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In February 2016, Biocartis announced its collaboration with Amgen, a leading biotechnology company (NASDAQ: AMGN), to offer its new RAS biomarker tests to hospitals in Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain and Turkey. Aim of the partnership is to accelerate access to RAS biomarker information in the selected countries. In December 2016, the partnership was expanded to accelerate access to RAS biomarker information in up to 10 European countries. One year later, in December 2017, Biocartis announced the signing of its CDx development agreement with Amgen, aimed at the registration of the Idylla™ RAS biomarker tests with the US FDA as a companion diagnostic test for Amgen’s drug Vectibix® (panitumumab).

In 2021, partnership with Amgen reoriented towards the evaluation of the suitability of Biocartis technology as a potential companion diagnostics for an undisclosed research program. Due to the market need and opportunities in this area, both parties decided to discontinue their ongoing project in the colorectal cancer area aimed at PMA submission of the Idylla™ RAS tests with the US FDA and to resource the new high-priority feasibility assessment program.

Biocartis and AstraZeneca, a global science-led biopharmaceutical company (LSE/STO/Nasdaq: AZN), announced their first partnership agreement on 29 November 2018, focused on overcoming the current complexity and long turnaround time of biomarker testing for lung cancer patients. In January 2020, the collaboration expanded to a master collaboration agreement, with as first project the large prospective lung cancer FACILITATE study with the Idylla EGFR Mutation Assay (Research Use Only). The study, which was selected for presentation at the renowned ESMO Virtual Congress in September 2020 (poster 1205P), concluded that Idylla™ EGFR testing may add value in a clinical setting to generate actionable EGFR mutation results for non-small cell lung cancer (NSCLC) patients faster than routinely used methods.

On 4 May 2021, Biocartis and AstraZeneca announced a new agreement aimed at providing access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in Biocartis’ European and global distributor markets to support the identification of patients with EGFR mutations.

On June 22, 2022 , Biocartis announced a new agreement with AstraZeneca aimed at the development and US FDA premarket approval of a novel companion diagnostic (CDx) test for use with Tagrisso® (osimertinib), AstraZeneca’s third-generation EGFR-TKI (tyrosine kinase inhibitor) treatment. Under the terms of the agreement, Biocartis and AstraZeneca will co-lead the development and applicable premarket approval of the Idylla™ EGFR CDx Assay intended to aid in identifying patients with non-small cell lung cancer (NSCLC) who may respond to treatment with Tagrisso®. In addition to formalin fixed, paraffin embedded (FFPE) tissue, Biocartis will seek to validate the use of less invasive cytology samples such as fine needle aspirates for use with the Idylla™ EGFR CDx Assay, to expand patient access to testing.

BMS

On 12 March 2019, Biocartis announced the signing of a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company, aimed at the potential registration as a companion diagnostic and use of the Idylla™ MSI test in connection with immuno-oncology therapies. The collaboration agreement allows for joint developments and registrations of the Idylla™ MSI test for use in a variety of indications, commercial settings and geographies. The first focus under the agreement is expected to be the registration in the United States of the Idylla™ MSI test as a companion diagnostic test in mCRC. On 5 March 2020, Biocartis announced to have signed a new immune-oncology project with Bristol-Myers Squibb Company aimed at the registration of the Idylla™ MSI test in the People’s Republic of China. On 1 October 2020, Biocartis joined the COVID-19 Industry Testing Consortium led by BMS with the aim to improve, innovate and accelerate all aspects of testing, including research, regulatory oversight, clinical implications, reliability and access.

Covance

On 23 April 2019, Biocartis announced the global strategic commercialization agreement with Covance, LabCorp’s Drug Development business and which has the leading central laboratory network serving the biopharma industry, across multiple therapeutic areas, with a specific focus on precision medicine. The agreement aims at offering the Idylla™ platform and its existing Idylla™ oncology assay menu (research use only) to Covance’s customer base to support global oncology trials and, when appropriate, to validate and implement companion diagnostic applications.

Janssen Pharmaceutica NV (JPNV) signed a strategic partnership with Biocartis in December 2010 to co-develop assays for the IdyllaTM platform and collaborate commercially.

Kite/Gilead

On 1 June 2019, Biocartis announced that it has entered into a Master Development and Commercialization Agreement with Kite, a Gilead Company (a pharmaceutical company engaged in the development of innovative cancer cell therapies). The agreement is aimed at the development of molecular-based assays on the Idylla™ platform that are supportive to Kite’s therapies. The collaboration with Kite is Biocartis’ second assay development partnership (next to the partnership with BMS) in the immunotherapy domain, a fast growing market and one of the key strategic focus areas of the Idylla™ assay menu.

Biocartis announced a partnership with Merck KGaA (Darmstadt, Germany) in January 2016 to improve access to easy, rapid and low invasive blood-based molecular diagnostic testing for patients with mCRC through liquid biopsy testing. Under the partnership, the liquid biopsy assays Idylla™ ctKRAS Mutation Assay and the Idylla™ ctNRAS-BRAF Mutation Assay were developed.

lilly

On 10 august 2023, Biocartis announced that it has entered into a new post-commercial collaboration program with Lilly, a global pharmaceutical company. This program will explore the advantages of adding the Biocartis IdyllaTM Platform to a molecular diagnostics workflow in global clinical labs via a study in hospitals across Spain. The focus will be to understand how the Idylla™ Platform can contribute to a more expeditious and comprehensive approach to identify targetable alterations when compared to various current clinical workflows for NSCLC patients.