CA-AGENDIA/ILLUMINA
10.1.2022 22:21:14 CET | Business Wire | Press release
Agendia, Inc. , a commercial stage company focused on precision oncology for breast cancer, today announced a multi-year partnership with Illumina, Inc. (NASDAQ: ILMN), to co-develop in vitro diagnostic (IVD) tests for oncology testing. The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina’s approach to IVD partnerships in oncology. Agendia joins Illumina’s growing portfolio of more than 30 IVD partners developing over 40 sequencing-based solutions for cancer prognosis, therapy selection, and other applications.
Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeq™Dx sequencing platform to expand the range of gene panels available for solid tumor analysis. The company expects its flagship test, MammaPrint®, which is FDA-cleared and currently offered via Agendia’s central laboratory, will be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA.
“This partnership represents a major step in Agendia’s integration of NGS technologies and brings us even closer to our promise of providing crucial genomic information to physicians and their patients to guide care at every single step in a patient’s treatment journey,” said Mark Straley, Chief Executive Officer of Agendia. “We believe our current FDA-cleared, broadly reimbursed MammaPrint test provides the perfect foundation for incorporation with Illumina’s MiSeqDx platform. Together, we plan to expand what is possible in breast cancer care and ensure that the essential insights that come from genomic testing are delivered to patients around the world.”
Illumina’s robust diagnostic NGS product portfolio, including the MiSeq™Dx platform, covers a broad range of clinical applications designed for a variety of clinical lab settings. As NGS testing becomes more integrated in routine patient care, Illumina is committed to providing clinical solutions, through both products and partnerships, that enable the diagnosis and management of human diseases.
Agendia’s proprietary testing solutions empower physicians to more accurately diagnose the disease drivers and predict the progression of a woman’s breast cancer. The company’s scientific approach provides a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to personalize treatment. The company believes the decentralized MammaPrint NGS test, developed on the Illumina MiSeq™Dx platform, will enable major clinical hospitals worldwide to offer the clinical utility and benefits of MammaPrint to their physicians and patients in-house. In addition, the MammaPrint NGS test will leverage nearly two decades of clinical evidence drawn from 30 clinical studies featuring over 30,000 patients with breast cancer, as well as a 15-year history of FDA clearance, top tier medical society guideline inclusion, and well-established and unique CPT codes for broad reimbursement.
“We are pleased to partner with Agendia, with its deep expertise in genomic testing in breast cancer, to expand the reach of NGS-based genomic testing in cancer care,” said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. “We believe enabling in-house clinical testing will strengthen the knowledge of the healthcare network, reduce turnaround times, and ultimately better support more patients with improved guidance on care pathways.”
About Agendia
Agendia is a mission-driven, commercial stage company focused on enabling state-of-the-art decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.
MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.
For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20220110005960/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release
A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release
Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas
ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release
OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future
Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority
Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release
Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom