Biomarkers can make quantifiable differences in disease outcomes. Researching use of biomarker testing in real world settings generates evidence for precision medicine implementation in oncology and other therapeutic areas.

A growing body of evidences demonstrates that positive MRD-testing at various time-points throughout the treatment course identifies patients at high risk of relapse. Therefore, it can serve as a biomarker to drive personalized therapy of certain malignancies.

The role that ecDNA plays in tumor heterogeneity, drug response and resistance is now being understood and targeted to provide a new class of treatments. Boundless Bio has developed a precision medicine platform that integrates target discovery, drug development and patient selection to accelerate the process of getting life saving therapy to patients.

The human interactome is a map of cellular components and their physical interactions. When combined with molecular patient data and AI-based methods, the human interactome can identify novel targets and pathways in autoimmune diseases. These novel targets have the potential to treat specific groups of patients, including those not responding to current therapies. Scipher and Galapagos are partnering to validate a suite of novel targets for inflammatory bowel disease.

As precision medicine expands into new areas with more complex tools, novel commercial planning techniques such as CDx patient leakage mapping become more important. In order to implement the resulting strategies, a deep understanding of each customer's PM adoption fingerprint is critical. This talk will review how a novel PM adoption framework can be leveraged to efficiently yet comprehensively understand how best to engage at the institution level. 

This will be a talk focusing on common oversights included in targeted therapy clinical validation programs that are likely to cause increased costs and submission delays.  Recommended strategies for avoiding these common mistakes will be suggested helping to ensure that the CDx is appropriate co-developed with the therapeutic compound.

This presentation will discuss the impacts of IVDR to co-development programs with respect to both commercialization/CE-marking and performance evaluation studies for companion diagnostics. Additional areas will include implications for single site lab tests (LDTs), strategies for how pharma and Dx manufacturers and how the national regulations of member states should be considered in light of IVDR. 

Biomarkers have been key in the development of pembrolizumab, including PD-L1 immunohistochemistry for specific indications and microsatellite-instability and tumor mutational burden in tumor-agnostic settings. As we approach a new era for immuno-oncology, biomarkers may take on very different role and will require new approaches to deliver insights into novel therapies and the dynamics within the tumor and its microenvironment.

A defective DNA damage repair mechanism is often associated with cancer. NGS has enabled us to further explore HRD. QIAGEN has developed the QIAseq HRD panel that provides full exonic coverage of HRR genes, including BRCA1/2 germline, somatic mutations, and genomewide coverage of targeted heterozygous SNPs to detect HRD. The panel has demonstrated high concordance to whole genome sequencing data from various cell lines and pre-characterized samples with Myriad MyChoice CDx HRD scores.

Point of care testing’s immediate results can be transformational in how we treat and diagnose conditions. However, historical challenges in implementation as well as performance have kept POCT from reaching its full impact. But with recent advancements in testing technology as well as shifting demand and expectations around testing, in part due to COVID-19, that’s changing. In this talk Dr. Brian DuChateau will review the advancements in testing technology, how this addresses past pain points, and what this symbolizes for the future of healthcare.