Cytosponge timeline
Category: Other
Updated: 11 Jan 2023
MEDC0107 coursework
Contributors
Created by Polly Hung
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Rebecca C Fitzgerald designed
non-endoscopic sampler when
she was at MRC Cancer unit in
the University of Cambridge. > Feasibility study for Cytosponge
1. 80% of patients prefer cytosponge
over endoscopy
2. 94.8% of samples were adequate
for analysis
3. Sensitivity and specificity fluctuates
around 70%, give and take
experiment biases. > Identify a good Biomarker.
TFF3 (Trefoil factor 3) is a promising
biomarker for Barrett's Oesophagus
diagnosis. It can be applied to a non-
endoscopic screening device. > Patent
Biomarker for Barrett's Oesophagus
Use of TFF3 (Trefoil factor 3) in the diagnosis
and detection of Barrett's Oesophagus using
non-invasive, non-endoscopic methods (Cytosponge).
Study shows that this method produces a
high specificity (94%) and sensitivity (78%)
in diagnosis of Barrett's Oesophagus. > Patent
CytoSponge concept and preliminary work
Patent 2626499 was filed at 2006-10-20 and it
was open to public inspection
on 2007-04-26 > BEST 1 (504 participants)
Primary objectives: safety and acceptability
Result:
1. 501/ 504 participants successfully swallowed
the Cytosponge
2. For ≥1cm circumferential BE: sensitivity =
73.3%, specificity = 93.8%
3. For ≥ 2cm circumferential BE (clinically
relevant): sensitivity = 90.0%, specificity =
93.5%
Conclusion: procedure is safe; patients find it
acceptable; lab results are promising. > BEST 2 (1100 participants)
Primary objectives: accuracy
Result:
1. 93.3% participants successfully swallowed
Cytosponge; cytosponge was favoured over
endoscopy
2. Sensitivity = 79.9% (overall); 87.2% (patients
with ≥3 cm of circumferential BE); 89.7%
(patients who swallowed Cytosponge twice)
3. Specificity = 92.4%
Conclusion: Cytosponge-TFF3 is safe and
acceptable; simple and inexpensive. > Health Economics analyses 1
Results:
1. Compared with endoscopy, cytosponge +
treatment is cheaper per participant with
higher mean gains of QALYs and lower
incremental cost-effectiveness ratio per
QALY
2. Compared with endoscopy (17%), cytosponge
reduces more incidence (19%) of
oesophageal adenocarcinoma.
Conclusion:
Cytosponge is cost effective and would reduce
cancer-related mortality compared with no
screening > Health Economic analysis 2
Conclusion: screening gastroesophageal
reflux patients with Cytosponge and
confirmation by endoscopy is an
cost-effective strategy. > BEST 3 (13,222 participants)
Primary objectives: diagnosis rate per 1000 person-years
Results:
1. Cytosponge + endoscopy diagnosed
140/6434 BE cases while endoscopy alone
diagnosed 13/6388 BE cases. The rate ratio
adjusted for cluster randomisation is 10.6.
2. 221/1654 participants tested positive for
TFF3 after Cytosponge test, they underwent
endoscopy. 131/221 of them were diagnosed
with BE or cancer.
Conclusion: Cytosponge detect 10x BE cases
than the usual GP route > Patent
Methods for detecting of
benign conditions
This patent discloses kits
and methods aiding the
diagnosis of BE using
Cytosponge. > Patent
Provides improvement on current
cell sampling device (cytosponge) for cells
lining the oesophagus. > Patent
Prognosis of Oesophageal
and Gastro-oesophageal
Junctional cancer > Patent
Methods to predict progression
of Barrett's Oesophagus to
High grade dysplasia oesophagus
adenocarcinoma > Commercialisation
Covidien purchased licence to
Cytosponge
On 2014 June 15, Medtronic bought
Covidien, now Medtronic makes the
cytosponge devices > Commercialisation
Cyted was found by Rebecca Fitzgerald
as a spin-out company to provide
centralised laboratory testing for cytosponge
and digital pathology technology
(AI and software tools) to improve diagnostic
accuracy and scale up sample evaluation
to NHS-needed level. > Health Economic analysis 3
Per patient, 1 round Cytosponge test +
endoscopy + treatment costed £82
more than usual care.
For patients who will not develop BE,
we gained:
1. additional 0.015 QALY
2. ICER of £5500 per QALY gained
For patients who have BE dysplasia/
cancer, the cost-effective was over 90%
at a willingness-to-pay threshold of
£20000 per QALY.
Conclusion: Cytosponge is cost-effective,
this will increase with more patients
accepting this test. > Health Economic analysis 4
Full adoption of Cytosponge test in NHS
Scotland will result in non-cash releasing
saving £2,000,000 over 5 years.
Financial case demonstrates a capacity
saving of £361,000 in year 2, rising to
£430,000 in year 5 > Feasibility study of Cytosponge for post
chemoradiotherapy surveillance
Result: safe, tolerable, and acceptable
for the assessment of treatment response
Funding: CRUK, NIHR, MRC Event progress
Best 4 (on going, anticipate
120,000 participants)
A Platform Trial to determine
whether Cytosponge-biomarker
technology reduces mortality from
oesophageal cancer
Primary objective: whether
Cytosponge-TFF3 test can be
used to reduce the number of
deaths due to oesophagus
cancer (OAC)
Funding: jointly funded by NIHR
HTA and CRUK
(total funding of £6.4 million) Project Delta ∆
Primary objectives: redesign the clinical
pathway for gastro-oesophageal reflux
Project summary:
1. Develop algorithms to identify individuals
most at risk
2. Offer people at risk Cytosponge-TFF3 test
3. Develop an AI algorithm to assist pathologists
with rapid diagnosis.
4. Monitor patients diagnosed with BE
regularly for early signs of cancer. High-risk
patients will be referred to endoscopy
Funding: UKRI Innovate UK and Cancer
Research UK.
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