Pharma partnering | Biocartis

The Idylla System

For fully automated, sample to result, and scalable testing across all lab settings

A dedicated CDx co-development team

Expertise in all aspects from R&D to commercialization

A global presence

~2,000 Idylla placements in > 75 countries providing nearly real-time test results for your therapies

Our pharma partners

Read about Biocartis’ current pharma partnerships

Democratizing rapid patient access to precision medicine

At Biocartis, our mission is to ensure patients and their physicians have access to the right test results at the right time to deliver the right treatment

Today's precision medicine requires batch-based biomarker testing, with result reporting often taking several weeks.1 As a consequence, nearly 80% of cancer patients in the USA lack genetic mutation results at the initial oncology consultation and up to 25% of patients begin treatment before receiving their results.2 For patients, a delay in receiving molecular diagnostic results means a delayed start of optimal treatment or – even worse – a sub-optimal treatment decision. In some cases, patients have already deceased before the biomarker test result is available.3 For you, as a pharmaceutical company, this means delays or missed opportunities to enroll patients into your clinical trials and later for clinicians to prescribe your approved therapies as often only tested patients are eligible. Idylla™ is the solution to this problem!

1• Schwaederle et al. (2014) Oncologist 19, 631 – 636 • Saunders et al. ESMO 2016, Abstract #526P • INCa 2012 Survey • Etude FLASH RAS 2014 • Scott et al. (2014) Asia Pac J Clin Oncol. 10(3):261-5
2Mellert H et al. (2017) J Mol Pathol. 19(3): 404–416
3Finall et al. Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up. J Clin Pathol. 2022 Jan 18

Meet Idylla

Idylla™ enables easy and local access to rapid molecular diagnostics information to physicians and patients worldwide.

With two minutes of hands-on time, results within two to three hours and random access (no need for batching), our revolutionary, fully automated platform makes molecular testing convenient, affordable and exceptionally fast; facilitating decentralized molecular testing to accelerate patient access to precision medicine.

Idylla Platform Idylla Assays Idylla Global Presence

Why partner with Biocartis for a companion diagnostics?

A dedicated CDx co-development team

We at Biocartis work closely together with our pharma partners to facilitate accelerated access to treatment by ensuring companion diagnostic (CDx) testing readiness in the relevant markets at time of launch. Our dedicated CDx team includes proven, IVD-experienced project managers, highly qualified scientists, manufacturing, quality and regulatory personnel as well as a strong commercial team to support and accelerate all aspects of our co-development efforts moving from research/feasibility and IUO readiness through analytical and clinical validation phases to commercialization.

R&D experience

The Biocartis Research & Development (R&D) team comprising scientists, laboratory professionals, industrialization experts, product engineers, software specialists, data scientists and biostatisticians, has extensive experience in developing in-vitro diagnostic assays. Product development is fully integrated with our FDA- and ISO-conforming Design Control system for seamless transition from development stages to manufacturing and commercialization.

Quality and regulatory efficiency

We are continuously working on the production of safe, effective and high-quality products which comply with applicable regulations.
Our Quality Management System (QMS) is compliant with ISO 13485:2016, 21CFR820 and other international regulations to enable worldwide marketing of the Biocartis platform and associated applications.
Biocartis QMS is designed to the highest standards to support PMA filings in US.
Biocartis QMS is ISO 13485:2016 and MDSAP certified for Canada, Australia, Brazil, Japan and US by BSI.

Our regulatory team has significant experience in navigating the regulatory landscape in key global territories. The Idylla™ Platform as well as most of our assays are CE-marked and approved in numerous countries worldwide. In addition, Biocartis’ Idylla™ Instrument and Idylla™ Console are listed as class II exempt from FDA 510(k) notification with FDA-cleared or -approved assays.

Commercial expertise

Our commercial operations team engages with our partners early in the development phase to ensure that product design requirements reflect customer and market needs from an analytic performance, end-user and economic perspective. Our sales, marketing and market access teams have a deep understanding of the oncology testing landscape in the key global territories and will support the launch of the CDx in close alignment with you by:

Developing a global launch strategy for the CDx
Developing and implementing market access and reimbursement strategies
Setting up KOL programs to drive market awareness and readiness for the diagnostic test
Establishing medical education programs
Organizing trainings for lab staff

Coupling our market preparation work with our direct sales force and distributor partner network enables us to leverage our existing key relationships with molecular diagnostic (MDx) end users, physicians and purchasers in over 75+ countries.

Research collaborations

With our proprietary Idylla™ Platform we have successfully validated several fully automated sample-to-result, real-time PCR Tests in cancer and infectious diseases, that can use whole blood, plasma, or tissue samples for the detection of DNA and mRNA targets. The Platform also seamlessly integrates bio-IT algorithms for target calling and score calculations with the instrumentation.
Today our R&D activities not only focus on key additions to our test menu based on the validated technology, but we also strive to improve our technology toolbox and the range of biomarkers that can be deployed in Idylla™. To this end, we have a profound interest in research collaborations, which can be in the form of industry partnerships, joint grant applications and industry advisory committee roles in academic grants. Our views and vision are nurtured by customer experience, KOL interactions, and Scientific Advisory Board discussions.
Our interest particularly lies in solutions that can extend the scope of the Idylla™ Platform and menu including:

Biomarkers such as novel driver or resistance mutations, gene expression, methylation, or miRNA signatures, that are predictive or prognostic in cancer, infectious diseases, neurological or immune disorders, and genetic diseases (see also Partnering section).
Biomarkers and solutions that can be deployed with our newly developed patient-specific molecular surveillance and generic cartridge technologies.
Large plasma, urine or blood volume solutions that can be integrated/connected with Idylla™’s liquid biopsy solutions, and which allow ultrasensitive detection of circulating DNA, RNA, or other nucleic acids.
Pre- and post-analytical solutions that connect to Idylla™ testing and can e.g., digitally annotate cancer samples or allow refined use of algorithms and novel result reporting approaches.

Biocartis’ proprietary platform and test solutions are built on a large number of patents and patent applications, know-how, and trademarks. We are open to discuss in- and out-licensing opportunities, including the intellectual property related to the above topics ([email protected]).
With the existing Idylla™ Tests, the use of sample types, indications, and uses that have not been validated before can be explored. Please visit our investigator-initiated study program (link) to propose innovative and unexplored ideas for such use in a research study.