Abbott has announced the launch of a new and improved version of the Oncodetect test, a test dedicated to monitoring minimal residual disease (MRD) by analyzing circulating tumor DNA (ctDNA) in the blood. This technological advancement aims to track the traces of cancer in the body after treatment, providing an early warning signal for disease recurrence before traditional imaging methods can detect it.
A Technological Leap in Genome Sequencing
The new version of the test relies on advanced technology developed at the Broad Institute (affiliated with MIT and Harvard). The technical gap between the current and previous versions lies in the transition from "Whole-exome sequencing" technology to "Whole-genome sequencing", which has brought about a radical transformation in the test's capabilities:
- Expanding the scope of mutations: The test is now able to track up to 5,000 patient-specific cancer mutations, compared to only 200 mutations in the previous version.
- Raising the sensitivity level: The new test was able to detect levels of circulating tumor DNA (ctDNA) of less than one part per million (1 ppm), while sensitivity in the old test ranged between 15 and 50 parts per million.
According to Dr. Rick Baehner, Chief Medical Officer for Precision Oncology at Abbott, the ability to detect a single tumor molecule among more than one million cell-free DNA molecules represents a solution to what was known as the "Achilles' heel" in minimal residual disease tests.
What Changes Practically in Cancer Detection?
The clinical importance of this development lies in its ability to handle cancer types characterized by "low-shedding" or cancers in early stages, such as prostate, lung, kidney, and (HR+) breast cancer.
This ultra-high precision gives doctors greater confidence when declaring a "negative" result to the patient, as it ensures that the probability of cancer recurrence is indeed very low. Clinical data from the (Beta-CORRECT) study showed a 30 percentage point improvement in the sensitivity of detecting colorectal cancer recurrence over two years when using the new test compared to the previous version.
Competitive and Market Context
This launch comes as part of Abbott's strategy to strengthen its oncology diagnostics portfolio following its acquisition of Exact Sciences in a deal valued at $21 billion. This move places Abbott in direct competition with Natera and its (Signatera) test in a massive market; estimates indicate there are more than 3 million potential patients in the United States alone, with current market penetration not exceeding 10%.