Clinical Trials solutions 

Clinical Testing

Characterise patients in clinical trials with one single lab with two distinct technologies

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Exclusive Molecular Tools Making the Difference

Among other standard clinical testing tools, OncoDNA has developed two exclusive solutions to improve the characterization clinical trial’s patients and to ease treatment monitoring. These approaches are of course of interest in planned or up-and-running trials but also to have a comprehensive restrospectively analysis of patients’ samples collected during the trial.

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Planned or up-and-running trials or a comprehensive retrospectively analysis of patients' samples

 

  • Offering NGS and molecular pahtology as stand-alone or integrated assay

  • ISO 15189 Lab processing

  • NGS sequencing - Ion torrent or Illumina based

  • Protein expresison analysis through IHC / RNA-Seq

  • Pathologists team

  • Unique assesmement of tumour microenvironment using immunogram and upgraded immunogram to support immonotherapy clinical trials

  • Liquid or solid biopsy

We have developed solutions especially designed for your clinical testings!

We use a combination of the most relevant molecular technologies and  bioinformatic approaches to offer you molecular integrated assays.

What we do with Next-Generation Sequencing ?

OncoDNA uses Next-Generation Sequencing (NGS) to test cancer biospecimens for DNA and RNA assessment. Sequencing DNA allows us to question 3 classes of genomic alterations known to be relevant in solid tumors:

  • Somatic point mutations

  • Indels (insertions or deletions of bases)

  • Copy number variations (CNVs)

The 4th class of genomic alterations, translocations/gene fusions/rearrangements, is tested through RNA sequencing. RNA sequencing can also be used to perform expression profiling analyses.

 

What technology do we use ?

Routinely, OncoDNA runs all 3 devices from Thermo Fisher Scientific using Ion Torrent™ sequencing technology: Ion PGM, Ion Proton and Ion S5 XL Systems.

For specific projects, we can also run Illumina devices.

  • From single gene to complete panel

  • On demand target with validated panels or customized panel design

  • Using solid tumor (FFPE block or slides) and/or liquid biopsy (blood, urine, CSF, saliva, …)

  • From sample to biological and clinical interpretation

  • AND the most flexible and personalized ctDNA solution

Download genes panel

 

Off-the-shelf Immuno- histochemistry assays

OncoDNA embraces the challenges and benefits of IHC. Our molecular pathology experts come from extensive clinical pathology and research-based backgrounds.

So the IHC assays available in our portfolio can serve cancer diagnostic and cancer theranostic, question the potential benefit of different treatment approaches (Chemo, targeted therapy, immunotherapy).

  • Cancer diagnostic : ER, PR, CD117, CD10, CKs, …

  • Chemo potential benefit : TLE3, TOPO1, RRM1, TUBB3, TOP2A, …

  • Targeted therapies benefit : EGFR, VEGFR2, HER2, PTEN, …

  • Immuno therapies benefit : PD-L1, CD8, …

Immunohistochemistry assays are also great tools to question activation of some cancer pathways in cancer cells: mTOR pathway, MAPK pathway, cell cycle pathway, … we have validated IHC and pIHC assays to question those pathways

  • Cancer pathways : p4EBP1, pERK1/2, cMET, pAKT, pRB, CDK4, …

 

On-demand Immuno- histochemistry assays

Beside the large portfolio of off-the-shelf IHCs assays, OncoDNA has developed a large expertise in IHC based biomarker assay development and validation services. Developed assays can be used from preclinical development through proof of concept to testing in clinical trials, ensuring transition of procedures and technology during the drug development process.

Download IHC panel

 

 

Specific biomarkers need specific assays

Biology is complex, so is the biomarker landscape. Beside molecular alterations that can easily be tested using NGS and/or IHS, a lot of biomarkers require specific technologies/assays to be evaluated. Being technology agnostic / biomarker believer, we have put in place and validated diffrent assays to answer those specific biomarkers

Splice variants: In cancer cells, various splicing alterations have been identified that e.g. eliminate protein domains or enzymatic activities required for efficacy of cancer therapies.

OncoDNA proposes RT-QPCR based assays to test those splice variants amongst which EGFR-VIII, AR-V7, MET Exon 14 Skipping …

Methylation analysis: In glioblastoma, promoter methylation of the gene encoding for MGMT is undoubtedly the genetic fingerprint with highest impact on clinical practice. We offer this biomarker testing through a combination of bisulfite treatment and pyrosequencing for accurate and cost-efficient assessment.

FISH or CISH: While FISH cannot be utilized as a screening test for chromosomal aberrations, FISH has been widely used to identify specific molecular targets with predictive, diagnostic and/or prognostic significance. As an example, HER2 FISH PharmDx Kit still is a companion diagnostic for some HER2 inhibitors.

PCR – QPCR – dPCR: OncoDNA has developed a large selection of validated PCR based methods and assays and PCR platforms to support your development and clinical needs.

A question about other assays?

A unique immunogram to properly predict response to immunotherapy

Our immunogram combines five different biomarkers for predicting clinical benefit of immune checkpoint inhibitors (ICIs): PD-L1 protein expression (FDA-approved marker), TMB, CD8+ T-cell infiltration, MSI (FDA-approved marker) and gene alterations leading to sensibility or resistance to ICIs. 

Personalised ctDNA Assay

Liquid Biopsy to monitor treatment response

OncoDNA has developed a solution to monitor treatment response using a simple blood sample. It is the perfect tool to help pharma and biotech companies transition from tissue to blood based assays during drug development and/or for market positioning of already approved molecules.

This test is based on free circulating tumor DNA (ctDNA) in liquid biopsies, principally blood, while other matrixes are currently under validation (urine, saliva, vaginal swab, …).

 
In clinical trials, our personalized ctDNA assay can be used:

  • To identify disease recurrence and potentially identify relapse drivers by monitoring the amount of ctDNA of treated patients and identifying escaping variants., allowing this way to change/initiate treatment earlier.

  • To assess therapy response in the neoadjuvant setting to assess personalized therapies.

  • To better characterize patients and optimize their selection or randomization for clinical trials.

 

Customization for each patient can be made by selecting a set of patient-specific variants, identified in the tumor by a previous genetic test (like our OncoSTRAT&GO solution or tests like FoundationOne® or FoundationACT® from Foundation Medicine, CGP+ from Caris Molecular Intelligence or Guardant360 from Guardant Health).

 

Our assay can then be composed of one or two sets of markers:

  • A first set of markers consisting in a core panel addressing variants (SNV, Indel and CNV) or translocation. We have standard panels ranging from 10 to 40 genes but this core panel can be designed according to your genes of interest.

  • The second set of biomarkers consists in patients’ specific variants which allow to monitor the heterogeneity of the response.

Your benefits with personalised ctDNA Assay?

They already put their trust in our expertise

Interested knowing why? 
Go to testimonials
M.D. Ph.D Antonio Gualberto
Head of Development and Chief Medical Officer
Kura Oncology - USA

"Aiding physicians to identify HRAS and other mutations in HNSCC is an essential element of Kura’s clinical development strategy. Streamlining screening processes facilitates timely access to important medical information that could help oncologists and their patients in making treatment decisions"

Dr. Alan L. HO
Oncologist
Memorial Sloan Kettering Cancer Center - USA

The study met its predefined success criteria and has been amended to continue enrolling HRAS mutant HNSCC pts, as well as pts with SCC, other than HNSCC, with HRAS mutations into a new Cohort 3. (ESMO 22 october 2018)