Genetron Health Releases New Data Results of HCCscreen™ for Liver Cancer Early Screening in China
HCCscreenTM achieved 88% sensitivity and 93% specificity, compared with 71% and 95%, respectively, by ultrasound plus AFP.
In early-stage patients, the sensitivities of HCCscreenTM are 85% (tumor size of <3cm) and 96% (3-5 cm).
The Company plans to initiate an NMPA registrational trial in
Management team will discuss the data at the upcoming
This multi-center prospective study, named the “HCCscreenTM Investigational Study” (HIT), is a collaboration between
Table 1. HIT Results: Genetron HCCscreenTM Final Analysis (N=1615)
HCCscreenTM Test |
HCC |
Non-HCC |
Total |
|||
Test - Positive |
76 |
110 |
186 |
|||
Test - Negative |
10 |
1,419 |
1,429 |
|||
Total |
86 |
1,529 |
1,615 |
|||
Sensitivity (95% CI) |
88% (80%, 94%) |
|
|
|||
Specificity (95% CI) |
|
93% (91%, 94%) |
|
Table 2. HIT Results: Ultrasound + AFP Final Analysis (N=1615)
Ultrasound + AFP |
HCC |
Non-HCC |
Total |
|||
Test - Positive |
61 |
83 |
144 |
|||
Test - Negative |
25 |
1,446 |
1471 |
|||
Total |
86 |
1,529 |
1615 |
|||
Sensitivity (95% CI) |
71% (60%, 80%) |
|
|
|||
Specificity (95% CI) |
|
95% (93%, 96%) |
|
Furthermore, stratified by tumor size, 49% (28/57) of the cases identified by HCCscreenTM were in early stage, i.e. <3cm. These patients are expected to have much better prognosis than advanced stage ones. Additionally, HCCscreenTM achieved sensitivities of 85% for tumor sizes of <3cm, 96% for 3-5cm, and 88% for >5cm. The results are summarized in the following table:
Table 3. HIT Results: Genetron HCCscreenTM Sensitivities by Tumor Size
Tumor Size (N=64) |
||||||||
HCCscreenTM Test |
<3cm |
3-5cm |
>5cm |
Total |
||||
Test Positive |
28 |
|
22 |
|
7 |
|
57 |
|
Test Negative |
5 |
|
1 |
|
1 |
|
7 |
|
Total |
33 |
|
23 |
|
8 |
|
64 |
|
Sensitivity |
85% |
|
96% |
|
88% |
|
|
Previously,
Table 4. HIT Results: Genetron HCCscreenTM Preliminary Data (N=297)
HCCscreenTM Test |
HCC |
Non-HCC |
Total |
|||
Test - Positive |
11 |
|
20 |
|
31 |
|
Test - Negative |
1 |
|
265 |
|
266 |
|
Total |
12 |
|
285 |
|
297 |
|
Sensitivity (95% CI) |
92% (62%, 100%) |
|
|
|
|
|
Specificity (95% CI) |
|
|
93% (89%, 96%) |
|
|
“We are very pleased with the new HCCscreenTM data from this large, prospective cohort study, which showed overall better sensitivity data, and comparable specificity data versus the standard of care. These additional validation updates gave us more confidence about our assay’s performance, and we will move forward to initiate an NMPA registrational study in the second quarter of this year,” said Mr. Sizhen Wang, co-founder and CEO of
About HCCscreenTM and Liver Cancer
In
Globally, liver cancer is the fourth most common cause of cancer-related death and the sixth in terms of incidence1.
HCCscreenTM is powered by Genetron Health’s innovative and proprietary Mutation CapsuleTM technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens.
References:
-
Villanueva, A. Hepatocellular Carcinoma.
N. Engl . J. Med. 2019, 380, 1450–1462. - Globocan 2018. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Information on this website is not incorporated into this update and should not be considered part of this update. We have included any website as an inactive textual reference only.
About
Safe Harbor Statement
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005932/en/
Investor Relations Contact
US:
Head of Investor Relations
Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255
Managing Director |
ir@genetronhealth.com
Media Relations Contact
yanrong.zhao@genetronhealth.com
ICR
Edmond.Lococo@icrinc.com
Mobile: +86 138-1079-1408
genetron.pr@icrinc.com
Source: