COMPANY:

Invitae Corp

"Invitae...announced its partnership with Epic...Through Aura, Epic's specialty diagnostics suite, Invitae will streamline interactions with provider organizations in the Epic community, making test result information available in providers' usual workflows so that it's easier to use genetic insights to inform treatment decisions."

"Invitae...announced seven studies, including one oral presentation and six posters, to be presented at the 2023 American College of Medical Genetics Meeting held in Salt Lake City from March 14-18, 2023. The research reinforces the importance of universal genetic testing for patients with cancer, with much of the data highlighting the need for increased representation in clinical genetic testing data across racial, ethnic and ancestry groups that have long been underrepresented in genetic studies and databases."

"Mainz Biomed NV...announced today a partnership with Dr Staber & Kollegen GmbH (Labor Staber) as part of its growing network of laboratories offering ColoAlert, its flagship product that is a highly efficacious and easy-to-use at-home screening test for colorectal cancer (CRC)."

"Invitae...announced that its Personalized Cancer Monitoring (PCM™) assay, which helps detect minimal residual disease (MRD) in patients, has obtained its first commercial coverage in all solid tumors by Blue Shield of California. The policy, effective as of March 1, 2023, considers the test medically necessary for patients with stage I-IV cancer after surgical intervention for adjuvant or targeted therapy and/or monitoring for relapse or progression."

"Invitae...announced a partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to use Invitae's Ciitizen natural history data in a retrospective and prospective study of patients diagnosed with cholangiocarcinoma, a rare bile duct cancer....Patients on AstraZeneca's TOPAZ-1 regime and other treatment plans will be followed for the next three years, to determine the long-term efficacy of the currently available treatment options in hopes that higher-quality drugs can be developed leading to better patient outcomes. Data collected will include tolerability of the regimen, autoimmune comorbidities and their impact on outcomes, sequencing of treatments and observation of real-world usage of Abraxane added to TOPAZ-1 backbone."

"Invitae...released a new study in JAMA Network Open, underscoring the clinical utility of the American Society of Breast Surgeons (ASBrS) guidelines recommending universal genetic testing for patients with breast cancer, and showing universal testing improves patient outcomes. Building on a previous study reported in the Journal of Clinical Oncology, the current study is the first clinical outcomes study of a cohort of unselected patients with breast cancer who underwent universal germline genetic testing. Our data show that genetic information aids patients and their physicians in implementing effective precision treatments and personalized management for their cancer."

"Invitae...joined other clinical experts in releasing a new commentary in Journal of Clinical Oncology Precision Oncology, underscoring the importance of universal germline testing for all patients with cancer (solid tumors).The paper reports a meta-analysis of multiple clinical publications supporting universal testing, independent of age, stage, family history or type of cancer."

"As a result of recent research revealing that a significant number of colorectal cancer patients with actionable variants are missed under previous genetic testing guidelines, the National Comprehensive Cancer Network (NCCN) announced new guidelines calling for testing to be available to all patients diagnosed with colorectal cancer. Specifically, NCCN recommended that germline multigene panel testing should be offered to all individuals with CRC age <50 and be considered for all others, particularly for, but not restricted to, those with evidence of mismatch repair in their tumor or suggestive family history. These new recommendations expand the current testing criteria, which limited testing to certain age groups and types of cancer."

"Invitae...announced eight studies to be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from June 3-7, 2022. While the research covers a variety of cancer types, stages and patient demographics, all of the data underscore the importance of universal genetic testing to improve health outcomes for all cancer patients."

"Allelica said on Tuesday that it has formed a partnership with Invitae to develop a breast cancer polygenic risk score (PRS) that can be clinically implemented across multiple ancestries...The collaborators plan to develop and validate this PRS by combining Invitae's genomics data, clinical reach, physician network, and development capabilities with Allelica's ability to analyze multiple datasets using its proprietary software tools."

