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COMPANY:
Roche

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Related tests:
Evidence

News

23d
Foundation Medicine to Launch Hereditary Germline Tests, FoundationOne Germline and FoundationOne Germline More, in the United States Through a Partnership with Fulgent Genetics (Businesswire)
"Foundation Medicine...announced plans to launch two new germline tests, FoundationOne Germline and FoundationOne Germline More, in the United States to identify genetic variants associated with hereditary cancers and can be used by healthcare providers to understand underlying risks for patients and their families. These tests will be offered through a partnership with Fulgent Genetics....The companies are planning for healthcare providers to be able to add FoundationOne Germline or FoundationOne Germline More to any Foundation Medicine comprehensive genomic profiling test, through Foundation Medicine's portal beginning February 28, 2025."
Licensing / partnership
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FoundationOne® Germline • FoundationOne® Germline More
27d
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU (Roche Press Release)
"Roche...U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU®."
Approval
|
PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
1m
U.S. Food and Drug Administration Approves FoundationOne CDx as a Companion Diagnostic for OJEMDA (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients (Businesswire)
"Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA."
FDA approval
|
BRAF (B-raf proto-oncogene)
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FoundationOne® CDx
|
Ojemda (tovorafenib)
1m
U.S. Food and Drug Administration Approves FoundationOne CDx as a Companion Diagnostic for OJEMDA (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients (Businesswire)
"Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA."
FDA approval
|
BRAF (B-raf proto-oncogene)
|
FoundationOne® CDx
|
Ojemda (tovorafenib)
1m
U.S. Food and Drug Administration Approves FoundationOne CDx as a Companion Diagnostic for OJEMDA (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients (Businesswire)
"Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA."
FDA approval
|
BRAF (B-raf proto-oncogene)
|
FoundationOne® CDx
|
Ojemda (tovorafenib)
3ms
Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA (PRNewswire)
"Roche...announced...the U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test. This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii)."
FDA approval
|
PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
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Ziihera (zanidatamab-hrii)
3ms
U.S. Food and Drug Administration Approves FoundationOne Liquid CDx as a Companion Diagnostic for TEPMETKO (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer (Businesswire)
"Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne Liquid CDx to be used as a companion diagnostic for TEPMETKO (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada....FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO."
FDA approval
|
FoundationOne® Liquid CDx
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Tepmetko (tepotinib)
3ms
Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE (PRNewswire)
"Roche...announced today that it has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. This is the first immunohistochemistry (IHC) companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE (mirvetuximab soravtansine). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by AbbVie for the treatment of FRɑ-positive platinum-resistant ovarian cancer."
European regulatory
|
VENTANA FOLR1 RxDx Assay
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Elahere (mirvetuximab soravtansine-gynx)
4ms
Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY (PRNewswire)
"Roche...announced today that the VENTANA CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOY (zolbetuximab)....VYLOY is the first FDA-approved treatment specifically targeting HER2-negative locally advanced unresectable or metastatic gastric or GEJ cancer patients whose tumours are CLDN18.2-positive."
FDA approval
|
VENTANA CLDN18 (43-14A) Assay
|
Vyloy (zolbetuximab-clzb)
5ms
U.S. Food and Drug Administration Approves FoundationOneLiquid CDx as a Companion Diagnostic for Itovebi (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation (Businesswire)
"Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy."
FDA event
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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FoundationOne® Liquid CDx
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Itovebi (inavolisib)
5ms
Roche obtains CE certification for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY (GlobeNewswire)
"Roche...announced today that the VENTANA CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOY (zolbetuximab)...The new VENTANA CLDN18 (43-14A) RxDx Assay can help determine CLDN18.2 status and inform clinicians about the likelihood of patients benefiting from CLDN18.2 targeted therapy...The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is based on the results of the SPOTLIGHT and GLOW clinical studies where it was used as the enrollment assay to identify patients whose tumours were CLDN18.2 positive."
Commercial • European regulatory
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VENTANA CLDN18 (43-14A) Assay
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Vyloy (zolbetuximab-clzb)
5ms
Foresight Diagnostics founders respond to Roche lawsuit, says claims asserted in bad faith (Precision Medicine Online)
"Foresight Diagnostics founders Maximilian Diehn and Arash Ash Alizadeh, as individuals, said in a court document filed on Wednesday in the US District Court for the Northern District of California that the claims made by Roche in a lawsuit concerning trade secrets are meritless and untimely."
