FDA批准的精准医疗诊断体外器械一览表List of Cleared or Approved Companion Dia

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

Drug Trade Name

(Generic Name)

Erbitux (cetuximab);

BLA

125084;

DAKO EGFR PharmDx Kit

P030044S001-S002

NDA/BLA

Device Trade Name

PMA

Device

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

Manufacturer

Dako

North

The

EGFR

pharmDx?

assay

is

a

qualitative

America, Inc.

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).

Vectibix

(panitumumab)

BLA 125147

Erbitux (cetuximab); Vectibix

BLA

therascreen

KRAS

RGQ

PCR

P110030

(panitumumab)

125084;BLA

Kit

125147

Qiagen

Manchester,

Ltd.

P110027

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

BLA

The

cobas?

KRAS

Mutation

P140023

(panitumumab)

125084;BLA

Test

125147

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.

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

Exjade

NDA

021882

Ferriscan

K124065

Resonance

Health

Analysis

Services

Pty

(deferasirox)

Gilotrif

NDA

201292

therascreen

EGFR

RGQ

PCR

P120022

Kit

Ltd

Qiagen

Manchester,

Ltd.

patients receiving therapy with deferasirox.

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.

(afatinib)

Gleevec/Glivec

NDA

021335;

DAKO C-KIT PharmDx

P040011S001-S002

Dako

North

The

c-Kit

pharmDX

assay

is

a

qualitative

America, Inc.

immunohistochemical (IHC) kit system used on

the

DakoAutostainer,

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

(imatinibmesylate).

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.

(imatinibmesylate)

NDA

021588

Herceptin

BLA 103792

INFORM HER-2/NEU

P940004S001

Ventana

Medical

Systems, Inc.

(trastuzumab)

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.

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

Herceptin

BLA 103792

HER2 CISH PharmDx Kit

P100024S001-S005

Dako

Denmark A/S

DakoAutostainer instruments.

(trastuzumab)

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.

BLA 103792

PATHWAY

ANTI- HER-2/NEU

P990081S001-S028

(4B5)

Rabbit

Monoclonal

Primary Antibody

Herceptin

Ventana

Medical

Systems, Inc.

Ventana

Medical

Systems’

PA

THWAY

Her2

(clone

CB11)

is

a

mouse

monoclonal

antibody

intended

for

laboratory

use

for

the

semi- quantitative detection of c-erbB-2 antigen

(trastuzumab)

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.

BLA 103792

Bond Oracle Her2 IHC System

P090015S001

Herceptin

Leica

Biosystems

(trastuzumab)

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

BLA 103792

SPOT-LIGHT HER2 CISH Kit

P050040S001-S003

Life

For In Vitro Diagnostic Use.

Technologies,

Inc.

The

SPOT-Light

HER2

CISH

Kit

is

intended

to

quantitatively

determine

HER2

gene

amplification

in

formalin-fixed,

(trastuzumab)

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.

BLA 103792

INSITE HER-2/NEU KIT

P040030

Herceptin

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

(trastuzumab)

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/neuimmunostaining

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.

BLA 103792

INFORM HER2 DUAL ISH DNA

P100027S001-S017

Probe Cocktail

Herceptin

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

VentanaBenchMark

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.

(trastuzumab)

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

BLA 103792

PATHVYSION

Probe Kit

HER-2

DNA

P980024S001-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).

For in vitro diagnostic use.

Herceptin

(trastuzumab);

BLA

103792;

BLA 125409

HERCEPTEST

P980018S001-S018

Dako

Denmark A/S

Perjeta (pertuzumab);

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- trastuzumabemtansine)

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

Kadcyla

(ado-trastuzumabemtansine)

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 DakoHercepTest (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