Medical Devices

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)

A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.

The list of FDA cleared or approved nucleic acid based tests is maintained on a separate page at Nucleic Acid Based Tests.

Drug Trade Name
(Generic Name)
NDA/BLA Device Trade Name PMA Device Manufacturer Intended Use (IU)/ Indications for Use (IFU)
Pembrolizumab BLA125514
(S008 and S012)
PD-L1 IHC 22C3 pharmDx P150013/S001 Dako North America, Inc.

For in vitro diagnostic use.

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances.

TAGRISSO™ (osimertinib) 208065 cobas® EGFR Mutation Test v2 P150044 Roche Molecular Systems, Inc.

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.

The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling.

Table 1 Drug FFPET Plasma
TARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858R
TAGRISSO™ (osimertinib) T790M T790M*

Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

*The efficacy of TAGRISSO™ (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.

Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2.

Table 2 Drug FFPET Plasma
TARCEVA® (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861Q
TAGRISSO™ (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, T790M, S768I, and L861Q

For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.

Tarceva® (erlotinib) 021743 cobas® EGFR Mutation Test v2 P150047 Roche Molecular Systems, Inc.

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.

The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling.

Table 1 Drug FFPET Plasma
TARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858R
TAGRISSO™ (osimertinib) T790M  

Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2.

Table 2 Drug FFPET Plasma
TARCEVA® (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861Q
TAGRISSO™ (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, T790M, S768I, and L861Q

For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.

VENCLEXTA®
(venetoclax)
208573 VYSIS CLL FISH PROBE KIT P150041 ABBOTT MOLECULAR, INC

The Vysis CLL FISH Probe Kit is a test to detect deletion of the LSI TP53 probe target via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

The test is indicated for detecting deletion of the LSI TP53 probe target (17p-) as an aid in identifying those patients with CLL for whom treatment with VENCLEXTA® (venetoclax) is indicated. Vysis CLL FISH Probe Kit is not intended for monitoring of residual disease.

imatinib mesylate NDA 21-335 KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) H140006 ARUP Laboratories, Inc.

KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) (referred to as the "KIT D816V assay") is an in vitro diagnostic test intended for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis. The KIT D816V mutational assay is indicated as an aid in the selection of ASM patients for whom Gleevec® (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.

The indication for use statement has been modified from that granted for the HUD designation. The HUD designation was for use in skin or bone marrow biopsies. It was modified for the HDE approval to limit the assay use to fresh bone marrow biopsies.

imatinib mesylate NDA 21-335 PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD) H140005 ARUP Laboratories, Inc.

The PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/ Myeloproliferative Disease (MDS/MPD) is an in vitro diagnostic test intended for the qualitative detection of PDGFRB gene rearrangement from fresh bone marrow samples of patients with MDS/MPD with a high index of suspicion based on karyotyping showing a 5q31~33 anomaly. The PDGFRB FISH assay is indicated as an aid in the selection of MDS/MPD patients for whom Gleevec®(imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.

The indication for use statement has been modified from that granted for the HUD designation. The HUD designation was for use in both peripheral blood and bone marrow specimens. It was modified for the HDE approval to indicate that only fresh bone marrow samples may be used.

Tagrisso® (osimertinib) NDA 208065 cobas® EGFR Mutation Test v2 P120019 S007 Roche Molecular Systems, Inc.

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from non-small cell lung cancer (NSCLC) patients. The test is intended to aid in identifying patients with NSCLC whose tumors have defined EGFR mutations and for whom safety and efficacy of a drug have been established as follows:

  • Tarceva® (erlotinib) - Exon 19 deletions and L858R
  • Tagrisso® (osimertinib) - T790M

Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2:

  • Tarceva® (erlotinib) - G719X, exon 20 insertions, T790M, S768I and L861Q
  • Tagrisso® (osimertinib) - G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q

For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and the cobas z 480 analyzer is used for automated amplification and detection.

KEYTRUDA® (pembrolizumab) BLA 125514/s-5 PD-L1 IHC 22C3 pharmDx P150013 Dako, North America, Inc.

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered PD-L1 positive if TPS ≥ 50% of the viable tumor cells exhibit membrane staining at any intensity.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab).

Iressa (gefitinib) NDA 206995 therascreen® EGFR RGQ PCR Kit P120022 S001 Qiagen Manchester, Ltd.

The therascreen® EGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF® (afatinib) or IRESSA® (gefitinib), EGFR tyrosine kinase inhibitors (TKIs), is indicated. Safety and efficacy of GILOTRIF (afatinib) and IRESSA (gefitinib) have not been established in the patients whose tumors have L861Q, G719X, S768I, exon 20 insertions, and T790M mutations, which are also detected by the therascreen EGFR RGQ PCR Kit.

Specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q MDx instrument for automated amplification and detection.

