The test helps access the company’s ctDNA tumour fraction biomarker. Credit: Mahmoud Ahmed from Pixabay.

Molecular insights company Foundation Medicine has introduced a new tissue-naive circulating tumour DNA (ctDNA) monitoring assay named FoundationOn Monitor.

The new monitoring assay is designed for use in retrospective studies and provides research insights into treatment response and resistance using a blood sample.

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FoundationOne Monitor, which is currently provided for biopharma customers, allows access to the company’s ctDNA tumour fraction biomarker.

This biomarker includes information to enhance sensitivity, in addition to maintaining high specificity to monitor ctDNA levels.

The test quantifies ctDNA tumour fraction at each time point to provide insights into molecular response to support standard imaging in early-phase clinical research.

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It can also evaluate resistance to therapy across more than 300 genes.

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Foundation Medicine biopharma enterprise partnerships vice-president Jason Adams said: “The addition of FoundationOne Monitor to our monitoring portfolio makes Foundation Medicine a one-stop shop for our biopharma partners’ treatment response monitoring research needs.

“When tissue is not available, FoundationOne Monitor offers comprehensive insights on treatment response to help our biopharma partners study individual variants, identify resistance mechanisms and quantify ctDNA tumour fraction.”

The company’s monitoring portfolio also comprises a precise tissue-informed ctDNA test, called FoundationOne Tracker, designed for treatment-response monitoring to assist in preparing strategies for personalised treatment when tumour tissue is available.

This test was introduced for research application in June 2021, followed by investigational use in January this year and is currently accessed by a limited number of clinical customers via an early access programme.

Foundation Medicine stated that it is planning to expand the availability of the test in the US later this year.