Corporate lawsuit
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Foresight CLARITY™
5ms
Foundation Medicine awarded contract by the U.S. Department of Veterans Affairs to provide tumor molecular profiling to Veterans with cancer (Foundation Medicine Press Release)
"Foundation Medicine, Inc...announced it was awarded its second consecutive, five-year contract by the U.S. Department of Veterans Affairs (VA) to provide tumor molecular profiling tests and services to eligible Veterans living with cancer as part of the VA’s National Precision Oncology Program. The national contract covers Foundation Medicine’s tissue-based test FoundationOne®CDx, liquid-based test FoundationOne®Liquid CDx, tissue-based RNA sequencing test FoundationOne®RNA and FoundationOne®Heme for hematologic malignancies."
Clinical
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FoundationOne® CDx • FoundationOne® Liquid CDx • FoundationOne® Heme CDx • FoundationOne®RNA
5ms
WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche’s role in pioneering cervical cancer solutions (Roche Press Release)
"Roche...announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer."
Clinical guideline
|
CINtec® PLUS Cytology
6ms
Massive Bio and Foundation Medicine partner to optimize clinical trial recruitment and enrollment to expand access to precision cancer care (Businesswire)
"Massive Bio...and Foundation Medicine, Inc...announced a strategic collaboration to increase patient access to cutting edge clinical trials. This collaboration unites Massive Bio’s patient matching technology and last-mile solutions with Foundation Medicine’s global expertise and leadership in next generation sequencing (NGS) and network of healthcare providers."
Licensing / partnership
6ms
Lunit Joins Roche’s Digital Pathology Open Environment to Advance Cancer Biomarker Testing (PRNewswire)
"Lunit...announced its collaboration with Roche to integrate Lunit SCOPE PD-L1 22C3 TPS into Roche's navify Digital Pathology platform. This marks the first deployment of Lunit's AI technology with Roche, supporting pathologists and scientists with enhanced tools for cancer research as part of Roche's initiative to create a collaborative digital pathology ecosystem....The collaboration spans significant global territories, starting with the US, with future expansion targeted for Canada, the EU (UK), Korea, and Japan, underscoring the strategic intent to enhance cancer diagnostics and treatment across diverse healthcare markets. Lunit SCOPE PD-L1 22C3 TPS is an AI-powered tool that provides high-value insights and analysis of the PD-L1 tumor proportion score (TPS), a critical biomarker in cancer immunotherapy."
Licensing / partnership
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Lunit SCOPE PD-L1
6ms
Foundation Medicine Partners with Syndax to Develop a Companion Diagnostic in Hematology and Support Efforts to Pursue Regulatory Approval for an Assay Based on the FoundationOne Heme Platform (Businesswire)
"Foundation Medicine, Inc. today announced a collaboration with Syndax Pharmaceuticals...to develop a companion diagnostic for the identification of acute myeloid leukemia (AML) patients harboring an NPM1 mutation. As part of the collaboration, Syndax will also support Foundation Medicine’s efforts to pursue regulatory approval of an assay based on the FoundationOne Heme platform....If approved, the assay could be the first next-generation sequencing companion diagnostic to detect genomic alterations in hematologic neoplasms, including enhancing the identification of patients with NPM1 mutations who may be eligible for revumenib."
Licensing / partnership
|
FoundationOne® Heme CDx
|
Revuforj (revumenib)
6ms
U.S. Food and Drug Administration Approves FoundationOne CDx and FoundationOne Liquid CDx as Companion Diagnostics for Lynparza (olaparib) in Combination with Abiraterone for Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (Businesswire)
"Foundation Medicine...announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx and FoundationOne Liquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2 and/or ATM alterations in mCRPC."
FDA approval
|
FoundationOne® CDx • FoundationOne® Liquid CDx
|
Lynparza (olaparib)
6ms
Foundation Medicine Collaborates With Merus to Advance Treatment Options in NRG1 Fusion-Driven Tumors Using Foundation Medicine’s RNA Platform (Businesswire)
"Foundation Medicine...announced a collaboration to develop Foundation Medicine’s RNA platform as a companion diagnostic for Merus N.V.’s...bispecific antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion (NRG1+) cancer. Zeno is a Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer)....'We anticipate this innovative molecular information will help detect more NRG1 fusions and provide healthcare providers with important information to inform their care decisions for patients'."
Licensing / partnership
|
Bizengri (zenocutuzumab-zbco)
7ms
Roche closes acquisition of LumiraDx’s Point of Care Technology to expand access to diagnostic testing in primary care (Roche Press Release)
"Roche...announced today the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Roche will now embark on the full integration of the company’s innovative multi-assay point of care platform and the related R&D, operational and commercial sites into its global organisation."
Licensing / partnership
7ms
Ipilimumab plus nivolumab (Ipi+Nivo) in patients with tumors harboring high tumor mutational burden or load (TMB/TML-H): Results from the Drug Rediscovery Protocol (DRUP) (ESMO 2024)
P2 | "Ipi+nivo showed notable efficacy and impressive mDOR in pts with TMB/TML-H tumors across tumor types. Higher TMB/TML correlated with CB, offering further opportunities to refine patient selection."
