COMPANY:

LabCorp

"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."

"Labcorp...announced...it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx – the industry's first and only kitted, pan-solid tumor liquid biopsy test."

"Labcorp...announced an expanded collaboration with Ultima Genomics to utilize its UG 100TM sequencing solution and ppmSeq technology to explore new whole genome sequencing (WGS) clinical applications, including molecular residual disease (MRD) in patients with early-stage solid tumor cancers."

"Labcorp...announced new strategic service offerings within its precision oncology portfolio. This expansion will extend availability of the service through owned laboratories in Geneva and Shanghai to support research and investigational use in global clinical trials, streamlining access for patients to oncology clinical trials, broadening the patient population, and helping improve logistical efficiencies through Labcorp's global network."

"Labcorp researchers performed comprehensive genomic and immune profiling on 143 formalin-fixed paraffin-embedded breast cancer samples to investigate the interaction between VEGF and immune gene expression. In triple-negative breast cancer (TNBC) samples, VEGF was co-expressed with immune checkpoint genes such as PD-1 and PD-L1...Labcorp researchers performed a targeted RNA-sequence-based assay on 143 breast cancer patient samples, demonstrating that concurrent loss of HLA class I with increased HLA class II expression was associated with co-expression of biomarkers indicative of immune escape but not survival outcomes...Researchers analyzed genomic and gene expression data from over 2,000 colorectal cancer samples to generate and test a model for predicting MSI status, which was confirmed using MSI status from The Cancer Genome Atlas (TCGA) studies of colorectal and endometrial carcinoma."

"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."

"Labcorp...announced...the completion of its acquisition of select assets of Providence’s laboratory business operated by its California medical groups, including ambulatory lab draw stations and an ambulatory laboratory facility and other equipment."

"Labcorp...announced today the strategic expansion of its precision oncology portfolio, solidifying its commitment to advancing cancer research and patient care on a global scale. The announcement underscores Labcorp's dedication to investing in scientific, diagnostic and laboratory innovations to support its pharmaceutical, biotechnology and clinical research partners in bringing groundbreaking therapies to market."

"Labcorp...announced today the launch of Labcorp® Plasma Detect™, the first clinically validated, tumor-informed, whole-genome sequencing circulating tumor DNA (ctDNA) molecular residual disease (MRD) solution in early stage colon cancer to identify patients at increased risk of recurrence after surgery or adjuvant chemotherapy (ACT). This solution, which is designed for research use but also suitable for clinical applications, can be applied across solid tumors with a scalable and standardized approach to facilitate faster turnaround times while maintaining high analytical performance."

"Labcorp...will present abstracts in the areas of immunology, cellular biology, genomics and liquid biopsy at the Annual Meeting of the American Association for Cancer Research® (AACR®) in San Diego (April 5-10, 2024)...Of the 21 abstracts to be presented at the AACR Meeting, 13 were internal studies by Labcorp researchers and eight were conducted in collaboration with research partners from premiere academic institutions and medical centers."

P=NA |N=1,093 | "Consistent with prior prospective clinical trials, researchers reported that the median TTD of first-line PARP inhibitor maintenance therapy was the longest for patients with germline or somatic BRCA mutations or HRD tumors. Among the study groups, 77% of the patients with a germline BRCA mutation, 65.1% of patients with a somatic BRCA mutation, and 42.7% of those with HRD and BRCA wild-type continued PARP inhibitor therapy at 18 months, compared to 29% of patients in the HRP/BRCA wild-type group."

"Labcorp...announced an agreement with Tufts Medicine...for Labcorp to acquire the Tufts Medicine outreach laboratory business and select operating assets as a first step toward a larger strategic partnership...The arrangement will provide patients and clinicians access to Labcorp's scientific expertise and advanced diagnostics in areas such as oncology, neurology and women's health."

