Chronix Biomedical welcomes moves to define new regulatory standards in liquid biopsy field

FDA guidance and workshop indicates development of fast emerging liquid biopsy field

Chronix Biomedical, a developer of blood-based molecular diagnostics, welcomes the recent moves to more clearly define US regulatory standards for the use of liquid biopsies in cancer diagnosis, staging and monitoring.

These moves include the publication, earlier this month, of draft FDA guidance on regulation and the public workshop held earlier this week to discuss this and ways of accelerating development in the field.

The joint FDA-AACR workshop was attended by Chronix Biomedical’s Chief Medical/Technology Officer, Professor Dr Ekkehard Schütz, who was particularly encouraged that the panel recognised the potential of liquid biopsies as an early indicator of response to therapy, a key business focus for Chronix Biomedical.

Chronix Biomedical believes it has identified an unmet medical need for a reliable early predictor of response to cancer therapy. Chronix Biomedical and its collaborators have published data at leading scientific conferences this year showing that its test can predict response to therapy after one or two cycles of treatment, approximately 3–8 weeks earlier than is possible using CT scans. This has been found to be the case for three different modalities of cancer treatment: radiotherapy, chemotherapy and immunotherapy.

The ability to obtain an early prediction of response may allow physicians to switch non-responding patients to alternative therapies sooner, which could potentially confer clinical benefits and allow better targeting of expensive therapies.

Chronix Biomedical’s CEO, Dr Howard B. Urnovitz, commented: ‘We are pleased that the FDA and AACR recognise the enormous potential of liquid biopsies to improve cancer care. Clearly, the agency is seeking to balance accelerating development of the field with appropriate regulation. We welcome the opportunity to engage with and comment on the draft guidance. We are actively monitoring the situation and are well positioned to include this opportunity in our business strategy given the evolving regulatory requirements.’

Chronix Biomedical’s technology relies on measuring changes in copy number in tumour cell-free DNA (cfDNA) obtained from blood samples.

Chronix has developed a cancer DNA load test, a proprietary copy number instability (CNI) index that has been shown in pilot studies to be able to predict response to radiotherapy, chemotherapy and immunotherapy.

In the case of immunotherapy, the ability to identify responders early may be particularly important, given the high cost of these new drugs and the observation that they tend to generate profound responses in some patients but are ineffective in others. There is, as yet, no reliable way to identify the likely responders to immunotherapy in advance.