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As the most common mutation in HR+/HER2- aBC, it’s important to test for PIK3CA mutations early on during the initial MBC workup.2 With 3 FDA-approved testing modalities, you have multiple options for learning their PIK3CA mutation status.2,3

As patients with PIK3CA mutations face a poor prognosis, it's important to test their status.4
Learn more about the effects of PIK3CA mutations in MBC →

The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
*Following progression on or after an endocrine-based regimen.

2 FDA-approved PIK3CA mutation CDx tests

There are 2 FDA-approved PIK3CA mutation CDx tests available to eligible patients2,3

Select from the options below to learn more about each test.

Foundation Medicine's FoundationOne®CDx and FoundationOne®Liquid CDx are comprehensive genomic profiling (CGP), next-generation sequencing (NGS) multi-gene tests, which include PIK3CA, and provide tissue and plasma testing, respectively.2,3

Multi-gene NGS test from Foundation Medicine

FoundationOne® sample report

FoundationOne®CDx tissue-based

FoundationOne®CDx is a comprehensive genomic profiling (CGP) next-generation sequencing (NGS)-based multi-gene in vitro diagnostic test. FoundationOne®CDx can detect PIK3CA mutations in tissue and is a companion diagnostic for alpelisib.2

SEE TECHNICAL AND SAFETY INFORMATION

FoundationOne®CDx and FoundationOne®Liquid CDx are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries
FoundationOne® CDx sample report

Results can be found on page 1 of the sample report.

Foundation Medicine offers in-home blood draw with mobile phlebotomy through its partner, ExamOne®, to support broader access to FoundationOne®Liquid CDx, at no additional cost.

PIQ advanced breast cancer icon

Foundation Medicine generally expects to provide results in 12 days or less from specimen receipt.

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Multi-gene NGS test from Foundation Medicine 

FoundationOne®Liquid CDx plasma-based test

FoundationOne®Liquid CDx plasma-based

FoundationOne®Liquid CDx is a comprehensive genomic profiling (CGP) next-generation sequencing (NGS)-based multi-gene in vitro diagnostic test. FoundationOne®Liquid CDx can detect PIK3CA mutations in blood and is a companion diagnostic for alpelisib. Foundation Medicine offers the option to automatically reflex between tissue and liquid sample types.3

TECHNICAL AND SAFETY INFORMATION

FoundationOne®CDx and FoundationOne®Liquid CDx are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries12

 

FoundationOne® CDx sample report

Results can be found on page 1 of the sample report. 

Foundation Medicine offers in-home blood draw with mobile phlebotomy through its partner, ExamOne®, to support broader access to FoundationOne®Liquid CDx, at no additional cost.

Novartis is not responsible for any such third-party content that may be accessed via the above provided resources. Novartis does not endorse the content contained in these sites, nor the organizations publishing those sites, and hereby disclaims any responsibility for such content.

PIQ advanced breast cancer icon

Foundation Medicine generally expects to provide results in 12 days or less from specimen receipt.

GO TO FOUNDATION MEDICINE

Important Safety Information

PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.

Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms, including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia...

Indication

PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen...

Click or scroll to see IMPORTANT SAFETY INFORMATION AND INDICATION
References: 1. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70. 2. FoundationOne®CDx technical information. Foundation Medicine, Inc. 3. FoundationOne®Liquid CDx technical information. Foundation Medicine, Inc. 4. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377-386. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 19, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. 6. Burstein H, Somerfield M, Barton D, et al. Endocrine treatment and targeted therapy for hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer: ASCO guideline update. J Clin Oncol. 2021;39(35):3959-3977. 7. Piqray. Prescribing information. Novartis Pharmaceuticals Corp. 8. Data on file. Novartis Pharmaceuticals Corp; 2021. 9. Wu G, Zing M, Mambo E, et al. Somatic mutation and gain of copy number of PIK3CA in human breast cancer. Breast Cancer Res. 2005;7(5):R609-R616. 10. Bettegowda C, Sausen M, Leary RJ, et al. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014;6(224):224ra24. 11. Carraro P, Plebani M. Errors in stat laboratory: types and frequencies 10 years later. Clin Chem. 2007;53(7):1338-1342. 12. Billing and Financial Assistance. Accessed July 6, 2021. https://www.foundationmedicine.com/resource/billing-and-financial-assistance.