Minimal residual disease (MRD) has become a central concept in modern oncology, reshaping how clinicians evaluate response, relapse risk and treatment precision. As increasingly sensitive technologies reveal traces of cancer that persist after therapy, MRD is emerging as both a biological challenge and a clinical opportunity, especially as new data illuminate its complexity across hematologic and solid tumors. This topic was addressed at the 2026 American Association for Cancer Research (AACR) annual meeting.
In a move that could dramatically shorten some clinical development timelines for drugs targeting multiple myeloma, the U.S. FDA issued a draft guidance on the potential use of minimal residual disease and complete response to support accelerated approvals, following the recommendation of the agency’s Oncologic Drugs Advisory Committee, which voted 12-0 in favor of the change in April 2024.
Natera Inc. completed the acquisition of Foresight Diagnostics Inc. in a deal structured as $275 million up front plus contingent payments of up to $175 million based on achieving certain milestones for revenue and reimbursement coverage. The companies expect to close the transaction in the second quarter of 2026.
With an at least $60 billion total addressable market, the liquid biopsy sector offers abundant opportunity for multiple companies to swim to the top. The six largest companies in the pool have just dipped their toes in the water, with a total penetration of only 10%, a white paper from RBC indicates.
By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials. The FDA will now consider the recommendation, which, if incorporated into future studies, could dramatically shorten some drug developer timelines and offer more options for treating the aggressive bone marrow cancer.
The U.S. FDA thinks using minimal residual disease as an endpoint for accelerated approval in new therapies to treat multiple myeloma (MM) might just be an idea whose time has come. The FDA now wants to know what its Oncologic Drugs Advisory Committee thinks about it, so the agency has convened a meeting of the committee for a deep dive into the subject on April 12.
Allogene Therapeutics Inc.’s decision to preferentially pursue first-line treatment of large B-cell lymphoma (LBCL) with CAR T cemacabtagene ansegedleucel (cema-cel, previously known as ALLO-501A) met mixed reviews on Wall Street.
Mission Bio Inc. released its Tapestri single-cell minimal residual disease (MRD) assay for acute myeloid leukemia (AML) on September 26, with the goal of enabling greater personalization of care for patients with blood cancers. The test can provide insights into the progression of AML and help identify targets for treatment in addition to identifying patients truly experiencing relapse as distinct from having pre-leukemic or precursor clones.
Later this year, Mendus AB plans to move its allogeneic cell-based cancer vaccine, vididencel, into a phase II combination trial with oral azacitidine to evaluate the regimen’s potential as a maintenance therapy in patients with acute myeloid leukemia (AML).
Quest Diagnostics Inc. evidently found what it was looking for, as it agreed to acquire Haystack Oncology Inc. in an all-cash deal valued at up to $450 million with $300 million at closing and $150 million contingent on meeting specific milestones. Haystack focuses on minimal residual disease (MRD) testing, which can detect residual or recurring cancer in its early stages and help guide therapy decisions using blood samples rather than biopsied tissue. The companies expect the transaction to close before the end of June.
