COMPANY:

Roche

"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)."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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'."

"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."

"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."

"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)."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"AnHeart Therapeutics...and Foundation Medicine, Inc., today announced the companies have entered a strategic collaboration for the development and regulatory approval of Foundation Medicine’s tissue-based and liquid-based comprehensive genomic profiling tests, FoundationOne^®CDx and FoundationOne^®Liquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States....Taletrectinib is a potential best-in-class ROS1 inhibitor being evaluated for the treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), an underserved group of lung cancer patients in need of new options."

"Roche...announced today the launch of the LightCycler® PRO System based on the proven gold-standard technology of the LightCycler® Systems that came before it. This new system raises the bar for performance and usability while bridging the gap between translational research and in-vitro diagnostics. The LightCycler PRO System further complements Roche's molecular PCR testing portfolio which includes solutions for a variety of healthcare professionals – from those performing research to those testing patients for cancer, infectious diseases and other public health challenges."

"Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy...CAPItello-291, a double-blind, phase 3, randomized trial showed that the addition of capivasertib to fulvestrant therapy resulted in a significant improvement in progression-free survival among patients with HR-positive, HER2-negative PIK3CA/AKT1/PTEN-altered advanced breast cancer..."

"Foundation Medicine, Inc., and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne^®CDx and FoundationOne^®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC). The companies will work collaboratively to seek the regulatory approval for Foundation Medicine assays which detect mutations including BRAFV600E to identify patients for potential treatment with Pierre Fabre Laboratories’s BRAF/MEK inhibitor combination regimen, BRAFTOVI^® (encorafenib) and MEKTOVI^® (binimetinib), in the European Union."

"Roche announced today the recent U.S. Food and Drug Administration (FDA) approval of the cobas® HPV test for use on its next-generation cobas® 5800 molecular instrument. This new approval will broaden access to HPV testing in mid-size and smaller labs in the U.S. to help enable accurate and timely diagnosis of patients who are at risk of developing cervical cancer."

"Foundation Medicine, Inc...announced its participation in the National Cancer Institute’s (NCI) Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH) initiative to test new therapy combinations in select groups of adults and children with cancer."

"Roche...announced today collaborations with Ibex Medical Analytics and Amazon Web Services, enabling pathology laboratories to access Ibex’s AI-powered decision support tools to support clinicians in breast and prostate cancer diagnosis through the navify^® Digital Pathology software platform."

"Foundation Medicine...announced that it has expanded its partnership with Sequanta Technologies Co., Ltd. ('Sequanta') to provide genomic profiling services to support clinical research and the development of oncology therapies in China."

"Foundation Medicine Inc. and Roche...announced that they will present the results from a randomized, global precision oncology study designed to prospectively assess the efficacy and safety of molecularly-guided therapy for patients with unfavorable subset cancer of unknown primary (CUP). The results will be presented as a late breaking abstract on Saturday, October 21 at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain."

"Foundation Medicine, Inc., today announced that the company will present 11 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting from October 20-24 in Madrid, Spain...In a late-breaking abstract, Foundation Medicine and Roche share results from the randomized precision oncology study, CUPISCO, designed to prospectively assess the efficacy of molecularly guided therapy for patients with unfavorable subset cancer of unknown primary (CUP)....Two new studies being presented by Foundation Medicine and its collaborators at ESMO highlight the differentiated ctDNA tumor fraction reporting capabilities of the company’s FoundationOne^®Liquid CDx test."

"Foundation Medicine Inc...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 Pfizer’s BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation."