FDA-approved CDx tests
There are 3 FDA-approved PIK3CA mutation CDx tests available to eligible patients1-3:
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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 (RGQ) system, for the detection of 11 mutations in the PIK3CA gene and provides tissue and plasma testing
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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 blood-based testing, respectively
PIK3CA Mutation CDx Testing Program through NeoGenomics
NeoGenomics Laboratories will conduct tumor tissue and plasma testing using the QIAGEN therascreen® PIK3CA RGQ PCR Kit.1 Appropriate patients may receive one tumor tissue or plasma PIK3CA mutation test at no cost for the purpose of determining whether or not the patient has a PIK3CA mutation and is eligible for alpelisib for an FDA-approved indication, without regard to purchase of any prescribed drug or any other product.
If the patient tests negative for a PIK3CA mutation using plasma, eligible patients may also receive one PIK3CA reflex tissue test at no cost. No patient, health care program, or beneficiary shall be billed for this mutation test.
If no mutation is detected in a plasma specimen, retest the patient with tumor tissue.
No patient, health care program, or beneficiary shall be billed for this mutation test. The test shall not be included in a bundled payment to any health care facility including, but not limited to, a hospital. The ordering physician shall not be compensated any fees in connection with this mutation testing, such as for specimen collection, handling, or data reporting. Program is not valid where prohibited by law. Novartis reserves the right to rescind, revoke, or amend the program without notice.
To learn more about the PIK3CA Mutation CDx Testing Program, download the brochure.
Order test through NeoLINK®
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 an alternate lab, please click on the Find Alternate Lab (PCR) tab above.
*This is an external website independently operated and not managed by Novartis Pharmaceuticals Corporation. Novartis assumes no responsibility for the site.
Multi-gene NGS test from Foundation Medicine
FoundationOne®CDx (tissue-based)2
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.
FoundationOne®Liquid CDx (blood-based)3
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.
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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.
Find an alternate lab for PCR single-gene testing
Find an alternate lab that has verified the QIAGEN therascreen® PIK3CA RGQ PCR 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 an alternate lab that has verified the QIAGEN therascreen® PIK3CA RGQ PCR Kit, visit QIAGEN.com/PIK3CA-lab-finder or call 1-800-362-7737.
Verify the QIAGEN PCR test in your lab1
QIAGEN therascreen® PIK3CA RGQ PCR Kit
The QIAGEN therascreen® PIK3CA RGQ PCR Kit is a single-gene real-time qualitative PCR assay.
Tissue kit
Tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The kit is to be used by trained personnel in a professional laboratory environment.
Plasma kit
Plasma specimens are processed using the QIAamp® DSP Circulating NA Kit for manual sample preparation and the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The kit is to be used by trained personnel in a professional laboratory environment.
PIK3CA Testing Navigator brochure
The PIK3CA Testing Navigator brochure provides key information on why, when, and how to test for PIK3CA mutations. It also includes guidance on the PIK3CA Mutation CDx Testing Program through NeoGenomics using the QIAGEN's therascreen® PIK3CA RGQ PCR Kit, as well as information on Foundation Medicine's FoundationOne®CDx and FoundationOne®Liquid CDx.
Download here
PIK3CA CDx Testing Program brochure
The PIK3CA CDx Testing Program brochure describes the guidelines for the CDx Testing Program through NeoGenomics using the therascreen® PIK3CA RGQ PCR Kit. It contains information on ordering a tissue or plasma test via NeoLINK®* and also has a printable fax form.
*This is an external website independently operated and not managed by Novartis Pharmaceuticals Corporation. Novartis assumes no responsibility for the site.
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.
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. The incidence of grade 3 and 4 hypersensitivity reactions was 0.7%. Angioedema has been reported in the postmarketing setting in patients treated with PIQRAY. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.
Severe Cutaneous Adverse Reactions (SCARs): SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur in patients treated with PIQRAY. In the SOLAR-1 study, SJS and EM were reported in 0.4% and 1.1% of patients, respectively. DRESS was reported in patients in the postmarketing setting. If signs or symptoms of SCARs occur, interrupt PIQRAY until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended.
If a SCAR is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patients who have experienced previous SCARs during PIQRAY treatment. If it is not confirmed, PIQRAY may require dose modifications, topical corticosteroids, or oral antihistamine treatment.
Advise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy).
Hyperglycemia: Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis has occurred in patients treated with PIQRAY. Fatal cases of ketoacidosis have occurred in the postmarketing setting.
