???End of 2024 News Round-Up???

With the end of the year being a busy period I have combined the news updates from November and December in this newsletter. This will be a longer read than normal.

November

German molecular diagnostics and rare disease company CENTOGENE plans to sell its business to an affiliate of Charme Capital Partners , a European private equity group, for €8.7 million.

Maravai LifeSciences a global provider of life science reagents and services to researchers and biotech innovators, announced that it has signed an agreement to acquire the DNA and RNA business of Officinae Bio, part of Maravai LifeSciences .

Microbiologics , a specialist in infectious disease reference materials and contract research services, announced the acquisition of SensID GmbH , a manufacturer of reference materials and quality controls for molecular diagnostics with a focus on oncology and precision medicine.

Taconic Biosciences , a leader in genetically engineered rodent models and services, announces expanded mouse model production and colony management services with the opening of a new U.S. West Coast facility based in Seattle, WA.

Avantor opens new Bridgewater Innovation Center focused on solving life science’s biggest challenges

December

OraSure Technologies , a leader in point-of-need and home diagnostic tests and sample management solutions, announced the acquisition of Sherlock Biosciences a global health company bringing next-generation diagnostics to consumers and healthcare providers.

Singular Genomics has entered into a definitive agreement to be acquired by Deerfield Management for $20 per share in an all-cash transaction.

Quanterix is acquiring Georgetown, Texas-based magnetic bead manufacturing firm Emission iNC for up to $70 million.

Quantum-Si and Canaccord Genuity Group Inc. enter agreement to sell up to $75M in common stock in at-the-market offering. The company also announced it has terminated a similar agreement entered into with Evercore Group in August 2023.

LGC has acquired DiaMex GmbH , a German manufacturer of third-party serology and molecular quality controls for clinical laboratories and blood banks, for an undisclosed amount.

November

Jury awards Guardant Health $292.5M in false advertising lawsuit against Natera . The companies have both claimed that the other has engaged in false advertising related to Signatera and Reveal MRD assays.

Zymo Research Corp has filed an amended response and counterclaims in a lawsuit brought against it by 凯杰 in August for allegedly infringing patents related to nucleic acid sample preparation.

Oxford Nanopore Technologies has withdrawn an ex parte court application to serve subpoenas to Complete Genomics , Innomics Inc. (formerly known as BGI Americas), MGI Americas, and other entities to support a lawsuit the company intends to file in the courts of England and Wales.

December

Foresight Diagnostics , 美国斯坦福大学 , and three individual defendants last week filed motions in the US District Court for the Northern District of California to dismiss 罗氏公司 's claims in an ongoing lawsuit concerning trade secrets.

10x Genomics , a leader in single cell and spatial biology, announced it had secured a permanent injunction in the U.S. District Court for the District of Delaware against the GeoMx products sold by Bruker , which acquired the product line from NanoString Technologies, Inc. . To minimize the risk of disruption to ongoing research, 10x Genomics requested a carve-out for GeoMx users who installed an instrument prior to the trial in November 2023.

November

Advanced Genomics APAC & 3BIGS CO., LTD. partner on cancer testing in Asia-Pacific

Oxford Nanopore Technologies has inked a partnership with the UK Biobank to create a large-scale epigenetic dataset that will become publicly available.

Oxford Nanopore Technologies has also struck a partnership with the UK government to improve genomics research and healthcare as well as biosecurity surveillance for the country.

Oxford Nanopore Technologies and Wasatch Biolabs (WBL) are collaborating to develop direct whole-methylome sequencing (dWMS).

Breakthrough Genomics has partnered with the Pancreatic Cancer Early Detection (PRECEDE) Consortium on the validation of the company's liquid biopsy test for the early detection of pancreatic cancer.

Illumina is adding Myriad Genetics ' Genomic Instability Score (GIS) to its TruSight Oncology 500 v2 (TSO 500 v2) assay.

