Illumina expands clinical oncology portfolio unlocking new standard of care and access to precision therapies
Illumina (NASDAQ: ILMN) announced an expansion of its clinical oncology portfolio with two key developments. First, their TruSight™ (TSO) Comprehensive test, the first FDA-approved distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, has gained broad payer reimbursement including Medicare and most commercial health plans. UofL Health became the first customer to implement the test. The test has also received regulatory approval in Japan.
Second, Illumina partnered with Pillar Biosciences to offer Pillar oncoReveal CDx, an IVD kit for detecting genetic variations in 22 genes for solid tumor patients. The test recently received nationwide Medicare coverage, making it accessible to over 66 million Medicare beneficiaries in the US.
Illumina (NASDAQ: ILMN) ha annunciato un ampliamento del suo portafoglio oncologico clinico con due sviluppi chiave. In primo luogo, il loro test TruSight™ (TSO) Comprehensive, il primo kit IVD di profilazione genomica completa approvato dalla FDA con indicazioni CDx pan-cancro, ha ottenuto un ampio rimborso da parte dei pagatori, inclusi Medicare e la maggior parte dei piani sanitari commerciali. UofL Health è diventato il primo cliente ad adottare il test. Il test ha inoltre ricevuto l'approvazione regolatoria in Giappone.
In secondo luogo, Illumina ha stretto una partnership con Pillar Biosciences per offrire Pillar oncoReveal CDx, un kit IVD per l'individuazione di variazioni genetiche in 22 geni per pazienti con tumori solidi. Il test ha recentemente ottenuto la copertura Medicare a livello nazionale, rendendolo accessibile a oltre 66 milioni di beneficiari Medicare negli Stati Uniti.
Illumina (NASDAQ: ILMN) anunció la expansión de su cartera clínica en oncología con dos desarrollos clave. Primero, su test TruSight™ (TSO) Comprehensive, el primer kit IVD de perfilado genómico integral aprobado por la FDA con indicaciones CDx para cánceres múltiples, ha obtenido un amplio reembolso de pagadores, incluyendo Medicare y la mayoría de los planes de salud comerciales. UofL Health fue el primer cliente en implementar el test. El test también recibió aprobación regulatoria en Japón.
En segundo lugar, Illumina se asoció con Pillar Biosciences para ofrecer Pillar oncoReveal CDx, un kit IVD para detectar variaciones genéticas en 22 genes para pacientes con tumores sólidos. El test recibió recientemente cobertura nacional de Medicare, haciéndolo accesible para más de 66 millones de beneficiarios de Medicare en EE. UU.
Illumina (NASDAQ: ILMN)는 임상 종양학 포트폴리오를 두 가지 주요 개발로 확장했다고 발표했습니다. 첫째, FDA 승인을 받은 최초의 배포 가능한 종합 유전체 프로파일링 IVD 키트인 TruSight™ (TSO) Comprehensive 테스트가 메디케어 및 대부분의 상업 건강 보험을 포함한 광범위한 보험 급여를 받았습니다. UofL Health가 이 테스트를 최초로 도입한 고객이 되었습니다. 이 테스트는 일본에서도 규제 승인을 받았습니다.
둘째, Illumina는 Pillar Biosciences와 협력하여 고형 종양 환자의 22개 유전자 변이를 탐지하는 IVD 키트인 Pillar oncoReveal CDx를 제공하게 되었습니다. 이 테스트는 최근 미국 내 6600만 명 이상의 메디케어 수혜자가 이용할 수 있도록 전국적인 메디케어 보험 적용을 받았습니다.
Illumina (NASDAQ : ILMN) a annoncé l'élargissement de son portefeuille clinique en oncologie avec deux développements majeurs. Premièrement, leur test TruSight™ (TSO) Comprehensive, le premier kit IVD de profilage génomique complet approuvé par la FDA avec des indications CDx pan-cancer, a obtenu un remboursement étendu incluant Medicare et la plupart des régimes de santé commerciaux. UofL Health est devenu le premier client à mettre en œuvre ce test. Le test a également reçu une approbation réglementaire au Japon.