"Invitae...announced full access to its Personalized Cancer Monitoring (PCM) platform to help detect minimal or molecular residual disease (MRD) in patients with solid tumors. Invitae PCM uses a novel set of personalized assays based on a patient's tumor to detect circulating tumor DNA (ctDNA) in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies."

"Invitae...announced the availability of FusionPlex Dx® and LiquidPlex Dx™ in Europe, part of its industry-leading Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products. Invitae is delivering essential high quality innovation for precision oncology in the fight against cancer."

"Invitae has filed a lawsuit against Natera in the US District Court for the District of Delaware, alleging that the firm infringes two of its patents covering DNA sequence assembly...The company has asserted that Natera has infringed and continues to infringe one or more claims of the ’308 and '863 patents by performing its Signatera cancer liquid biopsy test, which it launched in 2017."

"Invitae plans to add a variety of germline and somatic testing capabilities to its oncology testing pipeline and launch in vitro diagnostic kits to meet growing demand for local cancer testing capabilities in Europe, Asia, and the US...By the end of the year, the company plans to launch expanded DNA-based research-use test kits that assess microsatellite instability and tumor mutation burden, he said. Tests for these biomarkers are in high demand since oncologists can use them to prescribe refractory cancer patients the immunotherapy pembrolizumab (Merck's Keytruda) in a tissue-agnostic fashion."

"Invitae...University College London (UCL), and the Francis Crick Institute today announced new data from their TRACERx lung cancer research collaboration funded by Cancer Research UK and sponsored by UCL...The study used a new blood-based informatic tool called ECLIPSE (Extraction of CLonality from LIquid bioPSiEs) with an earlier iteration of the Invitae Personalized Cancer Monitoring (PCM™) liquid biopsy assay to analyze plasma samples of patients in the TRACERx study."

"Outcomes4Me...said it is working with molecular testing firm Invitae to improve education and access to genetic testing for breast cancer patients and survivors...The latest partnership will now allow patients to make a genetic counseling appointment and order testing directly from Outcomes4Me's platform. Patients can authorize Invitae to report test results directly to the Outcomes4Me platform, within which they can also create a clinical profile."

"Pacific Biosciences of California, Inc...and Invitae Corporation...today announced an intent to expand their multi-year collaboration to develop a production-scale high-throughput HiFi sequencing platform to include the sequencing technology developed by Omniome, Inc."

"Invitae Corporation...today announced it has begun offering early access to its new Personalized Cancer Monitoring (PCM™) platform as a laboratory-developed test performed at an Invitae central laboratory. The service employs a novel combination of a tumor profile, blood tests and personalized assays based on a patient's tumor with the goal of detecting circulating tumor DNA (ctDNA) before it is detectable by imaging or other conventional methods, offering earlier detection of cancer recurrence."

"Invitae Corporation...is presenting multiple studies in multiple cancer types at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting showing all cancer patients can benefit from germline genetic testing to guide their care. The use of genetic information informs changes in cancer care, increases access to precision therapies and guides screening for high-risk individuals and their family members. Earlier detection and precision therapies are critical to increase survivorship for people with cancer, yet the oncology community has been slow to adopt routine testing."

"Invitae…today announced research showing one in six people with colorectal cancer harbor genetic changes that are known to substantially increase the risk for cancer, especially in patients who were younger when diagnosed. The findings are the latest from a landmark study of genetic testing across many solid tumor cancers and were presented at the 2021 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting…The study evaluated the utility of universal multigene panel testing and found the use of multigene panel testing in colorectal cancer was associated with an increased detection of heritable mutations over guideline-based testing. In the study, 361 colorectal cancer patients received germline genetic testing using a panel that included more than 80 genes linked to increased cancer risk."

"Invitae...today announced it has entered into a definitive agreement to acquire Genosity Inc. ("Genosity"), a genomics company offering innovative software and laboratory solutions to enable development and deployment of complex sequencing based tests. The acquisition would bring Genosity's specialized capabilities onto the Invitae platform to accelerate the time to market and decentralization of Invitae's personalized oncology offerings, including somatic and germline offerings poised to help transform how cancer is diagnosed, treated and monitored."

