New MRD Assessment Data Using clonoSEQ® To Be Presented at 2024 ASCO Annual Meeting and EHA2024 Hybrid Congress

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A Testing Renaissance

Headshot of Lance Baldo, MD

Lance Baldo, Chief Medical Officer

The coronavirus pandemic has thrust testing into the spotlight, highlighted by long lines to get tested across the country.  We know that accurate, sensitive, and timely diagnosis is paramount in fighting and containing this virus. The same can be said for many diseases; having the right test goes beyond COVID-19.

Today, in parallel with our efforts to bring forth a novel T-cell-based test for COVID-19 to market soon, another major focus at Adaptive and for those in the oncology community is the ability to test for “minimal residual disease,” or MRD. MRD refers to the small number of cancer cells that can stay in the body during and after treatment. Often, these cells are present at such low levels that they do not cause any physical signs or symptoms. However, they may be a signal that cancer is returning, and their absence can be a signal that the disease is under control.

As one of the strongest predictors of patient outcomes in blood cancer, it is no surprise that more and more oncology and hematology treatment developers are integrating MRD tests into their clinical trials. In fact, we recently entered into a collaboration with GlaxoSmithKline (GSK) to use our clonoSEQ® Assay – the first and only FDA-cleared in vitro diagnostic for MRD monitoring in patients with chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and B-cell acute lymphoblastic leukemia (ALL) – across GSK’s hematology and oncology portfolio. This adds to a number of partnerships already established with AbbVie, Amgen and Genentech which incorporate clonoSEQ into their blood cancer clinical trials.

Not only is the use of MRD testing growing in clinical trials, but it is also becoming more routine in the post-approval patient journey. MRD status can help patients and doctors understand how the body is responding to treatment and make timely course-corrections as needed. Especially today, as novel therapies drive better response, MRD testing is increasingly important to assess the depth and durability of that response, so clinicians are prepared to intervene quickly and patients have the opportunity to make choices and plan.

As MRD testing continues to become more commonplace, we’ve recently launched a study with the primary goal of understanding why and how MRD testing is used in patients with ALL, CLL, MM and Non-Hodgkin’s Lymphoma (NHL) to identify trends and best practices for the broader oncology community. As part of our new WATCH registry, we will be following patients’ MRD data and treatment changes for up to three years to understand how MRD testing with clonoSEQ is used, what decisions physicians are making based on MRD results, and qualitatively, the correlation between MRD and patient outcomes.

Knowing MRD status – with a test that, given sufficient sample input, can detect one cancer cell among a million cells – gives patients and doctors the confidence and empowerment they need to stay in the driver’s seat of their disease. In the coming weeks, there will be a lot of new data shared about innovation in both testing and treatment at the American Society of Hematology meeting. I look forward to sharing some thoughts around those advances soon.

Testing is a backbone of treatment. As oncology treatments continue to advance and become more personalized, and the options continue to widen, so too should our focus on diagnostics to ensure physicians have the best information to make the best decisions for their patients.

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