Xalkori (crizotinib) NDA 202570 VENTANA ALK (D5F3) CDx Assay P140025 Ventana Medical Systems, Inc. VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib).
Erbitux (cetuximab); Vectibix (panitumumab) BLA 125084; BLA 125147 The cobas® KRAS Mutation Test P140023 Roche Molecular Systems, Inc. The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of seven somatic mutations in codons 12 and 13 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients for whom treatment with Erbitux® (cetuximab) or with Vectibix® (panitumumab) may be indicated based on a no mutation detected result. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
Lynparza™ (olaparib) NDA 206162 BRACAnalysis CDx™ P140020 Myriad Genetic Laboratories, Inc. BRACAnalysis CDx™ is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza™ (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.
Erbitux (cetuximab); Vectibix (panitumumab) BLA 125084; BLA 125147 therascreen KRAS RGQ PCR Kit P110030
P110027
Qiagen Manchester, Ltd. The therascreen KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue.  The therascreen KRAS RGQ PCR Kit is intended to aid in the identification of CRC patients for treatment with Erbitux (cetuximab) and Vectibix (panitumumab) based on a KRAS no mutation detected test result.
Erbitux (cetuximab);
Vectibix
(panitumumab)
BLA 125084;
BLA 125147
DAKO EGFR PharmDx Kit P030044 S001-S002 Dako North America, Inc. The EGFR pharmDx™ assay is a qualitative immunohistochemical (IHC) kit system to identify epidermal growth factor receptor (EGFR) expression in normal and neoplastic tissues routinely-fixed for histological evaluation EGFR pharmDx specifically detects the EGFR (HER1) protein in EGFR-expressing cells.

EGFR pharmDx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).
Exjade
(deferasirox)
NDA 021882 Ferriscan K124065 Resonance Health Analysis Services Pty Ltd The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non-transfusion dependent thalassemia patients receiving therapy with deferasirox.
Gilotrif
(afatinib)
NDA 201292 therascreen EGFR RGQ PCR Kit P120022 Qiagen Manchester, Ltd. The therascreen EGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated. Safety and efficacy of GILOTRIF (afatinib) have not been established in patients whose tumors have L861Q, G719X, S768I, exon 20 insertions, and T790M mutations, which are also detected by the therascreen EGFR RGQ PCR Kit.
Specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q MDx instrument for automated amplification and detection.
Gleevec/Glivec
(imatinib mesylate)
NDA 021335;
NDA 021588
DAKO C-KIT PharmDx P040011 S001-S002 Dako North America, Inc. The c-Kit pharmDX assay is a qualitative immunohistochemical (IHC) kit system used on the Dako Autostainer, for the identification of c-kit protein/CD 117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-Kit pharmDX rabbit polyclonal antibodies specifically detect the c-kit protein in CD 117 antigen-expressing cells.

The c-Kit pharmDx is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-Kit pharmDx may be used as an aid in identifying those patients eligible for treatment with Gleevec/Glivec (imatinib mesylate).
Results from hematoxylin and eosin (H&E) stains and a panel of antibodies can aid in the differential diagnosis of GIST. Interpretation must be made by a qualified pathologist, within the context of a patient's clinical history, proper controls, and other diagnostic tests.
Herceptin
(trastuzumab)
BLA 103792 INFORM HER-2/NEU P940004 S001 Ventana Medical Systems, Inc. The Inform Her-2/Neu gene detection system is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of Her-2/Neu gene amplification on formalin-fixed, paraffin embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priori invasive, localized breast carcinoma and who are lymph node-negative.
Herceptin
(trastuzumab)
BLA 103792 PATHVYSION HER-2 DNA Probe Kit P980024 S001-S012 Abbott Molecular Inc. The PathVysion HER-2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion Kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion Kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The Pathvysion Kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
Herceptin
(trastuzumab)
BLA 103792 PATHWAY ANTI-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody P990081 S001-S028 Ventana Medical Systems, Inc. Ventana Medical Systems’ PATHWAY Her2 (clone CB11) is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbB-2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is being considered.
Herceptin
(trastuzumab)
BLA 103792 INSITE HER-2/NEU KIT P040030 Biogenex Laboratories, Inc. InSite Her-2/neu Mouse Monoclonal Antibody (Clone C1B11) kit is intended for In Vitro Diagnostic use in Immunohistochemistry (IHC) assays to semi-quantitatively localize by light microscopy the over-expression of Her-2/neu (i.e., c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue sections. InSite Her-2/neu is indicated as an aid in the assessment of breast cancer patients for whom Herceptin (Trastuzumab) therapy is being considered. Clinical interpretation of InSite Her-2/neu immunostaining results (absence or presence; semi-quantitative intensity score) should be complemented by appropriate controls and morphological tissue analysis and be evaluated by a qualified pathologist within the context of patient clinical history and other diagnostic results.
Herceptin
(trastuzumab)
BLA 103792 SPOT-LIGHT HER2 CISH Kit P050040 S001-S003 Life Technologies, Inc. For In Vitro Diagnostic Use.

