theragenomics: companion tests

Here, you find the actual compilation of FDA-approved companion tests that provide information essential for the safe and effective use of a corresponding therapeutic product in given patient subgroups, a hallmark of theragenomic medicine.

According to the FDA definition, a  companion diagnostic device can be an 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 page was last updated on December 22, 2016

   

Drug (Generic) Name


NDA/BLA


Device
Trade Name


PMA


Device
Manufacturer


Intended
Use (IU)/ Indications for Use (IFU)


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.


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


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.


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.


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.


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).


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.


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].


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.


Rubraca


209115


FoundationFocus
CDx
BRCA
Assay


P160018


Foundation
Medicine, Inc.



For
in vitro diagnostic use.


The
FoundationFocus™ CDx
BRCA
is a next generation sequencing based
in
vitro

diagnostic device for qualitative detection of
BRCA1
and
BRCA2
alterations in formalin-fixed paraffin-embedded (FFPE) ovarian
tumor tissue. The FoundationFocus CDx
BRCA
assay detects sequence alterations in
BRCA1
and
BRCA2
(
BRCA1/2)
genes. Results of the assay are used as an aid in identifying
ovarian cancer patients for whom treatment with Rubraca™
(rucaparib) is being considered. If a patient is positive for any
of the deleterious alterations specified in the
BRCA1/2
classification, the patient may be eligible for treatment with
Rubraca. This assay is to be performed at Foundation Medicine,
Inc., a single laboratory site located at 150 Second Street,
Cambridge, MA 02141.


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 DrugFFPETPlasma
TARCEVA®
(erlotinib)Exon 19 deletions and L858RExon 19 deletions and
L858RTAGRISSO™ (osimertinib)T790MT790M*
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 DrugFFPETPlasma
TARCEVA®
(erlotinib)G719X, exon 20 insertions, T790M, S768I and L861QG719X,
exon 20 insertions, T790M, S768I and L861QTAGRISSO™
(osimertinib)G719X, exon 19 deletions, L858R, exon 20 insertions,
S768I, and L861QG719X, 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.


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.


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.


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 DrugFFPETPlasma
TARCEVA®
(erlotinib)Exon 19 deletions and L858RExon 19 deletions and
L858RTAGRISSO™ (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 DrugFFPETPlasma
TARCEVA®
(erlotinib)G719X, exon 20 insertions, T790M, S768I and L861QG719X,
exon 20 insertions, T790M, S768I and L861QTAGRISSO™
(osimertinib)G719X, exon 19 deletions, L858R, exon 20 insertions,
S768I, and L861QG719X, 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.


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).


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.


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.