When?

13 September 2023
14:00 - 15:00

Where?

Online
Link will be provided by mail

Registration

Register here

Who?

Anyone interested in the topic from the DCCC ctDNA Research Center. 

National Infrastructure 2 (NI2) has worked on a reference material for the standardization of ctDNA analyses – and it has reached its final design and is ready for use after the summer of 2023!

The next step is to do a quality assurance trial (QA trial), where the laboratories analyze the samples by using their normal workflow for detection of DNA from liquid biopsies (ddPCR or NGS based methods) – and in collaboration with the involved laboratories, the results will anonymously be included in a scientific article.

For this, NI2 is looking for interested laboratories.

Everyone is invited to an online meeting on 13 September from 2-3 p.m., where the design of the QA trial will be presented, and the final design will be determined in collaboration. If you cannot participate in the meeting but are interested in participating in the QA, contact Anne Lærke Lorentzen (anne.lorentzen@clin.au.dk).

We hope that many of relevant laboratories will be a part of the QA, so we can work together on this highly important work to standardize ctDNA analyses national and work towards the goal of translating ctDNA results into clinical practice.

***Read more about the reference material and QA trial here***

Reference material:

As a short summary, the reference material includes relevant mutations from human cancers and frequent used medicaments. Further, the material spans over a wide noise profile and different types of mutations.

The reference material is designed to include variants which is frequently analyzed by ctDNA laboratories in Denmark and can be analyzed by using common methods like ddPCR and NGS. The final reference material is to be used as a quality assurance for ctDNA analyses among laboratories in Denmark as a way to obtain common standard across laboratories and facilities.

The goal is to make the reference material free and available for everyone at the Danish laboratories.

Quality Assurance Trial (QA):

This is why NI2 will make a quality assurance trial of ctDNA analyses across laboratories, who as a routine analyze low frequent DNA measures in liquid biopsies with ddPCR and NGS based methods (including ctDNA analyses in plasma).

Here is more information about the QA:

• Purpose:
  Quality assurance of ctDNA analyses among Danish laboratories to identify the best laboratory workflow for ctDNA detection.

• Why:
  National standardization of ctDNA analyses is necessary to act upon the promising clinical applications that ctDNA offers and translate ctDNA results into clinical practice. Quality assurance of ctDNA analyses will involve a certification program with the aim of accrediting ctDNA laboratories by national standards.

• Who:
  All laboratories in Denmark with interested in achieving a common standard for low-frequent liquid biopsy analyses, including ctDNA measurements in plasma. Laboratories that routinely analyze low frequent DNA measurements using ddPCR or NGS-based methods, are covered by the reference material from the ctDNA Center.

• How:
  The ctDNA Center will send out a set of reference samples to interested laboratories, who will analyze the samples using their common laboratory workflow for DNA detection from liquid biopsies (ddPCR or NGS-based methods). In collaboration with the involved laboratories, results will anonymously be included in a scientific article that analytically evaluates the performed analyses. 

• Expectation:
  The ctDNA Center covers the expenses in connection with the creation and distribution of reference samples. Since the reference samples are designed to be included in common laboratory workflows, the costs in relation to the analyses performed will be charged to each party. The various parties will participate in the dissemination of the results from the quality assurance trial in a scientific article.

If you have any questions about the reference material, please contact Mads Heilskov Rasmussen (leader of NI2) at mads.heilskov@clin.au.dk.

ADDRESS FOR THE SECRETARIAT

Science Center Skejby, MOMA
Brendstrupgårdsvej 21, build. A
8200 Aarhus N

CONTACT

ctDNA@clin.au.dk
+45 78 45 53 39