Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test.

Geoff Oxnard, global medical lead, liquid franchise at Cambridge, Mass.-based Foundation Medicine, told BioWorld that Foundationone Liquid CDx is the broadest FDA-approved liquid biopsy test for all solid tumors. "It is the first FDA-approved liquid biopsy test to analyze more than 300 genes to offer a broader look at potential cancer growth drivers,” he added.

Of note, the test will help identify patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer who may benefit from Rubraca (rucaparib) treatment. This ultimately serve as a great boon for patients.

"From a clinical perspective, I believe physicians should discuss tumor genomic profiling with every metastatic prostate cancer patient to inform the use of targeted and immunotherapies," said Neeraj Agarwal, director of the genitourinary oncology program and professor of medicine at the Huntsman Cancer Institute, Salt Lake City. "This approval addresses the need for blood-based genomic testing options when tissue can be challenging to obtain."

Also with this approval, the test can be used to identify patients for three first-line tyrosine kinase inhibitors – Astrazeneca plc’s Iressa (gefitinib) and Tagrisso (osimertinib) and Tarceva (erlotinib), from Roche’s Genentech – for the treatment of non-small-cell lung cancer. The test will be available Aug. 28, around the globe, except for China and Japan, Oxnard told BioWorld.

He further noted that the list price for the test is $5,800 – the same as Foundationone CDx and the previous Foundationone Liquid test. It also is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria.

“To support our patient-centric mission of advancing cancer care, Foundation Medicine is dedicated to reducing financial barriers that may keep patients from accessing our products. We offer a financial assistance program to help qualifying patients navigate the insurance billing process and reduce the out-of-pocket costs for our tests,” he added.

Word of the approval comes the same month the FDA gave its nod to the first liquid biopsy next-generation sequencing (NGS) CDx test – Guardant Health Inc.'s Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling, in patients with any solid malignant neoplasm.


Earlier this year, Clovis Oncology Inc.'s Rubraca became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer in third-line care. However, the agency subsequently granted a broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Astrazeneca and Merck & Co. Inc. collaborated on Lynparza.

At the same time as that label expansion, Foundation Medicine's Foundationone CDx and Myriad Genetics Inc.'s BRACAnalysis CDx gained approvals to identify patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated disease for treatment with the drug.

Clovis’ drug was approved initially in late 2016 as monotherapy for the treatment of patients with deleterious BRCA mutation-associated advanced ovarian cancer, who have been treated with two or more chemotherapies.

Clovis has collaborated with Foundation Medicine for a while. In August 2012, the two said they had entered a collaboration to develop an in vitro diagnostic to identify biomarkers to select cancer patients most likely to respond to rucaparib, then in phase I/II clinical development.

Now, with the FDA’s nod, Clovis noted that the objective response rate in BRCA positive patients as determined by Foundationone Liquid CDx was 46% (95% CI, 31-63), which was comparable to 44% (95% CI, 31-57) as determined by clinical trial assays for patients enrolled in TRITON2.

At least one analyst sees promise with this approval. “It is significant that patients now have a plasma-based test in the COVID-19 environment, eliminating scheduling difficulties and invasive procedures associated with tissue-based biopsies,” wrote Edward White with HC Wainwright & Co. “We estimate Rubraca sales of $43.7 [million] in 3Q20, and we estimate FY20 Rubraca sales of $176.0 [million].”

Helping patients, oncologists

While there is great interest in precision cancer care, there are patients who are unable to undergo tissue-based NGS as a result of biopsy tissue being unavailable or biopsy being infeasible. “A noninvasive blood-based option increases access to patients across care settings,” Oxnard explained when asked how the approval could help patients broadly. "Through the availability of a test like this, our hope is that all patients can have access to actionable genomic testing.”

In addition, having tests like Foundationone Liquid CDx could allow more patients to benefit by reducing toxicity and cancer morbidity, all while streamlining care, leading to downstream cost efficiencies.

Looking ahead, Foundation Medicine is hoping to leverage its June acquisition of Lexent Bio, a buy that it expects should lead to an expansion into DNA methylation. "This accelerates Foundation Medicine’s long-term R&D plans by expanding our existing portfolio of offerings for biopharma partners, physicians and patients that help inform treatment decisions at earlier stages of disease,” Oxnard explained.

He added that that company is seeking additional companion diagnostic claims for the test to further enhance its utility in clinical practice.

“Ultimately, our goal is to increase the number of patients getting comprehensive genomic profiling. Now, with two FDA-approved comprehensive genomic profiling tests for tissue and blood with multiple companion diagnostic claims, we’re one step closer to achieving this goal.”

In addition to this week’s news, Foundation Medicine’s Foundationone CDx test was approved this summer as a companion diagnostic to measure tumor mutational burden and help identify patients who may be appropriate for treatment with Merck’s Keytruda (pembrolizumab).

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