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Biomedical devices > Case study 1 > Flashcards

Case study 1 Flashcards

1
Q

What are 3 ways biomarkers fail to reach the clinic?

A

Fraud
True discovery leading to weak clinical performance
False discovery leading to original claims failing validation

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2
Q

What was the ovarian cancer trail that failed?

A

Early Detection Research Network
Dr Gil Mor

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3
Q

What did Dr Gil Mor’s trail looked at

A

6-protein panel detected ovarian cancer in only 34% of women diagnosed with disease within a year

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4
Q

What was Dr Gil Mor’s downfall?

A

Inappropriate statistical calculation & unproven claims for the test

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5
Q

Did Ovasure reach marker?

A

Yes for 4 months but FDA intervened

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6
Q

What was Genomic Health’s aim?

A

Development & commercialization of genomic-based clinical diagnostic tests for cancer to allow for individualised treatment decisions

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7
Q

What were 5 subtypes of Genomic health’s mRNA gene-expression profiling studies breast cancer testing?

A

Luminal A - most favourable
ERBB2 (HER2) - poor
Basal like (triple negative) - poor
Luminal B
Normal breast-like

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8
Q

When was genomic health founded?

A

2000 following first major study in 1994

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9
Q

When was Genomics Healtth Proof of concept completed?

A

2001 - demonstrated gene expression profiles from FFPE tumours

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10
Q

What were 5 reference genes in Genomic Health?

A

beta actin
GAPDH
RPLO
GUS
TFRC

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11
Q

What was genomic health’s assay used for?

A

Assess likelihood of recurrence using archived tumour samples from 668 patients with N-tamoxifen treated Bca

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12
Q

What were the 3 recurrence scores?

A

Low risk <18
Intermediate risk 18-25
High risk > 25

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13
Q

When was the Oncotype Dx BC test launched?

A

2004

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14
Q

What did the SWOG 8814 study evaluate?

A

Post-menopausal patients with N+, ER+ BCa treated with chemohormonal tx vs tamoxifen alone

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15
Q

What did SWOG 8814 study find?

A

Chemotx of no benefit in women with low RS despite N+ -> added CHT in intermediate scores of limited value
High RS - large benefit from chemotherapy

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16
Q

What cancers are genomic Health Dx test used for?

A

Breast
Colon
Ductal carcinoma in situ
Prostrate

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17
Q

When did SEER registry recognise the Genomic Health Dx test was effective?

A

2015

18
Q

When did TailorX support the Oncotype Dx for BCa?

A

2015

19
Q

When did the UK recommend Oncotype Dx test by NICE guidelines?

A

2015/2016

20
Q

When can chemotherapy be spared in?

A

70% of BCa Pts with LN-, ER+, HER-2-

21
Q

What did the OncoMasTR Molecular Score look at?

A

3 gene mRNA panel looking at OXM1, PTTG1 and ZNF367

22
Q

What does OMclin1 combine?

A

OMm, tumour size, grade & nodal status

23
Q

What does OMclin2 incorportae?

A

OMm, tumour size & nodal status

24
Q

What were Omm, OMclin1/2 in TransATAC highly prognostic for?

A

early & late DR in 646 women with post-menopausal early-stage ER+ BCa receiving 5 yrs endocrine therapy

25
Q

What was the endocrine therapy in TransATAC?

A

Tamoxifen
Anastrozole

26
Q

Were OMclin1/2 superior to Oncotype Dx RS ?

A

Yes for identifying Pts at increased risk of DR

27
Q

What occurs if you have the V7 of the androgen receptor?

A

sign that pt is becoming resistant to androgen therapy - decreases survival

28
Q

What test is in the Oncotype Dx gene expression panel?

A

Oncotype MAP -Pan cancer tissue test (NGS & IHC)

29
Q

What does the oncotype SEQ liquid biopsy mutation panel have?

A

NGS blood-based test of cfDNA
identifies alterations in panel of 17 genes associated with malignat transformation
late stage solid tumours

30
Q

Who founded theranos?

A

Elizabeth Holmes in 2003

31
Q

What was Theranos aim?

A

lab-on-a-chip technology for blood tests

32
Q

What were 3 pros of theranos?

A

Testing is cheaper
convenient - patients can access reports & takes 4hrs
accessible to customers

33
Q

How many tests can be done in one vial of blood?

A

30

34
Q

What was the machine in theranos for in house invitro testing?

A

Edison machine

35
Q

Who did theranos parther with to open a wellness centre?

A

AmeriHealth Caritas
Capital BlueCross

36
Q

How many tests did theranos offer?

A

> 240 ranging from cholesterol to cancer

37
Q

Did the FDA approve theranos?

A

Yes for HSV-1

38
Q

When did CMS revoke their lab license?

A

2016 & prohibited from operating a lab for 2 years

39
Q

When did the laboratories in Arizona close?Oct

A

2016

40
Q

When did Homes step down & theranos closed?

A

August 31st 2018

Biomedical devices (14 decks)

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