OncoDxRx is aiming to achieve initial operational capability (IOC) for molecular residual disease (MRD) in 2024. Within this capability development process, it is already implementing cell-free mRNA (cfmRNA)-focused MRD in validation and clinical studies, according to the company’s senior officer responsible for delivering the capability.

With its poster presentation accepted and planned at the Association for Diagnostics & Laboratory Medicine (ADLM 2024) in July, OncoDxRx stated that the MRD development path has been laid out by the company’s exclusive technology strategy, that their product OncoMRD is moving towards IOC, and that it is testing and using capability on collaborations. These developments are set against a backdrop of increasingly pressing requirements to deliver MRD testing capability, the company explained. Such requirements are demonstrated in the precision oncology arena.

“The clinical situation is now urgent. The good thing is the way ahead for us is quite clear, the development roadmap is underway, and we are expecting IOC of our one-of-a-kind MRD capability in 2024 with in vitro cfmRNA testing and in silico data computation”.
“This is the right way to multiply effects in therapeutic response monitoring, and to better co-ordinate with drug response prediction (via OncoDxRx’s PGA technology) to ensure success in clinical decision-making and surveillance, recognizing the specific nature of our exclusive assets in cancer management,” said OncoDxRx.

“OncoMRD platform is an end-to-end operational function, from the sample acquisition, processing, testing, analysis to report MRD status,” the company added.

OncoDxRx is focused on three areas: building its overall capacity for novel cfmRNA-enabled systems; mastering capability to use precision diagnostics in every stage of cancer; and improving capability to process and translate data. Capabilities it is developing for OncoMRD also relate to other diagnostics pipelines, including PGA (patient-derived gene expression-informed anticancer drug efficacy) and multi-cancer early detection (MCED).

As regards bilateral activities, in mid-November 2023 OncoDxRx and its Taiwanese partners – started to co-operating on a clinical study – successfully countered what the company referred to as “malicious tumor evolution”. For the study, they operated PGA and OncoMRD assays. This was the first time cfmRNA-powered tests had been conducted in real-world patients in Taiwan, said OncoDxRx.

“We are right now validating with our first OncoMRD operation that is delivering its first clinical benefits,” said the company.

In these contexts, OncoMRD combines patient testing and data analytics to help the clinicians keep pace with tumor dynamic changes. “We are trying to catch up with the urgency of the topic, and trying to develop our knowhow and courses of action in terms of broader, deeper and more effective diagnostics for each patient,” OncoDxRx said. “We want to be deliverable as quickly as we can, and both PGA and OncoMRD assays are made for that.”

“What we are doing in OncoMRD is operationalizing our strategy,” said the company. “This means we test and test and test again new technologies coming from various discoveries and inventions, in order to find a good answer to the question we put on the table – being able to detect cancer from the earliest possible time in order to see what we can intervene with what kind of treatment strategy, and then decide where we would like to monitor.” “We are testing, then devising the technology, and then operationalizing, to have the assets to confirm the concept of our strategy,” OncoDxRx continued.

OncoDxRx’s capability development with OncoMRD is extremely interesting for three reasons:
1. The technology is based on cfmRNA expression instead of cfDNA mutations.
2. It is operating at high sensitivity and specificity. Testing at high specificity is important, because healthy tissues also regularly release low amount of driver mutations into circulation, interfering with cfDNA interpretation.
3. OncoMRD (response monitoring) is developed to combine with PGA (treatment selection) to deliver clinical benefits at the same time.