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Precision Medicine highlights from ECP 2023

20 September, 2023

The 35th European Congress of Pathology (ECP) provides a platform for the latest advancements in the field of pathology and precision medicine. This year’s congress took place on 9-13th September in Dublin, Ireland and saw a total of 4,400 participants attending from 94 countries.

Our team of precision medicine experts share their key highlights from the sessions attended:

Trastuzumab deruxtucan (T-DXd) is now approved for HER2-Low

  • Trastuzumab deruxtucan has been previously approved (2019) for HER2 positive as a result of the DESTINY-01 trial.
  • T-DXd is now approved (2023) for HER2-Low from the DESTINY-04 trial – population HER2-Low metastatic breast cancer (mBC), pre-treated with chemotherapy.
  • Existing assays and scoring exhibit inconsistencies for HER2-Low but are recommended for use with training on the full spectrum of low HER2 expression.
  • Ongoing trials are expected to elucidate the lower threshold of HER2 with existing assays needed for treatment with T-DXd and its mechanism of action.
  • Newer quantitative technologies may be more accurate for the quantification of low expression and their predictive value will have to be determined.


Predictions that specific pathology Al applications will be routinely used by 2030

  • Industry professionals remain almost certain that specific pathology Al applications will be routinely used by 2030.
  • There is a strong consensus that Al will improve KPI & diagnostic accuracy, and that the number of computational pathology specialists is going to greatly increase.
  • A positive impact on the pathologist workforce was predicted, although reservation remains regarding whether Al will truly lead to increased efficiency.
  • It is very likely that Al will see routine use for specific pre-, post-, and analytical tasks, and that many of these tasks are going to be fully delegated to Al (colorectal polyps & cervical cytology screening, case assignment etc.).
  • Many applications are projected to be routinely used by 2030 to address basic tasks currently performed by pathologists rather than "aspirational" tasks, such as prediction of molecular biomarker status or clinical outcomes directly from histology.

NGS for the detection of microsatellite instability (MSI) in colorectal cancer (CRC) with deficient DNA mismatch repair

  • NGS is performant in the diagnosis of MSI, but a rigorously validated algorithm is needed when compared to other gold standards.
  • MSI care is a performant in CRC and is moving quickly to demonstrate its high performance in other cancer areas, with gastric and endometrial cancers being a specific focus.
  • ´╗┐NGS can predict patient response to immunotherapy with immune checkpoint inhibitors (ICI) in metastatic colorectal cancer (mCRC) patients using both RNA and DNA sequencing. This should be of interest for improving personalized care of MS cancer patients.
  • Tumor mutation burden (TMB) is unlikely to constitute a robust predictive index for response to ICI in mCRC patients with confirmed MSI CRC. Tumors with misdiagnosed dMMR/MSI status are pitfalls for the correct estimation of this genomic index.

ESMO recommendations for liquid biopsy testing and the use of liquid biopsy to monitor the response to therapy

  • Circulating tumor DNA (ctDNA) testing is currently recommended only for genomic profiling in patients with advanced cancer when tissue is not available or faster results are needed. Early cancer diagnosis is therefore an important future application of ctDNA testing.
  • Interventional trials are ongoing in early cancer patients to develop novel therapeutic strategies based on minimal residual disease (MRD) detection by ctDNA testing.
  • In patients with advanced disease, ctDNA testing can provide information that is complementary to tissue testing on tumor heterogeneity and that can aid to personalize treatments.
  • The dynamic of ctDNA is as an early marker of response/resistance to therapy, and one which might provide relevant information for personalization of treatments.

 

Liquid biopsy (LBx) in immuno-oncology

  • The existing aim is to benchmark available ctDNA assays for sensitivity, specificity, and predictive value in the adjuvant setting, where MRD is indicative of disease progression.
  • This includes clinically validating the top ranking ctDNA assays prospectively in patients diagnosed with NSCLC, CRC and PDAC and producing a patient-centric roadmap for the clinical implementation of ctDNA diagnostics.
  • Liquid biopsy analyses of circulating tumor cells (CTCs), ctDNA and extracellular vesicles require ultrasensitive assays.
  • Key clinical practice gaps of LBx have been identified as tissue, testing, turnaround time, and cost.
  • Preanalytical considerations for LBx include; blood collections, plasma preparation, cell free DNA (cfDNA) isolation and storage.
  • Combined CTC and immune cell analyses may provide comprehensive information on tumor development and progression.
  • Resistance to immunotherapy may depend on both tumor and patient response.
  • Interaction between CTCs/DTCs (disseminated tumor cells) and immune cells needs to be studied.

  

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About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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Caroline Forde
Robyn Fisher
 
Kieran Breheny