"Invitae…today announced the launch of a new project with Bristol Myers Squibb, Janssen Research & Development, LLC (Janssen), Novartis and Genentech, a member of the Roche Group, to develop a standardized panel for MRD detection in patients with AML to support clinical trial testing across multiple drug development programs. The companies are working together to standardize how MRD data is generated and assessed in clinical trials helping to better establish the clinical utility of MRD as a biomarker in AML."

"Invitae on Monday said that the US Food and Drug Administration has accepted a premarket approval application for the Stratafide next-generation sequencing companion diagnostic. Invitae acquired the test after it bought ArcherDx last month for $1.4 billion. The regulatory submission to the FDA last week triggered a milestone payment, prompting Invitae to issue 5 million shares of its common stock to former ArcherDx security holders."

“ArcherDX, Inc. and Premier Inc., a leading healthcare improvement company, announced today that they have signed a two-part agreement, kicking off a multi-year program….ArcherDX plans to seek approval from the U.S. Food and Drug Administration (FDA) for STRATAFIDE as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients….ArcherDX and Premier's research team will identify retrospective samples from patients with lung, thyroid and colorectal cancer to be analyzed by Archer Clinical Services.”

"Natera, Inc…today reports that the U.S. District Court of Delaware has rejected all of ArcherDX's challenges in Natera's ongoing patent infringement action…The Court's decision upholds the validity of Natera's asserted patents as being directed to eligible subject matter under 35 U.S.C. Section 101. The Court also properly rejected ArcherDX's attempt to remove some of its cancer monitoring products from the case. Natera will continue to prosecute its five-patent infringement case against ArcherDX and will vigorously protect its innovative technology and broad IP claims in the fields of cancer monitoring and multiplex PCR."

"Invitae Corporation...today announced that on October 2, 2020, it completed the transaction to bring ArcherDX...into Invitae to create a comprehensive offering that provides testing services for disease risk, therapy optimization and personalized cancer monitoring to enable precision approaches to cancer treatment...Under the terms of the Agreement and Plan of Merger and Plan of Reorganization, Invitae acquired ArcherDX for upfront consideration consisting of 30.0 million shares of Invitae common stock and $325.0 million in cash, subject to certain adjustments."

"Natera, Inc...filed suit yesterday against ArcherDX, Inc. for infringement of Natera's U.S. Patent No. 10,731,220 (the ''220 Patent'). The complaint was filed in the U.S. District Court of Delaware...The '220 Patent is titled 'Methods for Simultaneous Amplification of Target Loci' and was issued by the United States Patent and Trademark Office on August 4, 2020....Natera's complaint alleges that ArcherDX's sale and use of certain cell-free DNA-based oncology products infringes on the '220 Patent."

"Bayer and ArcherDX, Inc. today announced a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi® (larotrectinib). The primary objective of the collaboration is to broaden patient access to comprehensive genomic testing inclusive of neurotrophic receptor tyrosine kinase 1 (NTRK1), NTRK2 and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer which can lead to meaningful treatment options."

"Natera, Inc...asserted three recently issued oncology patents against ArcherDX in its ongoing patent infringement action filed in the U.S. District Court of Delaware....The United States Patent and Trademark Office recently awarded Natera patents 10,557,172; 10,590,482; and 10,597,708, which cover methods for amplifying and sequencing nucleic acids. Natera's complaint alleges that ArcherDX infringes these patents by selling, manufacturing, and/or using various oncology products, including those in the personalized liquid biopsy space."

“ArcherDX, Inc., today announced that its ArcherMET companion diagnostic (CDx) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical Medical Devices Agency (PMDA) to detect MET exon 14 (METex14) skipping alterations in tissue (RNA) and liquid biopsy (ctDNA) from patients with advanced non-small cell lung cancer (NSCLC) for consideration for treatment with Merck KGaA, Darmstadt, Germany's oral MET inhibitor, TEPMETKO®* (tepotinib).”