a shift towards therapies with higher efficacy and lower side effects, which could drive long-term growth for companies like Quest Diagnostics. However, investors should consider the inherent risks associated with clinical trials, including the possibility of negative results that could impact the perceived value of the MRD technology and the associated treatments.

BALTIMORE, Jan. 8, 2024 /PRNewswire/ -- Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, has entered into a collaboration with Alliance Foundation Trials, LLC (AFT) for research use of Haystack Oncology's personalized MRD technology (Haystack MRD™) to analyze therapeutic response and provide molecular insights for AFT's interventional, randomized phase II clinical trial (AFT-57) in patients with unresectable stage III non-small cell lung cancer (NSCLC). The AFT-57 clinical study is supported by Genentech, a member of the Roche Group, and will explore the efficacy and safety of an anti-PD-L1 atezolizumab (Tecentriq®) with or without tiragolumab (anti-TIGIT) in conjunction with chemoradiotherapy.

"This research collaboration with AFT is a great opportunity to further explore the benefits of using highly sensitive and specific ctDNA analysis as a means to evaluate the efficacy of novel therapeutic approaches," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Haystack MRD was purpose-built to detect ctDNA with unparalleled sensitivity, making it well-positioned to support the innovation of new treatment regimens."

"AFT is excited to work with Haystack Oncology to investigate promising new immunotherapy-based treatments in nationwide randomized cancer clinical trials," said David Kozono, MD, PhD, AFT Executive Officer and Alliance Immuno-Oncology Committee Co-Chair. "The new MRD technology, in conjunction with these novel therapies, offers a unique opportunity to significantly impact the lives of patients with inoperable locally advanced non-small cell lung cancer."

About Haystack Oncology
Haystack Oncology represents the culmination of over 20 years of technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD™, a next generation tumor informed approach for the measurement of minimal residual disease. Haystack MRD uses an error-corrected ctDNA technology to detect down to one ctDNA molecule in a million. Haystack Oncology works with biopharmaceutical companies to advance important therapeutics to global markets, from early phase clinical development to companion diagnostics. By detecting patients with measurable disease for enrollment, and helping to identify early treatment response and disease clearance as endpoints for treatment efficacy, Haystack Oncology can accelerate and improve the efficiency of clinical development programs. Haystack Oncology testing is CLIA certified in the US and is available for biopharmaceutical clinical development in laboratories located in Baltimore, Maryland, Hamburg, Germany and Helsinki, Finland. Learn more at haystackoncology.com.

About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com.

About Alliance Foundation Trials, LLC
Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network, research collaborators, and non-NCI funding sources. AFT seeks to fulfill the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer. To learn more about AFT studies, visit AllianceFoundationTrials.org.

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SOURCE Quest Diagnostics

FAQ

What is the collaboration between Haystack Oncology and AFT about?

Haystack Oncology (DGX) has entered into a collaboration with Alliance Foundation Trials, LLC (AFT) to utilize its personalized MRD technology (Haystack MRD™) in the AFT-57 clinical trial for unresectable stage III non-small cell lung cancer.

What is the purpose of the AFT-57 clinical trial?

The AFT-57 clinical trial, supported by Genentech, aims to evaluate the efficacy and safety of atezolizumab with or without tiragolumab in conjunction with chemoradiotherapy for patients with unresectable stage III non-small cell lung cancer.

Who is involved in the AFT-57 clinical trial collaboration?

Haystack Oncology (DGX) and Alliance Foundation Trials, LLC (AFT) are collaborating for the research use of Haystack MRD™ technology in the AFT-57 clinical trial, supported by Genentech.

What is the significance of the new MRD technology in the clinical trial?

The new MRD technology offers a unique opportunity to significantly impact the lives of patients with inoperable locally advanced non-small cell lung cancer by providing molecular insights and analyzing therapeutic response.

Who are the key personnel involved in the collaboration?

Dan Edelstein, Vice President and General Manager of Haystack Oncology, and David Kozono, MD, PhD, AFT Executive Officer and Alliance Immuno-Oncology Committee Co-Chair, are key personnel involved in the collaboration.

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