"Labcorp...has launched Labcorp Plasma Focus, a new liquid biopsy test enabling targeted therapy selection for patients with advanced or metastatic solid tumors. The test allows treating oncologists to evaluate circulating cell-free DNA (cfDNA) released by tumor cells and better manage the care of their patients through a personalized, targeted therapy plan."

"Proteomedix...announced today that it entered into an agreement for Labcorp, a leading global life sciences company, to be the only laboratory to develop and commercialize the Proclarix® Prostate Specific Antigen (PSA) test in the U.S.. Proclarix is performed using the same blood sample as a PSA test, and is designed to help determine the risk of clinically significant prostate cancer for men with an elevated total PSA and a digital rectal examination that indicates elevated prostate volume, but who are not suspected of having cancer. In appropriate cases, the test provides a non-invasive alternative to a prostate biopsy, which can have significant side effects."

"Labcorp...broke ground on a the expansion project of its CB Trial Laboratory in a ceremony held at the construction site near the BML Research Institute and General Laboratory in Kawagoe City on April 28, 2023...Labcorp will provide technological capabilities that will enable BML to significantly expand its specialty testing capabilities in the areas of genomics, anatomic pathology and histology, as well as the opportunity to partner on emerging companion diagnostics focused on oncology."

"Labcorp...announced it entered into an agreement with Providence to expand the longstanding strategic relationship between the two organizations. Through the agreement, Labcorp will acquire Providence Oregon's outreach laboratory business and select assets in Oregon. Providence Oregon will maintain operation and ownership of certain anatomic pathology and genomics outreach testing and its hospital laboratories in the region."

"Labcorp...announced an agreement to enter into a strategic relationship with Jefferson Health (Jefferson)...When complete, the arrangements between Jefferson and Labcorp will serve to build academic collaborations around teaching and the development of innovative tests...Jefferson and Labcorp will work together to establish the Innovation Driving Excellence in Academics (IDEA) initiative, with a goal of advancing testing capabilities and technologies to improve health outcomes."

"Labcorp...is partnering with the Conference of National Black Churches (CNBC) to address health equity gaps in colorectal cancer screening. To raise awareness and provide expanded access to colorectal cancer screening tests, the Conference of National Black Churches will distribute over 3,000 colorectal screening test kits across several urban and rural locations including Atlanta, Dallas, Memphis, Washington D.C., New Haven, Los Angeles and Richmond."

"Oncology bioinformatics startup VieCure said...that it will integrate its artificial intelligence-backed clinical decision support software with Laboratory Corporation of America's menu of next-generation sequencing tests for cancer diagnosis. Denver-based VieCure said that the strategic collaboration will lead to greater use of precision diagnostics and personalized treatment plans for patients in community health settings."

"Labcorp...announced that it has closed its acquisition of RWJBarnabas Health’s outreach laboratory business and select related assets...Through this collaboration, RWJBarnabas Health’s physicians and patients will be able to access an expanded test menu, as well as Labcorp’s extensive network of patient service centers, which includes Labcorp at Walgreens."

"BD (Becton, Dickinson and Company)...announced a collaboration agreement with Labcorp...creating a framework to develop, manufacture, market and commercialize flow cytometry-based companion diagnostics (CDx) intended to match patients with life-changing treatments for cancer and other diseases...The agreement creates a framework for BD and Labcorp Drug Development to collaborate on flow cytometry-based CDx opportunities with pharmaceutical partners. The two companies bring together capabilities that comprise an end-to-end solution for CDx development for the pharmaceutical industry."

"Labcorp...announced it has formed a strategic partnership with MD Anderson Cancer Center Foundation Spain, a non-profit organization whose objectives are to beat cancer and to increase accessibility of early phase oncology clinical trials. Through this collaboration, oncology clinical trials managed by Labcorp Drug Development will be prioritized and conducted at MD Anderson Cancer Center Foundation Spain, representing a new model for future trials."

