Companion Diagnostic Development

From biomarkers to standardized assays

Partnering with Biopharmaceutical Companies

Cancer immunotherapy has a bright future in cancer provided one can predict which patients respond and how to monitor changes in response.
Leveraging its expertise and know-how in diagnostic, HalioDx team has strong track record in the development, registration and commercialization of cancer IVD’s for the European, US and Japanese markets.

HalioDx offers to its partners strong expertise and quality controlled capabilities to develop successfully companion diagnostics products for a co-registration to the FDA.

HalioDx offers a range of technology platforms from Immunohistochemistry utilizing robust multiplexed protocols to molecular approaches (qPCR, nCounter, NGS) to investigate candidate companion biomarkers.

Our discovery approach, leveraging advanced image analysis and validated bioinformatics pipelines, has produced a number of diagnostic applications in the immuno-oncology field.  Our bio-statistic expertise in supervised, unsupervised and deep learning approaches, associating curated clinical data, is instrumental for the success of discovery projects.

At HalioDx we have a significant track record in developing IVD systems associating reagents and software for cancer diagnostic for our own pipeline or for partners. Our unique organization allows flexibility, speed and accountability to match partner needs.

We integrate in our project core teams all essentials requirements to successfully deliver companion diagnostic:

  • Involvement of our IVD experts at inception and all along the project to make sure that all prerequisites are covered and then monitored and aligned with our partner objectives.
  • Involvement from the very beginning of the project of our commercial, regulatory and operations (QA/manufacturing) teams to ensure market readiness and seamless transition to commercial stage.
  • A mature and efficient Design Control process ISO 13485 & ISO 9001 certified and in compliance with 21 CFR part 820 de-risking projects while allowing maintaining timelines.
  • A milestone based structure enabling transparent projects monitoring by joint steering committee during the development.

Regulatory project planning is among the most important part of a CDx development and HalioDx has gained a significant experience in successful large international IVD registration projects.

Clinical testing: Our regulatory team manages large clinical trials projects either at third party clinical sites (Institutions, CRO’s) or internally in compliance with Good Clinical Laboratory Practices (GCLP).

HalioDx has a specific know-how and experience in manufacturing IVD’s according to cGMP’s supported by an effective quality system inspected by several authorities. Our very unique organization allows both a rigorous COGS control and scalability to fulfill the needs of our partners.

HalioDx understands that a critical measure of a companion diagnostic project is the business impact for our partners. To this end we propose our CDx partners to engage our Medical Affairs and Marketing teams on product positioning, market readiness and reimbursement/market access.

HalioDx team has a significant track record in successfully introducing new /innovative IVD’s in US, EU and many other countries via its own sales force or in combination with its distributor network.