CDx Resources

This is for US residents only.

PIK3CA Mutation CDx testing channels

 

NeoGenomics PIK3CA Mutation CDx Testing

Appropriate patients may receive one free PIK3CA mutation test result with the PIK3CA Mutation CDx Testing Program through NeoGenomics.

OR

Alternate lab for PIK3CA Mutation CDx Testing

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

OR

Verify PIK3CA Mutation CDx in your lab

Order the kit and verify this test for your lab with QIAGEN.

CDx Testing Program

PIK3CA Mutation CDx Test through NeoGenomics

The PIK3CA Mutation Companion Diagnostic (CDx) Testing Program is designed to provide access to PIK3CA mutation testing for appropriate HR+/HER2- advanced breast cancer patients.

Appropriate patients may receive one free PIK3CA mutation test using an FDA-approved test of record 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. No patient, health care program, or beneficiary shall be billed for this mutation test.

PIK3CA Mutation CDx Test Request Form

PIK3CA CDx Testing Program Order Form

NeoGenomics Customer Services NeoGenomics Customer Services

 

Want to use a different lab?

Discover the labs that have verified the PIK3CA Mutation Companion Diagnostic.

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

 

 

Verify the test in your lab

The QIAGEN therascreen® PIK3CA Rotor-Gene Q (RGQ) PCR Kit

therascreen® PIK3CA Rotor-Gene Q (RGQ) PCR Kit therascreen® PIK3CA Rotor-Gene Q (RGQ) PCR Kit

 

The QIAGEN therascreen® PIK3CA RGQ PCR Kit is a real-time qualitative PCR assay.

Tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q MDx (US) instrument is used for automated amplification and detection. It is to be used by trained personnel in a professional laboratory environment.

DNA should be extracted using the QIAamp DSP DNA FFPE Tissue Kit (catalog number 60404) DNA should be extracted using the QIAamp DSP DNA FFPE Tissue Kit (catalog number 60404)
 

Verify the test through QIAGEN

Connect with QIAGEN to bring the PIK3CA Mutation CDx into your lab.

 

Reimbursement

Tier 1 CPT code will be available in the future. For more information, go to CMS.gov.

 
Tier 1
Tier 2
CPT code
Coming soon
81404
81479
Descriptor
Any single-gene PIK3CA Mutation test
Molecular pathology procedure, Level 5
Unlisted molecular pathology procedure

Utilization of any code listed is not a guarantee of coverage or reimbursement. Novartis provides this for informational purposes only.

 

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, were reported in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.

Severe Cutaneous Reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and erythema multiforme (EM) were reported. Do not initiate PIQRAY treatment in patients with a history of SJS, EM, or toxic epidermal necrolysis (TEN). Interrupt PIQRAY if signs or symptoms of severe cutaneous reactions are present (eg, a prodrome of fever, flu-like symptoms, mucosal lesions or progressive skin rash), until etiology of the reaction has been determined. Advise patients of the signs and symptoms of severe cutaneous reactions. Consider consultation with a dermatologist. Permanently discontinue PIQRAY if SJS, EM, or TEN is confirmed.

Hyperglycemia: Severe hyperglycemia, including ketoacidosis, was reported. Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor blood glucose and/or FPG 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. Initiate or optimize antihyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue PIQRAY if severe hyperglycemia occurs. 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 history of diabetes mellitus may require intensified diabetic treatment. Closely monitor patients with diabetes.

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, has been reported in patients treated with PIQRAY. Monitor for clinical symptoms or radiological changes. Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific 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. Interrupt or discontinue PIQRAY if severe pneumonitis occurs. Advise patients to immediately report new or worsening respiratory symptoms.  

Diarrhea: Severe cases of diarrhea, including dehydration and acute kidney injury, have been reported. Based on the severity of the diarrhea, 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.

Embryo-Fetal Toxicity: PIQRAY and fulvestrant can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. Also, refer to Full Prescribing Information of fulvestrant for pregnancy and contraception information.

Most common adverse reactions, including laboratory abnormalities (all grades, incidence ≥20%) were glucose increased (79%), creatinine increased (67%), diarrhea (58%), rash (52%), lymphocyte count decreased (52%), gamma glutamyl transferase increased (52%), nausea (45%), alanine aminotransferase increased (44%), fatigue (42%), hemoglobin decreased (42%), lipase increased (42%), decreased appetite (36%), stomatitis (30%), vomiting (27%), weight decreased (27%), calcium decreased (27%), glucose decreased (26%), activated partial thromboplastin time  prolonged (21%), and alopecia (20%).

Please click here for full Prescribing Information.

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