On June 2, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant. Itovebi is a therapy developed by Genentech, a member of the Roche group, which is approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. This decision from the FDA follows the approval of FoundationOneLiquid CDx, Foundation Medicine’s blood-based comprehensive genomic profiling (CGP) test, for the same therapy combination and indication in October 2024.

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Of all breast cancer cases, approximately 70% are HR-positive, HER2-negative.2 Within this patient population, PIK3CA is mutated in approximately 40% of patients.3 An analysis of the agreement of identified PIK3CA mutation status between the FoundationOne CDx and FoundationOne Liquid CDx tests for patients in the INAV0120 trial demonstrated high concordance between the two assays.

"The prevalence of PIK3CA mutations found in HR-positive, HER2-negative breast cancer makes it extremely important to have high quality, FDA-approved tests to match patients to the most effective therapy options in a timely manner," said Todd Druley, M.D., Ph.D., chief medical officer at Foundation Medicine. "While actionable genomic alterations like PIK3CA may be identified by blood-based biopsy, some patients’ tumors may not be shedding adequate levels of tumor DNA into the blood for these alterations to be detected. In these cases, confirmatory tissue testing may help match more breast cancer patients to this therapy."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. With this most recent approval, Foundation Medicine has eight FDA-approved companion diagnostic indications for breast cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company.1,4

"When someone is diagnosed with metastatic breast cancer or experiences a recurrence of their disease, making decisions about treatment can feel extremely overwhelming," said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. "Having two high quality FDA-approved biomarker tests to detect PIK3CA mutations using different sample types opens more doors to help match patients to this targeted treatment regimen in the first line setting."

(Press release, Foundation Medicine, JUN 2, 2026, View Source [SID1234666391])