Leader Life Sciences will distribute Bio-Techne 's portfolio in Middle East

Tagomics has signed a strategic comarketing agreement with 安捷伦 to offer their respective genomic profiling and epigenetic profiling technologies through Tagomics' service lab in the UK.

23andMe partnered with Mirador Therapeutics to identify therapeutic targets and develop drugs for chronic immune-mediated inflammatory and fibrotic diseases.

Quantum-Si announced several deals facilitating the development and production of a new proteomics platform, as well as a distribution agreement for its existing products. The company signed deals with Planet Innovation , SkyWater Technology , and 英伟达 for development work on a new proteomics platform called Proteus. Avantor will distribute Quantum-Si's existing protein sequencing products in the US and Canada.

Alamar Biosciences, Inc. has entered a strategic collaboration with the The Michael J. Fox Foundation for Parkinson's Research for Parkinson's disease research.

Stilla Technologies inked a strategic partnership Source BioScience to bring its digital PCR technology to the UK and Ireland.

Bio-Techne has partnered with ALZpath Inc. to develop the Simple Plex Human Phospho-Tau (T217) Alzpath Assay for neurodegenerative disease research.

Sapio Sciences has entered a comarketing agreement with Waters Corporation . The companies will co-market Sapio's LIMS software with Waters' waters_connect software for LC-MS quantitation.

Cure51 is collaborating with Cambridge University Hospitals NHS Foundation Trust and seven other UK-based cancer institutions to launch its Rosalind cancer survival study in the UK.

Genomadix has entered into a license agreement with Mayo Clinic under which the two will collaborate on the delivery of enhanced telestroke services in the US.

凯杰 has formed a collaboration with 加拿大麦吉尔大学 's Centre for Microbiome Research, spanning three years, the collaboration will focus in part on DNA extraction from samples with low microbial biomass and culturing protocols for anaerobes.

Tempus AI has inked a deal with Roche's Flatiron Health that will allow healthcare providers to order Tempus' genomic cancer tests through Flatiron's electronic medical record system

Promega Corporation and QuantumCyte, Inc. announced an agreement to jointly market a clinical lab workflow comprising QuantumCyte's QCPrecise automated microdissection platform alongside Promega's Maxwell CSC and ReliaPrep nucleic acid purification platforms.

Mainz Biomed has signed a collaborative agreement with 赛默飞世尔科技 , through its subsidiary Life Technologies, to develop and potentially commercialize a new colorectal cancer screening test.

Canhelp Genomics is collaborating with Mirxes to provide solid tumor origin identification testing services in Singapore, Malaysia, Thailand, Indonesia, and the Philippines.

Inocras Inc. has signed a memorandum of understanding with Tokyo-based Summit Pharmaceuticals Europe S.r.l. to integrate WGS into Japan's healthcare system.

Seer announced a co-marketing and sales agreement with 赛默飞世尔科技 to jointly promote Seer’s Proteograph? Product Suite alongside Thermo Scientific Orbitrap Astral? mass spectrometers.

GenomOncology and Genomenon, Inc announced a strategic partnership aimed at streamlining germline variant classification and genomic reporting

MGI partners with the Human Cell Atlas to further advance worldwide human cell mapping efforts

TEVOGEN BIO expands on 微软 partnership to integrate machine learning and AI into preclinical processes, accelerating drug development and reducing costs

Lumea and Caris Life Sciences have agreed to make Caris' sequencing-based urology tools available through Lumea's BxLink digital pathology platform.

December

Dapu Biotechnology (DPBIO) and Leveragen , Inc have announced a strategic partnership to accelerate innovations in antibody drug development.

Scailyte and Visterra Inc. , Inc announced a research collaboration with the goal to accelerate the development of innovative treatments for autoimmune diseases.

Parse Biosciences announced that Admera Health has been certified as part of Parse’s Certified Service Provider (CSP) program.

Illumina and Macrogen Inc. are collaborating to sequence and analyze 145,952 genomes as part of South Korea's National Bio Big Data project.