Hyperglycemia was reported in 65% of patients treated with PIQRAY. Grade 3 (FPG >250-500 mg/dL) and grade 4 (FPG >500 mg/dL) hyperglycemia were reported in 33% and 3.9% of patients, respectively. Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY.
Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor fasting glucose (FPG or fasting blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Monitor fasting glucose more frequently for the first few weeks during treatment in patients with risk factors for hyperglycemia such as obesity (BMI ≥30), elevated FPG, HbA1c at the upper limit of normal or above, use of concomitant systemic corticosteroids, or age ≥75.
If a patient experiences hyperglycemia after initiating treatment, monitor fasting glucose as clinically indicated, and at least twice weekly until fasting glucose decreases to normal levels. During treatment with anti-hyperglycemic medication, continue monitoring fasting glucose at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. Consider consultation with a health care practitioner with expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes.
The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established as these patients were excluded from the SOLAR-1 trial. Patients with a medical history of controlled type 2 diabetes were included. Patients with a history of diabetes mellitus may require intensified hyperglycemic treatment. Closely monitor patients with diabetes.
Based on the severity of the hyperglycemia, PIQRAY may require dose interruption, reduction, or discontinuation. Advise patients of the signs and symptoms of hyperglycemia (eg, excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss).
Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, can occur in patients treated with PIQRAY. Pneumonitis was reported in 1.8% of patients treated with PIQRAY.
In patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis, interrupt PIQRAY immediately and evaluate the patient for pneumonitis. Consider a diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations.
Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms.
Diarrhea or Colitis: Severe diarrhea, resulting in dehydration and in some cases in acute kidney injury, can occur in patients treated with PIQRAY. Most patients (58%) experienced diarrhea during treatment with PIQRAY. Grade 3 diarrhea occurred in 7% (n=19) of patients. Colitis has been reported in the postmarketing setting in patients treated with PIQRAY. Monitor patients for diarrhea and additional symptoms of colitis, such as abdominal pain and mucus, or blood in the stool. Based on the severity of the diarrhea or colitis, PIQRAY may require dose interruption, reduction, or discontinuation. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their health care provider if diarrhea occurs while taking PIQRAY. For patients with colitis, additional treatment, such as enteric-acting and/or systemic steroids, may be required.
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, PIQRAY can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with PIQRAY and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use condoms and effective contraception during treatment with PIQRAY and for 1 week after the last dose. Refer to the full Prescribing Information of fulvestrant for pregnancy and contraception information.
The most common adverse reactions (all grades, incidence ≥20%) were diarrhea (58%), rash (52%), nausea (45%), fatigue (42%), decreased appetite (36%), stomatitis (30%), vomiting (27%), weight decreased (27%), and alopecia (20%). The most common grade 3/4 adverse reactions (incidence ≥2%) were rash (20%), diarrhea (7%), fatigue (5%), weight decreased (3.9%), nausea (2.5%), stomatitis (2.5%), and mucosal inflammation (2.1%).
The most common laboratory abnormalities (all grades, incidence ≥20%) were glucose increased (79%), creatinine increased (67%), lymphocyte count decreased (52%), gamma-glutamyl transferase (GGT) increased (52%), alanine aminotransferase (ALT) increased (44%), hemoglobin decreased (42%), lipase increased (42%), calcium decreased (27%), glucose decreased (26%), and activated partial thromboplastin time (aPTT) prolonged (21%). The most common grade 3/4 laboratory abnormalities (incidence ≥5%) were glucose increased (39%), GGT increased (11%), lymphocyte count decreased (8%), lipase increased (7%), and potassium decreased (6%).
Please click here for full Prescribing Information.
therascreen is a registered trademark of QIAGEN Group.
QIAamp is a registered trademark of QIAGEN Group.
NeoLINK is a registered trademark of NeoGenomics Laboratories, Inc.
ExamOne is a registered trademark of Quest Diagnostics.
Foundation Medicine, FoundationOne CDx, and FoundationOne Liquid CDx are registered trademarks of Foundation Medicine, Inc.
References: 1. therascreen® PIK3CA RGQ PCR Kit Instructions for Use. Germantown, MD: QIAGEN; May 2019. 2. FoundationOne®CDx technical information. Foundation Medicine, Inc. 3. FoundationOne®Liquid CDx technical information. Foundation Medicine, Inc. 4. Billing and Financial Assistance. Accessed November 19, 2020. https://www.foundationmedicine.com/resource/billing-and-financial-assistance.
