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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.1 With 3 FDA-approved testing modalities, you have multiple options for learning their PIK3CA mutation status.2-4

As patients with PIK3CA mutations face a poor prognosis, it's important to test their status.5
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.

3 FDA-approved PIK3CA mutation CDx tests
There are 3 FDA-approved PIK3CA mutation CDx tests available to eligible patients2-4

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

QIAGEN's therascreen® PIK3CA RGQ PCR Kit is a real-time, qualitative, single-gene, polymerase chain reaction (PCR) test, run on the Rotor-Gene Q MDx (US) system, for the detection of 11 mutations in the PIK3CA gene and provides tissue and plasma testing.2

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.3,4

Single-gene testing (PCR) with the QIAGEN therascreen® PIK3CA RGQ PCR Kit 

QIAGEN therascreen® PIK3CA RGQ PCR Kit

The QIAGEN therascreen® PIK3CA RGQ PCR Kit is an FDA-approved companion diagnostic (CDx) single-gene test for the detection of 11 mutations in the PIK3CA gene using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) isolated from K2EDTA anticoagulated peripheral whole blood plasma taken from patients with breast cancer.2

For more information on using the QIAGEN therascreen® PIK3CA RGQ PCR Kit, please see Instructions for Use (IFU).

SEE IFU

QIAGEN therascreen® PIK3CA RGQ PCR Kit has been verified for both tumor tissue and plasma testing with NeoGenomics Laboratories
PIK3CA mutation testing kit

NeoGenomics is the only lab currently performing testing under the PIK3CA Mutation CDx Testing Program. Alternate labs will process this test outside of the PIK3CA Mutation CDx Testing Program.

To find alternate labs that have verified the QIAGEN therascreen® PIK3CA RGQ PCR Kit, visit the QIAGEN lab finder online or call 1-800-362-7737.

FIND ALTERNATE LAB

Multi-gene NGS test from Foundation Medicine

FoundationOne® CDx tissue-based test

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.3

SEE TECHNICAL AND SAFETY INFORMATION

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

GO TO FOUNDATION MEDICINE 

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.4

TECHNICAL AND SAFETY INFORMATION

FoundationOne®CDx and FoundationOne®Liquid CDx are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries13

 

FoundationOne® 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

Understand your testing options

Need help navigating your options? Let Pik Nav, your informative guide, take you through a short video on available FDA-approved PIK3CA mutation CDx tests.

See more videos →

NeoGenomics Laboratories logo

PIK3CA mutation testing is available to eligible patients at no cost*

Learn more about the free PIK3CA mutation testing program through NeoGenomics.

*Terms and conditions may apply.

 

Mutation matters

View an expert discussion about why PIK3CA mutations matter in HR+/HER2- aBC patients. Dr Dejan Juric discusses mutations with Dr Jules Cohen and Dr Chaitali Nangia.

View more expert videos 

Testing resources
PIK3CA Testing Navigator brochure

BROCHURE

PIK3CA Testing Navigator Brochure

An overview on why, when, and how to test

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 postmenopausal women, and men, 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. QIAGEN therascreen® PIK3CA RGQ PCR Kit Instructions for Use. Germantown, MD: QIAGEN; May 2019. 3. FoundationOne®CDx technical information. Foundation Medicine, Inc. 4. FoundationOne®Liquid CDx technical information. Foundation Medicine, Inc. 5. 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. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 9, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 7. 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. 8. Piqray [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 9. Data on file. Novartis Pharmaceuticals Corp; 2021. 10. 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. 11. 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. 12. Carraro P, Plebani M. Errors in stat laboratory: types and frequencies 10 years later. Clin Chem. 2007;53(7):1338-1342. 13. Billing and Financial Assistance. Accessed July 6, 2021. https://www.foundationmedicine.com/resource/billing-and-financial-assistance.