COMPANY:

Invitae Corp

"Labcorp...announced today the completion of its acquisition of select assets of Invitae (OTC:NVTAQ), a leading medical genetics company. Together, Labcorp and Invitae will support patients, clinicians and pharmaceutical partners across the continuum of care, including therapy development, patient diagnosis and personalized care."

"Invitae...announced eight studies to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 31-June 4, 2024. The clinical data being presented demonstrate the importance of genetic testing for patients with various different types of cancers, including breast, gastric, prostate and lung, to better inform management and treatment decisions."

"Labcorp...and Invitae...announced...that the United States Bankruptcy Court has approved the previously announced bid by Labcorp to acquire assets of Invitae...The transaction is expected to bolster Labcorp's genetic specialty testing capabilities, especially in key health areas such as oncology and rare diseases, aimed at enhancing patient care and providing insights into their health with improved accessibility to genetic data. The transaction also strengthens Labcorp's ability to utilize genetic data to enhance and support clinical trials and treatment regimens."

"Invitae...announced that Labcorp (NYSE: LH)...has been selected as the winning bidder in the Company's auction in its sale process under Section 363 of the U.S. Bankruptcy Code."

"Invitae...announced new studies to be presented at the American Society of Breast Surgeons Annual Meeting (ASBrS) held in Orlando from April 10-14, 2024. The featured research will highlight how machine learning can reduce variants of uncertain significance (VUS) in patients who have received genetic testing for breast cancer, in addition to results from real world data showing that uncertain results do not lead to an overuse of mastectomies for breast cancer patients."

"Invitae...announced the launch of an update to Invitae Generation™ with Clinical Variant Modeling, a novel machine learning approach designed to aid clinical interpretation of genetic testing results and increase the rate of definitive answers for patients. The first of its kind, developed by a multidisciplinary team of computational biologists, machine learning engineers, clinical experts and geneticists, Clinical Variant Modeling methodically leverages clinical information received at the time of testing to improve variant classification and reduce variants of uncertain significance (VUS)."

"Researchers from Invitae...are showcasing their work next week at the 2024 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in Toronto, Canada from March 12-16. The meeting’s clinical agenda will include presentations on both research and clinical topics that promote the science and practice of clinical genetics and genomics."

"The US District Court for the District of Delaware on Friday ordered that ArcherDx and Invitae permanently stop using products containing material patented by Natera, with certain exceptions."

"Invitae...announced enhanced chemistry of its Invitae Personalized Cancer Monitoring platform that helps detect circulating tumor DNA (ctDNA) as a biomarker for solid tumor malignancies. ctDNA can provide real-time insights on patient response or disease progression, support patient prognostic stratification and enable early detection of residual disease."

"Invitae...announced results of its collaborative study on universal hereditary cancer genetic testing in all patients with breast cancer in a rural population in the Annals of Surgical Oncology."

"Tecan has sued Invitae, ArcherDx, Integrated DNA Technologies, and Qiagen for allegedly infringing on patents related to nucleic acid enrichment and high-throughput sequencing methods...Tecan asserts in the first complaint that its technology underlies what Invitae, ArcherDx, and IDT refer to as their Anchored Multiplex PCR (AMP) target enrichment technology, which is found in Invitae's Personalized Cancer Monitoring (PCM) service and in ArcherDx's LiquidPlex, VariantPlex, and FusionPlex kits."

"Researchers from Invitae...showcasing their work next week at the National Society of Genetic Counselors (NSGC) 42nd Annual Conference in Chicago that highlights the importance of genetics-informed patient care."

"Today, the U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers....The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer....Some of the most clinically significant genes that the test identifies are: BRCA1 and BRCA2, which are genes with known associations to hereditary breast and ovarian cancer syndrome, Lynch syndrome associated genes (MLH1, MSH2, MSH6, PMS2 and EPCAM), CDH1 (mainly associated with hereditary diffuse gastric cancer, and lobular breast cancer) and STK11 (associated with Peutz-Jeghers Syndrome)."

"Lumea Inc...announce our partnership with Invitae Corporation (Invitae). This partnership will give Lumea diagnostic platform users access to easy one-click conditional ordering of Invitae tests."

"Invitae...announced findings from its PROCLAIM trial, published in European Urology Oncology, showing that almost half of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants (PGVs) could be missing out on genetics-informed care due to restrictive criteria for genetic testing."

"Natera, Inc...announced that it has filed a lawsuit in the North Carolina Federal District Court against NeoGenomics Labs, Inc. ('NeoGenomics') for infringement of Natera’s U.S. Patent Nos. 11,519,035 and 11,530,454 by NeoGenomics’ RaDaR molecular residual disease assay."

"Invitae...announced nine studies to be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from June 2-6, 2023. The new research insights highlight innovations in genetic testing in a variety of clinical settings, population groups and cancer types, and reinforce the need to reduce barriers to genetic services to help patients receive the most effective care and monitoring."

"Natera, Inc...announced that a jury in the U.S. District Court for the District of Delaware has reached a unanimous verdict in favor of Natera in the patent infringement suit it filed against ArcherDX/Invitae Corp. The jury found that all accused ArcherDX/Invitae products infringe three of Natera’s patents."

"Invitae...announced that it intends to appeal the verdict delivered by a jury at the United States District Court for the District of Delaware. The jury found that Invitae's products using Anchored Multiplex PCR ('AMP') chemistry infringe certain Natera, Inc. patents. The jury awarded Natera a total of $19.35 million, based on lost profits and a royalty rate of 10% on certain products. Invitae will vigorously defend itself in future proceedings regarding Natera's request for injunctive relief."

"The research technology used in the study leverages a patient-specific panel developed to identify variants from a patient's own tumor rather than a static gene panel....In this publication, sensitivity and specificity of >99.9% was achieved at 0.008% variant allele frequency (AF) with 60ng cfDNA input and 0.03% variant AF with 10ng cfDNA input using a 50 variant patient-specific panel....Clinical specificity was assessed in 61 patients without evidence of disease in whom ctDNA was not expected to be detectable."

"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 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."