The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections using Chromogenic In Situ Hybridization (CISH) and brightfield microscopy.

This test should be performed in a histopathology laboratory.

The SPOT-Light HER2 CISH Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. The assay results are intended for use as an adjunct to the clinicopathological information currently being used as part of the management of breast cancer patients. Interpretation of test results must be made within the context of the patient's clinical history by a qualified pathologist.
Herceptin
(trastuzumab)
BLA 103792 Bond Oracle Her2 IHC System P090015 S001 Leica Biosystems The Bond Oracle Her2 IHC system is a semi-quantitative immunohistochemical (IHC) assay to determine Her2 (human epidermal growth factor receptor 2) oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue processed for histological evaluation following automated staining on the bond-max slide staining instrument. The Bond Oracle Her2 IHC system is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered.
Herceptin
(trastuzumab)
BLA 103792 HER2 CISH PharmDx Kit P100024 S001-S005 Dako Denmark A/S HER2 CISH PharmDx kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments.

HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

This kit is for in vitro diagnostic (IVD) use only.
Herceptin
(trastuzumab)
BLA 103792 INFORM HER2 DUAL ISH DNA Probe Cocktail P100027 S001-S017 Ventana Medical Systems, Inc. The INFORM HER2 Dual ISH DNA Probe Cocktail is intended for use in determining HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on Ventana BenchMark XT automated slide stainers (using NexES software), by light microscopy. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.

This reagent is intended for in vitro diagnostic (IVD) use.
Herceptin
(trastuzumab);
Perjeta (pertuzumab);
Kadcyla
(ado-trastuzumab emtansine)
BLA 103792;
BLA 125409
HERCEPTEST P980018 S001-S018 Dako Denmark A/S For in vitro diagnostic use.

HercepTest is a semi-quantitative immunocytochemical assay to determine HER2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA (pertuzumab) treatment or KADCYLA (ado-trastuzumab emtansine) treatment is being considered (see Herceptin, PERJETA and KADCYLA package inserts).

NOTE for breast cancer only: All of the patients in the Herceptin clinical trials were selected using an investigational immunocytochemical clinical trial assay (CTA). None of the patients in those trials were selected using the HercepTest. The HercepTest was compared to the CTA on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the HercepTest to Herceptin clinical outcome has not been established.

NOTE for gastric cancer only: All of the patients in the phase III BO18255 (ToGA) study sponsored by Hoffmann-La Roche were selected using Dako HercepTest (IHC) and Dako HER2 FISH pharmDx™ Kit (FISH). However, enrollment in the BO18255 study was limited to patients whose tumors were HER2 protein overexpressing (IHC 3+) or gene amplified (FISH+; HER2/CEN-17 ratio ≥ 2.0). No patients were enrolled whose tumors were not gene amplified but HER2 protein weakly to strongly overexpressing [FISH(-)/IHC 2+], therefore it is unclear if patients whose tumors are not gene amplified but HER2 protein overexpressing [i.e., FISH(-), IHC 2+ or 3+] will benefit from Herceptin treatment. The study also demonstrated that gene amplification and protein overexpression (IHC) are not as correlated as with breast cancer, therefore a single method should not be used to determine HER2 status.
Herceptin
(trastuzumab);
Perjeta (pertuzumab);
Kadcyla (ado-trastuzumab emtansine)
BLA 103792;
BLA 125409
HER2 FISH PharmDx Kit P040005 S001-S010 Dako Denmark A/S HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma.

HER2 IQFISH pharmDx is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin (trastuzumab) treatment is being considered and for breast cancer patients for whom Perjeta (pertuzumab) or Kadcyla (ado-trastuzumab emtansine) treatment is being considered (see Herceptin, Perjeta and Kadcyla package inserts).

For breast cancer patients, results from the HER2 IQFISH pharmDx are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
Mekinist (tramatenib); Tafinlar (dabrafenib) NDA 204114;
NDA 202806
THxID™ BRAF Kit P120014 bioMérieux Inc. The THxID BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The THxID™ BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].
Tarceva (erlotinib) NDA 021743 cobas EGFR Mutation Test P120019 S001-S004 Roche Molecular Systems, Inc. The cobas® EGFR Mutation Test is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) human non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used as an aid in selecting patients with NSCLC for whom Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.
Xalkori (crizotinib) NDA 202570 VYSIS ALK Break Apart FISH Probe Kit P110012 S001-S003 Abbott Molecular Inc. The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying patients eligible for treatment with Xalkori (crizotinib). This is for prescription use only.
Zelboraf (vemurafenib) NDA 202429 COBAS 4800 BRAF V600 Mutation Test P110020 S001-S010 Roche Molecular Systems, Inc. The Cobas 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The Cobas 4800 BRAF V600 Mutation Test is a real-time PCR test on the Cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.

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