"Labcorp...announced a new collaboration to increase clinical trial diversity for women of color and co-create health equity solutions. Labcorp has signed Tigerlily’s #InclusionPledge for Black Women, joining other healthcare and life sciences companies in committing to eradicate barriers for women of color in accessing cancer care and research."

"Labcorp...is announcing a new sponsored testing program aimed at helping advanced non-small cell lung (NSCLC) cancer patients and their physicians make informed treatment and care management decisions through comprehensive genomic insights...The program will use Labcorp’s OmniSeq INSIGHT^SM test, a pan-cancer, tissue-based sequencing test, to provide comprehensive genomic and immune profiling for cases that meet eligibility criteria."

"Finding treatment options for skin cancer may become easier with the launch of a new test by Labcorp...The new test measures Lymphocyte-activation gene 3 (LAG-3) expression levels by immunohistochemistry (IHC) in tumor tissue. LAG-3 is an immune-oncology target with demonstrable clinical benefit in patients with melanoma. The test is available for use in both clinical trials and for the care and treatment of patients."

"Labcorp...announced the launch of Getlabs for Labcorp, an innovative health care service that combines Labcorp’s diagnostic tests with Getlabs phlebotomy service to conveniently test consumers in the comfort of their own homes...The samples can be used for Labcorp’s full range of testing, from standard wellness tests to advanced tests including liquid biopsies for cancer."

"Labcorp...announced that it has closed its acquisition of Personal Genome Diagnostics Inc...The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology."

"Personal Genome Diagnostics Inc...today announced an update to the Proprietary Laboratory Analyses (PLA) code for its comprehensive genomic profiling test, PGDx elio™ tissue complete. The Centers for Medicare & Medicaid Services (CMS) finalized a national reimbursement rate of $2,919.60 for the PLA code (0250U) that PGDx obtained for the test...The new Medicare payment rate went into effect on January 1, 2022."

"GenomOncology announced today that GenomOncology (GO) Pathology Workbench has been selected by Labcorp's OmniSeq to support the analysis and reporting of OmniSeq INSIGHT℠, a comprehensive genomic and immune profiling test for solid tumors....OmniSeq INSIGHT examines the full coding region of 523 genes by next generation sequencing for mutations, copy number alterations, fusions microsatellite instability (MSI), tumor mutation burden (TMB), and expression of 64 immune genes in the tumor microenvironment. The test also includes PD-L1 by immunohistochemistry."

"Laboratory Corporation of America said Thursday that it has agreed to acquire cancer genomics firm Personal Genome Diagnostics (PGDx) for $450 million in cash and $125 million in additional payments based on future performance milestones...Labcorp added that it also plans to offer Baltimore-based PGDx's technology for use in clinical trials of cancer treatments."

“Personal Genome Diagnostics…announced a collaboration with the Center for Immunotherapy and Precision Immuno-Oncology (CITI) and the Cleveland Clinic Lerner Research Institute, Cleveland, Ohio. Both parties will collaborate to enhance capabilities within elioTM plasma complete reporting, as well as collaborate on the development of proprietary methods for complex biomarker detection and assay iterations to meet emerging liquid biopsy applications in solid tumors. This strategic collaboration combines Cleveland Clinic’s world-class research and commitment to innovation with the comprehensive PGDx portfolio and actionable genomic information. Both organizations are driven to elevate the standard of care for patients and increase utilization of precision diagnostics within the cancer care continuum.”

"Personal Genome Diagnostics Inc...reported the publication of a research paper in The Oncologist, titled 'Validation of a ctDNA-based next-generation sequencing assay in a cohort of solid tumor patients: a proposed solution for decentralized plasma testing,' which assessed the performance of the company’s elio™ plasma resolve assay. This is the first study validating that a decentralized plasma-based next-generation sequencing (NGS) test can detect microsatellite instability (MSI) status along with the comprehensive landscape of sequence and structural alterations encountered across solid tumors."

