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Biomedical devices > Companion Diagnostics > Flashcards

Companion Diagnostics Flashcards

1
Q

Why is treatment success so low?

A

Patients respond differently
disease develops resistance

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2
Q

What is TI ratio?

A

Ratio of effective dose to toxic dose

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3
Q

What are biologics?

A

new drugs based on cell or animal products eg mAb, genetic therapies

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4
Q

What is a companion diagnostic?

A

Device which is essential for the safe & effective use of a corresponding medicinal product

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5
Q

What do companion diagnostics identify?

A

Pts who are most likely to benefit from therapy
Pts most likely to be at increased risk for serious adverse reactions due to treatment

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6
Q

What is theranostics?

A

Combining diagnosis & targeting appropriate therapy

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7
Q

What is the difference between CDXs & complementary diagnostics?

A

CDx - connected to a specfici drug
Complementary - associated more broadly with an entire class of drugs

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8
Q

What is the MoA of nivolumab?

A

PD-L1blocker - inhibits immune evasion of tumour cells

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9
Q

What is a pharmacological profile?

A

Determine acute toxicity of the drug in cell/organoid model

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10
Q

What are 5 different types of clinical trails?

A

Treatment
Prevention
Diagnostic
Screening
QoL

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11
Q

What is the purpose of phase I?

A

Test drug in a small group to evaluate safety

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12
Q

What ios the purpose of phase II/

A

Larger group to test efficacy & further test safety

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13
Q

What is the purpose of phase III?

A

Large groups to confirm efficacy, compare to common treatments, S/Es

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14
Q

What is the purpose of phase IV?

A

Effectiveness in public

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15
Q

What cohort is companion dx used?

A

Select people that have target & are most likely to respond to treatment

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16
Q

What are 2 types of trials?

A

Umbrella - impact of different drugs on different mutations in one cancer type
Basket - effect of one or more drugs on one or more mutations in a variety of cancers

17
Q

What are 3 Companion Dx product services?

A

Kits for lab customers
Lab-developed tests
Analyte specific reagents

18
Q

What can we look at by measuring cytochrome P450 enzymes?

A

Class of proteins to metabolise drugs
Fast/slow metaboliser = more/less of drug
Cannot metabolise than should not receive drug

19
Q

How does CYP2D6 metabolism affect codeine treatment?

A

Increased CYP2D6 function = need high morphine administration

20
Q

What was the first predictive biomarker used for cancer?

A

ER testing by tissue IHC (Cdx) to identify individuals with BCa for tamoxifen treatment

21
Q

What is the MoA of tamoxifen?

A

Competes with endogenous oestrogens for ER in cytosol –> lowers transcription of oestrogen-responsive genes

22
Q

What is Herceptin used for?

A

BC overexpressing HER2

23
Q

What is HER2 +ve BC?

A

Constitutively on growth factor signalling - cancer proliferation

24
Q

What type of mAB is trastuzumab?

A

Humanised murine monoclonal antibody

25
Q

What is the MoA of Trastuzumab?

A

Binds to HER2/ERBB2 -> blocks signaling, triggers immune response, HER2 dimers endocytosised

26
Q

What family is the human EGFR2 part of?

A

Wider family of receptors with intergral tyrosine kinase activity

27
Q

What drug is trastuzumab given with?

A

Taxane

28
Q

What is the CDx test for HER2?

A

Immunostaining (subjective scale)
FISH (more accurate)

29
Q

What do oncologia’s device (Oncofocus) look at?

A

Test for all types of 505 DNA/RNA tumour gene variants

30
Q

What gene variants does Oncofocus look at?

A

CNV
gene fusions
oncogene
TSG mutations
deletions

31
Q
A
32
Q

What is polyneuropathy caused by?

A

hereditary transthyretin mediated amyloidosis

33
Q

What is the Cdx for haTTR?

A

TTR gene mutation analysis

34
Q

What % of trials are using Cdxs?

A

50%

Biomedical devices (14 decks)

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