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U.S. Department of Health and Human Services

Medical Devices

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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.

Click on a column heading to sort the list items.

Drug Trade Name
(Generic Name)
NDA/BLADevice Trade NamePMADevice ManufacturerIntended Use (IU)/ Indications for Use (IFU)
Erbitux (cetuximab)BLA 125084therascreen KRAS RGQ PCR KitP110030Qiagen 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) based on a KRAS no mutation detected test result.
Erbitux (cetuximab);
Vectibix
(panitumumab)
BLA 125084;
BLA 125147
DAKO EGFR PharmDx KitP030044 S001-S002Dako 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 021882FerriscanK124065Resonance Health Analysis Services Pty LtdThe 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 201292therascreen EGFR RGQ PCR KitP120022Qiagen 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 PharmDxP040011 S001-S002Dako 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 103792INFORM HER-2/NEUP940004 S001Ventana 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 103792PATHVYSION HER-2 DNA Probe KitP980024 S001-S010Abbott 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 103792PATHWAY ANTI-HER-2/NEU (4B5) Rabbit Monoclonal Primary AntibodyP990081 S001-S016Ventana 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 103792INSITE HER-2/NEU KITP040030Biogenex 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 103792SPOT-LIGHT HER2 CISH KitP050040 S001-S003Life 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 103792Bond Oracle Her2 IHC SystemP090015Leica BiosystemsThe 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 103792HER2 CISH PharmDx KitP100024 S001-S004Dako Denmark A/SHER2 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 103792INFORM HER2 DUAL ISH DNA Probe CocktailP100027 S001-S006Ventana 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
HERCEPTESTP980018 S001-S017Dako Denmark A/SFor 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 KitP040005 S001-S009Dako Denmark A/SHER2 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 KitP120014bioMérieux 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 021743cobas EGFR Mutation TestP120019Roche 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 metastatic NSCLC for whom Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.
Xalkori (crizotinib)NDA 202570VYSIS ALK Break Apart FISH Probe KitP110012 S001-S003Abbott 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 202429COBAS 4800 BRAF V600 Mutation TestP110020 S001-S006Roche 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.