"Tesis Labs...and Personal Genome Diagnostics Inc...announced a new collaboration to maximize the power of genetic sequencing and bioinformatics. Through this collaboration, the companies intend to combine resources and expertise to create new genomics solutions that could combat cancer and improve outcomes for patients, and advance market access initiatives to accelerate adoption in the market."

"Labcorp announced it is expanding its oncology portfolio by acquiring OmniSeq...The transaction bolsters Labcorp’s growing portfolio of diagnostic tests and clinical trial opportunities for people with cancer and the oncologists who treat them...Through the acquisition of OmniSeq, Labcorp enhances its oncology test menu designed to leverage breakthrough science and insights from clinical and patient data to deliver targeted cancer solutions and improve patient outcomes."

"The Access to Comprehensive Genomic Profiling Coalition (ACGP) announced today the addition of Personal Genome Diagnostics (PGDx)...and Sema4...to its coalition of diagnostics companies, laboratory service providers, and CGP industry stakeholders to advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer." "

"Personal Genome Diagnostics Inc. (PGDx) today announced a strategic collaboration with Massachusetts General Hospital (MGH). The two organizations will work closely on the development of innovative solutions aimed at enabling seamless introduction of next-generation sequencing and genomic-based tumor profiling capabilities across a diverse set of clinical operations and laboratory settings...This collaboration will aid in our goal of ensuring this powerful technology is broadly accessible to patients across all types of healthcare settings."

"Personal Genome Diagnostics Inc...today announced a collaborative partnership with the Duke University Health System (DUHS) Clinical Molecular Diagnostics Laboratory. As part of the collaborative partnership, PGDx’s elio™ tissue complete will be the primary technology platform for the laboratory’s clinical oncology genomic testing initiatives. The laboratory will also collaborate with PGDx on the development of next-generation data integration solutions aimed at optimizing clinical usability of genomic data and insights across the cancer care continuum."

"Personal Genome Diagnostics Inc. (PGDx)...today announced the launch of elio™ (empowering local insight for oncology) plasma complete, a NGS kit solution for comprehensive blood-based genomic analysis. The elio™ plasma complete kit is intended to support research in areas like biomarker discovery, therapy selection, and monitoring, and is ideal for investigating genetic mutations and genomic signatures in multiple cancer types."

"OmniSeq said on Tuesday that it has received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program for its Insight cancer genomic and immune profiling test...With the approval, the test, which detects genomic variants, genomic signatures, and immune gene expression to inform cancer treatment decisions, will be available to patients in New York."

"Personal Genome Diagnostics Inc. (PGDx)…today announced a strategic collaboration with Fox Chase Cancer Center in Philadelphia for the PGDx elio™ plasma resolve liquid biopsy panel. The strategic collaboration combines the world-class Fox Chase research and clinical expertise in the community healthcare setting with PGDx leadership in the development of comprehensive genomic products that can be distributed and used in laboratories worldwide, wherever patients seek treatment for their cancer. Both organizations are driven by the overall goal of bringing the highest standards of care to patients in communities across the globe."

"Personal Genome Diagnostics Inc. (PGDx)...announced today that it has entered into a collaboration with QIAGEN to provide comprehensive genomic profiling tests and clinical decision support to molecular labs. Under the non-exclusive agreement, PGDx will be responsible for the distribution of the PGDx elio™ oncology products and kitted solutions. Laboratories that purchase the PGDx elio products will have an option to receive from QIAGEN standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories will receive access to QIAGEN’s QCI Interpret One for rapid, evidence-based reporting for next-generation sequencing (NGS) oncology tests at scale."

"PGDx and Almac Diagnostic Services will focus on providing access to tumor profiling assays for both tissue and plasma samples, specifically, PGDx elio™ tissue complete and PGDx elio™ plasma resolve. This collaboration will combine Almac’s world-class genomics services and expertise in development and delivery of molecular diagnostics with PGDx’s leadership in cancer genomics to accelerate solutions that will deliver precision medicine to more patients."