Clinical
|
TMB (Tumor Mutational Burden)
|
TruSight Oncology 500 Assay • Oncomine Tumor Mutation Load Assay
|
Opdivo (nivolumab) • Yervoy (ipilimumab)
7ms
Gene rearrangements, actionability and access to precision medicine: Results from the ARCAGEN study (ESMO 2024)
P=N/A | "Rearrangements in rare cancers have at least, a similar rate as in common cancers and can be targeted. However, despite identification of the alterations, treatment access remains limited."
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • FGFR2 (Fibroblast growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
|
FoundationOne® CDx • FoundationOne® Liquid CDx • FoundationOne® Heme CDx
8ms
Roche Sues Foresight Diagnostics, stanford over cancer detection technology (Precision Medicine Online)
"Roche has sued cancer detection startup Foresight Diagnostics and Stanford University for allegedly stealing trade secrets related to cancer detection and genetic sequencing technology...The lawsuit was filed on Monday in the US District Court for the Northern District of California and alleged that Foresight founders and Stanford professors Maximilian Diehn and Ash Alizadeh secretly created Foresight while working as Roche consultants with noncompete contracts and confidentiality agreements and stole Roche technology."
Corporate lawsuit
8ms
U.S. Food and Drug Administration (FDA) Approves FoundationOne Liquid CDx as a Companion Diagnostic for AKEEGA (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer (Businesswire)
"Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne Liquid CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC)."
FDA event
|
FoundationOne® Liquid CDx
|
Akeega (abiraterone/niraparib)
8ms
Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection (Roche Press Release)
"Roche...announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche’s HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems."
Approval
|
cobas® HPV test
8ms
Roche launches new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma (Roche Press Release)
"Roche...launch of the first clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection."
Launch Europe • Approval
|
VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay
9ms
Foundation Medicine Announces Partnership with Repare Therapeutics to Provide Genomic Profiling Services to Support Clinical Trials and to Develop Companion Diagnostic for Lunresertib (Businesswire)
"Foundation Medicine...announced that it has formed a collaboration with Repare Therapeutics, a leading clinical-stage precision oncology company, to provide prospective genomic profiling to patients in Repare’s ongoing Phase I/Ib MYTHIC study (NCT04855656) of lunresertib alone or in combinations in genomically-defined patient populations. The companies are also exploring opportunities to develop FoundationOne CDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program....Foundation Medicine is the global leader in companion diagnostic approvals with approximately 60% of all U.S. companion diagnostic approvals for next generation sequencing testing."
Licensing / partnership
|
FoundationOne® CDx
|
lunresertib (RP-6306)
9ms
Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator (GlobeNewswire)
"Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc...announced a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation."
Licensing / partnership
|
FoundationOne® CDx
|
rezatapopt (PC14586)
9ms
Chugai obtains approval for FoundationOne Liquid CDx Cancer genomic profile to provide information on detection of copy number alterations of cancer-related genes and bTMB score (Chugai Press Release)
"Chugai Pharmaceutical Co...announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 23, 2024, for FoundationOne Liquid CDx Cancer Genomic Profile to provide information on detection of copy number alterations of cancer-related genes and blood tumor mutational burden (bTMB) score."
Japan approval
|
FoundationOne® Liquid CDx
9ms
Foundation Medicine Launches RNA Sequencing Test, FoundationOne RNA, in the U.S. (Businesswire)
"Foundation Medicine, Inc., today announced the U.S. launch of FoundationOne RNA, a tissue-based RNA sequencing test for the detection of cancer-related fusions across 318 genes. FoundationOne RNA enables reporting of fusions in all solid tumors and may be valuable for detecting fusions in certain cancers, such as non-small cell lung cancer (NSCLC), pancreatic cancer, cholangiocarcinoma, sarcoma, thyroid cancer and bladder cancer. This test was made available to researchers in September 2023 for research and for investigational use, and today is being launched for clinical use."
Launch • Launch US
|
FoundationOne®RNA
11ms
Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU (PRNewswire)
"Roche...announced today the approval of the CE Mark for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU (trastuzumab deruxtecan) may be considered as a targeted treatment....The VENTANA HER2 (4B5) test now includes a scoring algorithm that helps pathologists to identify 'low expressors' of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test is able to identify patients who may benefit from ENHERTU as a treatment option....The CE Mark of the new HER2-low indication expands on the intended use for Roche's proven, on-market VENTANA HER2 (4B5) test, delivering timely, clear and confident results."
