PIK3CA Mutation CDx Testing Program through NeoGenomics
Mutation testing with the QIAGEN therascreen® PIK3CA RGQ PCR Kit
NeoGenomics Laboratories will conduct plasma and tissue testing using the QIAGEN therascreen® PIK3CA RGQ PCR test, a real-time qualitative PCR assay for the detection of 11 mutations in the PIK3CA gene. The PIK3CA Mutation CDx Testing Program is designed to provide access to the PIK3CA Mutation Test for appropriate HR+/HER2-/advanced breast cancer patients.
Appropriate patients may receive one free plasma and/or tumor tissue test using the QIAGEN therascreen® PIK3CA RGQ PCR test 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 PIK3CA mutation using plasma, eligible patients may also receive one free PIK3CA reflex tissue test. No patient, health care program, or beneficiary shall be billed for these mutation tests.
If no mutation is detected in a plasma specimen, test tumor tissue.
PIK3CA Mutation CDx Test Request Form–Tumor Tissue
Pre-qualify when ordering PIK3CA mutation CDx plasma tests
Plasma sample pre-qualification is required. Please call 1-866-776-5907 to review test information and special sample collection/handling requirements with NeoGenomics Client Services before arranging patient's blood draw.
PIK3CA Mutation CDx Testing Program: Plasma and Tissue Flashcard
This flashcard describes the PIK3CA Mutation CDx Testing Program, which provides a free plasma and/or tissue test for PIK3CA mutations in eligible patients, with an explanation of how to order the tests.
Discover alternate labs that have verified the QIAGEN therascreen® PIK3CA RGQ PCR Kit
NeoGenomics is the only lab currently performing testing under the CDx Testing Program. Alternate labs will process this test outside of the CDx Testing Program.
Verify the QIAGEN PCR Test in your lab1
The QIAGEN therascreen® PIK3CA Rotor-Gene Q (RGQ) PCR Kit
The QIAGEN therascreen® PIK3CA RGQ CDx 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. The kit is to be used by trained personnel in a professional laboratory environment.
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.
Verify the therascreen® PIK3CA RGQ PCR Kit through QIAGEN
Connect with QIAGEN to bring the therascreen® PIK3CA RGQ PCR Kit into your lab.
FoundationOne®CDx is a next-generation sequencing-based in vitro diagnostic device.
FoundationOne®CDx can detect PIK3CA mutations and is a companion diagnostic for alpelisib.
Order FoundationOne®CDx to learn your patient's PIK3CA mutation status.
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. The incidence of grade 3 and 4 hypersensitivity reactions was 0.7%. 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 in patients treated with PIQRAY. SJS and EM were reported in 0.4% and 1.1% of patients, respectively. Do not initiate PIQRAY treatment in patients with a history of SJS, EM, or toxic epidermal necrolysis (TEN). If signs or symptoms of severe cutaneous reactions occur, interrupt PIQRAY until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended.
If SJS, TEN, or EM is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patients who have experienced previous severe cutaneous reactions 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 severe cutaneous reactions (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, or progressive skin rash).
Hyperglycemia: Severe hyperglycemia, including ketoacidosis, has been reported in patients treated with PIQRAY. 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 was 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 FPG, HbA1c, and optimize blood glucose. After initiating treatment with PIQRAY, 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. If a patient experiences hyperglycemia after initiating treatment with PIQRAY, monitor blood glucose and/or FPG as clinically indicated, and at least twice weekly until blood glucose or FPG decreases to normal levels. During treatment with antidiabetic medication, continue monitoring blood glucose or FPG 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 type 2 diabetes were included. Patients with a history of diabetes mellitus may require intensified diabetic 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, has been reported 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 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.
Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms.
Diarrhea: Severe diarrhea, including dehydration and acute kidney injury, occurred in patients treated with PIQRAY. Most patients (58%) experienced diarrhea during treatment with PIQRAY. Grade 3 diarrhea occurred in 7% (n=19) of patients. 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: 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%), and 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.
Foundation Medicine and FoundationOne 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 Summary of Safety and Effectiveness [draft] P170019/S006.