ctDNA-Based MRD Test to Detect As Few As One Mutant Molecule in a Million DNA Molecules

Circulating tumor DNA (ctDNA) detection is a non-invasive method to assess tumor burden with a blood sample. Recent data also correlate ctDNA levels in post-surgical cancer patients with recurrence-free survival (RFS) and risk of recurrence. Now, a best-in-class personalized cancer diagnostic test that is currently under development and planned for 2023 commercialization can detect as few as one mutant molecule in a million DNA molecules, positioning it as the most sensitive ctDNA-based MRD test for use in solid tumors.

Haystack Oncology (Baltimore, MD, USA) plans to expand accessibility to its groundbreaking ctDNA-based MRD testing platform, Haystack Duo, a low-error rate, next-generation chemistry that enables ultrasensitive and personalized MRD testing. Liquid biopsy approach delivers unparalleled sensitivity and specificity for detection of low-frequency mutant molecules to see what others can't. Haystack is pioneering research in liquid biopsy technologies to detect with high sensitivity and specificity the presence of any traces of MRD – small numbers of residual tumor DNA molecules left in the body following initial treatment. These ctDNA molecules are a marker of the presence of cancer and indicate that the disease will recur. Haystack's testing is designed to help inform clinical interventions by creating personalized diagnostic panels to customize optimal treatment plans for each patient, independent of a tumor's origin.

Haystack's tumor-informed liquid-biopsy-based test begins with tissue-based whole-exome sequencing to identify patient-specific tumor mutations. A personalized MRD test is then developed to detect ctDNA from residual, recurrent or resistant disease. A version of Haystack's technology was utilized in the landmark DYNAMIC clinical study of stage II colon cancer patients post-surgery. Results from the study reported earlier this year demonstrated that applying Haystack's ctDNA-guided approach to the treatment of stage II colon cancer significantly reduced the use of adjuvant chemotherapy without compromising recurrence risk or survival at two years.

"Detecting MRD has long been akin to looking for a needle in a haystack – we're searching for a small number of tumor-derived DNA molecules in a sea of normal molecules in a blood sample. If residual disease is detected, the patient journey can be transformed to greatly improve the likelihood of clinical benefit, and ultimately, save lives," said Dan Edelstein, President and CEO of Haystack. "Haystack's mission is to deliver earlier, more precise detection of residual and recurrent tumors to personalize therapy and dramatically improve outcomes for patients with cancer."

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