European regulatory • Commercial
|
PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
11ms
Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile to Be Used as a Companion Diagnostic for the AKT Inhibitor, Capivasertib for Advanced HR-positive, HER2-negative Breast Cancer with PIK3CA, AKT1 or PTEN Alterations (Chugai Press Release)
"Chugai Pharmaceutical Co., Ltd...announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 20, 2024, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic to identify patients eligible for AstraZeneca K.K.’s AKT inhibitor, Truqap tablets (generic name: capivasertib), in combination with Faslodex (generic name: fulvestrant) for patients with advanced unresectable or recurrent HR-positive, HER2-negative breast cancer with specific PIK3CA, AKT1 or PTEN alterations, which was approved by the MHLW on March 26, 2024....The efficacy and safety of the combination therapy of capivasertib and fulvestrant in this specific form of breast cancer was evaluated in the global phase III CAPItello-291 study."
Japanese regulatory
|
FoundationOne® CDx
|
Truqap (capivasertib)
12ms
New ASCCP cervical cancer management guidelines now include dual-stain triage testing with Roche’s CINtec PLUS Cytology to enable earlier diagnosis (PRNewswire)
"Roche Diagnostics today announced the release of new guidelines from ASCCP and other members of the Enduring Guidelines for Cervical Cancer Screening and Management Committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus (HPV) infection is transforming into cervical pre-cancer."
Clinical guideline
|
CINtec® PLUS Cytology
12ms
Foundation Medicine Announces Details of Presentations at the 2024 American Association for Cancer Research (AACR) Annual Meeting (Businesswire)
"Foundation Medicine, Inc...announced that research from its robust oncology diagnostics portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California April 5-10, 2024....In a retrospective study of 58 patients from the Genentech, a member of the Roche Group, MyPathway study (NCT02091141)...Results suggest ​serial early ctDNA monitoring ​is a valuable complementary tool for real-time treatment response monitoring to targeted therapy....Leveraging plasma collected serially from patients in Genentech’s Prospective Clinico-Genomic (PCG) study (NCT04180176), the FoundationOne Monitor assay was used to investigate ctDNA tumor fraction for monitoring treatment response."
P2 data • Retrospective data
|
FoundationOne® CDx • FoundationOne®Monitor • FoundationOne®Tracker
12ms
Chugai obtains approval for FoundationOne CDx cancer genomic profile to be used as a companion diagnostic for RET receptor tyrosine kinase inhibitor, Selpercatinib for RET fusion-positive solid tumors (Chugai Press Release)
"Chugai Pharmaceutical...announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 28, 2024, for FoundationOne®CDx Cancer Genomic Profile to be used as a companion diagnostic for Eli Lilly Japan K.K.’s RET (rearranged during transfection) receptor tyrosine kinase inhibitor, Retevmo capsules (generic name: selpercatinib), for RET fusion-positive solid tumors."
Japanese regulatory
|
FoundationOne® CDx
1year
Freenome Raises $254 Million in New Funding to Accelerate its Platform for Early Cancer Detection (PRNewswire)
"Freenome...announced the addition of $254 million from new and existing investors. The funding enables Freenome to advance the pipeline of single-cancer and tailored multi-cancer early detection tests built on its multiomics platform....Freenome is leveraging its multiomics platform, which uses computational biology, machine learning and other technologies to develop screening tools to detect cancer in its earliest, most treatable stages. The platform is also being evaluated alongside Freenome's biopharma and diagnostic company partners to non-invasively detect minimal residual disease (MRD) augmented with biological insights derived from the multiomics platform."
Financing
1year
Roche, PathAI partner to develop digital pathology algorithms for companion diagnostics (Precision Medicine Online)
"Roche announced on Tuesday that it has entered into an agreement with PathAI to develop digital pathology algorithms for companion diagnostics...Under the agreement, PathAI will exclusively work with Roche Tissue Diagnostics to develop artificial intelligence-enabled digital pathology algorithms in the companion diagnostics space, Roche said in a statement."
Licensing / partnership
1year
Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile to Be Used as a Companion Diagnostic for PARP Inhibitor, Talazoparib, Which is Approved for BRCA Gene Mutation-Positive Castration-Resistant Prostate Cancer with Distant Metastases (Chugai Press Release)
"Chugai Pharmaceutical...announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 2, 2024, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for...TALZENNA capsules...which is approved for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases....This approval enables the detection of BRCA1/2 gene mutations using the FoundationOne CDx Cancer Genome Profile to assist of the decision to use talazoparib for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases. The efficacy and safety of combination therapy of talazoparib and enzalutamide for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases was evaluated in the global phase III study TALAPRO-2. Pfizer Japan Inc. obtained approval from the MHLW on January 18th, 2024."
Japanese regulatory
|
FoundationOne® CDx
|
Talzenna (talazoparib)