Deuxièmement, Illumina s'est associée à Pillar Biosciences pour proposer Pillar oncoReveal CDx, un kit IVD destiné à détecter les variations génétiques sur 22 gènes chez les patients atteints de tumeurs solides. Ce test a récemment obtenu une couverture Medicare à l'échelle nationale, le rendant accessible à plus de 66 millions de bénéficiaires Medicare aux États-Unis.
Illumina (NASDAQ: ILMN) gab eine Erweiterung seines klinischen Onkologie-Portfolios mit zwei wichtigen Entwicklungen bekannt. Erstens hat ihr TruSight™ (TSO) Comprehensive Test, das erste von der FDA zugelassene, verteilbare umfassende genomische Profiling-IVD-Kit mit pan-krebs CDx-Zulassungen, eine breite Kostenerstattung einschließlich Medicare und den meisten kommerziellen Krankenversicherungen erhalten. UofL Health wurde der erste Kunde, der den Test implementierte. Der Test erhielt zudem eine behördliche Zulassung in Japan.
Zweitens ging Illumina eine Partnerschaft mit Pillar Biosciences ein, um Pillar oncoReveal CDx anzubieten, ein IVD-Kit zur Erkennung genetischer Variationen in 22 Genen bei Patienten mit soliden Tumoren. Der Test erhielt kürzlich eine landesweite Medicare-Abdeckung und ist damit für über 66 Millionen Medicare-Berechtigte in den USA zugänglich.
- TSO Comprehensive test gained broad payer reimbursement coverage including Medicare and commercial health plans
- TSO Comprehensive received regulatory approval in Japan, expanding international market reach
- New partnership with Pillar Biosciences adds oncoReveal CDx to portfolio, expanding diagnostic offerings
- oncoReveal CDx received nationwide Medicare coverage, accessing 66+ million potential patients
- None.
Insights
Illumina's expanded reimbursement and new diagnostic partnerships strengthen its precision oncology position, boosting revenue potential and market reach.
The expanded reimbursement coverage for Illumina's TSO Comprehensive test represents a significant commercial milestone. Securing both Medicare and commercial payer coverage removes the primary adoption barrier for genomic profiling tests. Historically, lack of reimbursement has severely limited clinical implementation of comprehensive genomic profiling despite its clinical utility.
The test's dual RNA/DNA capabilities provide a competitive advantage over single-analyte tests, enabling detection of both mutations and fusion events critical for targeted therapy selection. This comprehensive approach aligns with the evolving standard of care in precision oncology where multiple biomarkers must be assessed simultaneously.
The distributed testing model that allows hospitals to perform testing in-house addresses a key market need. This approach significantly reduces turnaround time compared to send-out testing models, potentially improving patient outcomes by accelerating treatment decisions. The adoption by UofL Health signals market acceptance from academic medical centers – typically early adopters whose practices influence community settings.
The regulatory approval in Japan provides entry into a substantial oncology market with approximately 1 million new cancer diagnoses annually. Japan represents a sophisticated healthcare market with growing precision medicine adoption.
The partnership with Pillar Biosciences to offer oncoReveal CDx creates a complementary testing strategy that broadens Illumina's market coverage. While TSO Comprehensive offers extensive biomarker analysis, the 22-gene oncoReveal panel likely provides a more focused, potentially lower-cost option for specific clinical scenarios. The Medicare coverage for oncoReveal enhances its commercial viability.
These developments collectively strengthen Illumina's competitive position against other precision oncology players like Exact Sciences, Foundation Medicine, and Thermo Fisher. The expanded portfolio and improved reimbursement landscape should drive increased testing volumes and contribute positively to Illumina's clinical revenue segment.
