COMPANY:

Roche

"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."

"Foundation Medicine, Inc., and Natera, Inc., today announced the broad clinical launch of FoundationOne^®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test to monitor cancer patients’ response to therapy. FoundationOne Tracker is now available to all U.S. healthcare providers for treatment response monitoring (TRM). Additionally, the Centers for Medicare & Medicaid Services’ (CMS) Palmetto GBA Molecular Diagnostics Program (MolDX) has determined, effective June 17, 2023, that FoundationOne Tracker is covered for monitoring of response to immune-checkpoint inhibitor (ICI) therapy, for qualifying Medicare beneficiaries with all solid tumors. FoundationOne Tracker is also approved by the Clinical Laboratory Evaluation Program (CLEP) of New York, which is the only U.S. state that requires an independent regulatory review process for laboratory developed tests."

"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 Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options."

"Roche France, Foundation Medicine, Inc., and the Institute Gustave Roussy...announced...a unique partnership to establish in-house liquid biopsy testing at the Institute Gustave Roussy’s facilities in France, by transferring technology from Foundation Medicine’s FoundationOne Liquid CDx, a blood-based comprehensive genomic profiling (CGP) test."

"Foundation Medicine Inc...announced the launch of the research use and investigational use versions of FoundationOne®RNA, its broad tissue-based RNA test. While DNA sequencing with optimized targeting can detect most fusions, FoundationOne RNA can provide another layer of sophisticated fusion detection in 318 genes through RNA sequencing."

"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 Janssen Biotech, Inc. (Janssen’s) AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)."

"Roche...announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions."

"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 BRAFTOVI^® (encorafenib) in combination with cetuximab which is currently FDA-approved for adult patients with previously treated metastatic colorectal cancer (mCRC) harboring a BRAF V600E alteration. This now makes FoundationOne Liquid CDx the only comprehensive genomic profiling (CGP) test FDA-approved to identify patients with BRAF V600E alterations in mCRC who may be appropriate for treatment with BRAFTOVI in combination with cetuximab."

"Foundation Medicine, Inc...announced that it has entered a strategic collaboration with Merck KGaA, Darmstadt, Germany to develop FoundationOne^®Liquid CDx and FoundationOne^®CDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments. This new agreement builds on the data solutions partnership Merck KGaA, Darmstadt, Germany and Foundation Medicine entered in 2020 to help accelerate the development of novel targeted therapies, individually and in combination. If the companion diagnostic indications are approved, based on tissue availability and the presentation of individual patients, oncologists will be able to use FoundationOne CDx or FoundationOne Liquid CDx to identify those with genomic alterations that may make them eligible for a specific targeted therapy."

"Foundation Medicine, Inc., today announced the launch of its tissue-naïve circulating tumor DNA (ctDNA) monitoring assay, FoundationOne^®Monitor, for research use in retrospective studies. Currently available for biopharma customers, FoundationOne Monitor provides unique access to Foundation Medicine’s ctDNA tumor fraction biomarker that incorporates information to improve sensitivity and maintain high specificity to monitor ctDNA levels."

"Chugai Pharmaceutical Co., Ltd...announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 25, 2023, for FoundationOne®Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for an anti-cancer agent/MET inhibitor, Tabrecta® (generic name: capmatinib hydrochloride hydrate) of Novartis Pharma K.K. (Novartis), which is approved for the treatment of MET exon 14 skipping mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). With this approval, patients with advanced NSCLC who may be eligible for treatment with capmatinib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests."

"Foundation Medicine, Inc., today announced that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6 in Chicago."

"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 EXKIVITY® (mobocertinib), which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy."

"Foundation Medicine, Inc...announced today, an expanded collaboration with Bristol Myers Squibb...to develop Foundation Medicine’s tissue-based test, FoundationOne^®CDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib....'We’re proud to broaden our collaboration with Bristol Myers Squibb as they work to bring this exciting investigational therapy to patients living with ROS1 positive non-small cell lung cancer and NTRK positive solid tumors...'"

"Foundation Medicine, Inc...announced that the company and its collaborators will present a total of 10 studies at the 2023 American Association for Cancer Research (AACR) Annual Meeting from April 14-19 in Orlando, Florida....Results from ctDNA evaluation as early as 6 weeks post treatment initiation were comparable to prostate specific antigen (PSA) response in second line mCRPC, providing an early non-invasive readout that is independent of PSA for monitoring therapy response in late stage mCRPC...Foundation Medicine researchers conducted what is believed to be the largest SCLC study known to date to provide an improved understanding of genetic subtypes in SCLC, including patient ancestry and biopsy site-specific patterns, and better inform mechanisms of transformation to SCLC from non-small cell lung cancer that may further guide the development of personalized therapies for subsets of patients with this fatal tumor."

"Point32Health...and Foundation Medicine...entered into a value-based agreement to make FoundationOne®CDx and FoundationOne®Liquid CDx, FDA-approved comprehensive genomic profiling (CGP) tests, available to Point32Health members with advanced cancer, including Medicaid members."

"Roche...announced today the launch of the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with brain cancer....The two tests are now available in the US. They will likely be available in other non-CE markets later this year and in countries that accept the CE mark in 2024."

"Foundation Medicine, Inc...announced today that UnitedHealthcare commercial plans will cover FoundationOne^®CDx as a companion diagnostic in all solid tumors for patients with unresectable or metastatic cancer being considered for treatment with an immune checkpoint inhibitor and meeting coverage criteria. Additionally, FoundationOne^®Liquid CDx will be covered as a companion diagnostic for patients with advanced breast cancer, metastatic non-small cell lung cancer (NSCLC), recurrent ovarian cancer and metastatic castrate-resistant prostate cancer (mCRPC) meeting coverage criteria. Coverage is effective April 1, 2023....UnitedHealthcare’s planned coverage of FoundationOne CDx and FoundationOne Liquid CDx is in addition to coverage that Foundation Medicine already has for these tests from other national and regional commercial providers, as well as by Medicare and Medicare Advantage plans."

"Foundation Medicine, Inc...announced a global collaboration with Boehringer Ingelheim to develop the company’s tissue-based comprehensive genomic profiling test, FoundationOne^®CDx, as a companion diagnostic for Boehringer Ingelheim’s investigational MDM2-p53 antagonist, BI 907828, in the United States, Japan and European Union."

"Today Foundation Medicine, Inc...announced a global collaboration with Karyopharm Therapeutics Inc. to develop FoundationOne^®CDx as a companion diagnostic for selinexor, which is being evaluated as a front-line maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer."

"Foundation Medicine, Inc and Natera...launched an early access program for clinical use of FoundationOne^®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay. In addition, the investigational use only version of the test is now available for use in clinical trials...FoundationOne Tracker is now available through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023."

"Foundation Medicine, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx to be used as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group."

"Foundation Medicine, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved its FoundationOne^®Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors (TKI) approved by the FDA for this indication."

"Roche...announced US Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE™ (mirvetuximab soravtansine-gynx)....Developed as a predictive biomarker, the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The new test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE....The approval is based on the results of the SORAYA clinical study."