Following FDA approval last year, Illumina's TSO Comprehensive test gains broad payer reimbursement, expanding access to comprehensive genomic profiling to match patients with targeted therapies
Illumina's IVD portfolio will also expand to offer Pillar oncoReveal® CDx, the newest panel to deliver critical companion diagnostic testing using the Illumina MiSeq™ Dx System
"Access to tumor profiling is essential to deliver on the promise of precision cancer care," said Everett Cunningham, chief commercial officer of Illumina. "With our growing portfolio of distributable clinical solutions, we are unlocking the next new standard of care for clinicians and their patients. With TSO Comprehensive and Pillar oncoReveal CDx, more labs can perform tumor profiling in-house, allowing oncologists to rapidly understand the genomic drivers of disease, and match their patients to the best possible therapies."
Illumina TruSight™ (TSO) Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. This enables clinicians to rapidly match cancer patients with targeted therapies using comprehensive tumor profiling. Illumina customers across the US -- in community oncology care practices, regional hospitals and health systems, and academic medical centers -- are integrating TSO Comprehensive into their clinical practice. This month, UofL Health – UofL Hospital became the first Illumina customer to begin offering the test to patients.
"We are excited to bring TSO Comprehensive to our patient and provider community. Access to an in-house comprehensive tumor profiling solution will allow our care teams to deliver faster precision therapy decisions for our patients," said Mustafa Al-Kawaaz, MD, assistant professor and director of Hematology, Cytogenetics and Molecular Pathology in the Department of Pathology and Laboratory Medicine at the University of Louisville School of Medicine.
TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS), as well as most commercial health plans.
Illumina continues to pursue expanded biomarker indications and CDx claims for TSO Comprehensive in the US. Also announced today, the IVD kit has now received regulatory approval in
Illumina expands partnership with Pillar Biosciences to boost access to clinical diagnostics
Expanding its IVD portfolio, Illumina is partnering with Pillar Biosciences to offer Pillar oncoReveal CDx to Illumina customers beginning this summer. The oncoReveal CDx IVD kit is used for the detection of genetic variations in 22 genes and is intended for previously diagnosed patients with solid tumors. In April, Pillar announced that oncoReveal CDx received nationwide Medicare coverage by the CMS.
'With over 66 million people in the US covered by Medicare, reimbursement of oncoReveal CDx will help ensure that highly accurate, actionable, and reimbursable next-generation sequencing testing is available to clinical laboratories and biopharmaceutical companies," said Brian Wright, chief marketing officer of Pillar Biosciences. "In turn, this enables faster treatment decisions and improved outcomes for everyone, everywhere."
Learn more about Illumina at ASCO and visit us at Booth 33101.
About TruSight Oncology Comprehensive
TSO Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. Comprehensive genomic profiling is a next-generation sequencing approach that uses a single assay to assess hundreds of genes—including relevant cancer biomarkers, as established in guidelines and clinical trials—for therapy guidance. TSO Comprehensive interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood that an immuno-oncology biomarker or clinically actionable biomarkers will be identified. This can open up options such as targeted therapy or clinical trial enrollment. A separate CE-marked version of TSO Comprehensive is also available in
TSO Comprehensive is FDA approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly's RETEVMO (selpercatinib).
To learn more about TruSight Oncology Comprehensive, click here.
About oncoReveal CDx
Pillar oncoReveal® CDx is an next-generation-sequencing-based IVD kit for the detection of SNVs, insertions, and deletions in 22 genes, intended for previously diagnosed patients with solid tumors. The kit is approved as a CDx to identify patients who may benefit from epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy (class approval) in NSCLC and ERBITUX and VECTIBIX for KRAS in CRC. oncoReveal® CDx is FDA approved on the Illumina MiSeq Dx System.
Use of forward-looking statements
This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; and (iii) legislative, regulatory and economic developments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.
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SOURCE Illumina, Inc.
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