Quest Diagnostics and Mainz Biomed have entered an agreement for Quest to provide clinical trial lab services for Mainz Biomed's ColoAlert colorectal cancer screening test.

Guardant Health has entered a new partnership with MiBA that pairs Guardant's biomarker testing data and MiBA's analytics to advance precision medicine across the MiBA Network.

Real-world data firm COTA has teamed up with Guardant Health to provide biopharmaceutical researchers access to a combined database that will include its own electronic health record data and Guardant’s genomic testing results from cancer patients.

The Davos Alzheimer's Collaborative (DAC) is partnering with Janssen Inc. Research & Development and Danaher subsidiary 贝克曼库尔特 to validate blood-based biomarkers for Alzheimer's disease.

Guardant Health has entered into a collaboration with 勃林格殷格翰 to pursue regulatory approval and commercialization of its Guardant360 CDx liquid biopsy assay as a companion diagnostic for Boehringer's investigational drug zongertinib in lung cancer.

Illumina and Ovation are collaborating on generating genomic data from patient samples for clinical research outside of oncology.

Personalis, Inc. and Tempus AI have expanded their partnership to jointly commercialize Personalis' NeXT Personal Dx minimal residual disease (MRD) assay to reach biopharmaceutical customers.

Akoya Biosciences, Inc. has inked an exclusive global license agreement with NeraCare to develop and commercialize NeraCare’s Immunoprint test for early-stage melanoma on Akoya's immunofluorescence platform.

澳大利亚墨尔本大学 and the Peter MacCallum Cancer Centre announced a joint venture to establish the Collaborative Centre for Genomic Cancer Medicine.

DNAnexus inked a partnership Panomics to offer a cloud-based data analysis platform for biopharma customers for biomarker discovery and drug development.

Natera and MyOme have partnered to launch a cross-ancestry, integrated polygenic risk score (iPRS) for five-year and lifetime breast cancer risk.

BeiGene has entered a new partnership with CLL Society , a nonprofit organization focused on chronic lymphocytic leukemia and small lymphocytic lymphoma, to promote upfront biomarker testing to guide the use of targeted therapies in these cancers.

Esya Labs has partnered with Alamar Biosciences, Inc. to help detect and quantify biomarkers for neurological, inflammatory, and neurodegenerative diseases.

ClearNote Health has teamed up with researchers at the 英国南安普顿大学 for a large-scale study of pancreatic cancer in patients with type 2 diabetes.

Hologic, Inc. has signed an agreement with the US Centers for Disease Control and Prevention to develop analyte-specific reagents for laboratory-developed tests to detect H5N1 avian influenza.

Bio-Techne has inked a distribution deal with Medsantek to distribute Bio-Techne products in Turkey.

Vevo Therapeutics partners with the Parse Biosciences GigaLab to Generate 100M Cell Atlas for AI Powered Drug Discovery

Tracer Biotechnologies has signed a multiyear agreement with 阿斯利康 to use Tracer's technology for clinical trials.

Mission Bio announced a collaboration with Dr. C. Ola Landgren, MD, PhD, head of one of the world’s leading myeloma computational and translational research laboratories. Dr. Landgren’s team, including Dr. David Coffey and Dr. Benjamin Diamond, at the University of Miami ’s Sylvester Comprehensive Cancer Center will work together to generate clinical data sets using Mission Bio’s Tapestri Single-cell DNA Multiple Myeloma Panel to examine Multiple Myeloma (MM) at an unprecedented level of clonal detail, promising to reveal new insights that may potentially improve outcomes for MM patients.

November

SOPHiA GENETICS has launched MSK-IMPACT powered with Sophia DDM, a version of the tumor comprehensive genomic profiling test developed by Memorial Sloan Kettering Cancer Center that uses the Sophia DDM platform for data analysis.

Complete Genomics has launched an mpox (MPXV) virus amplicon sequencing panel that is based on ATOPlex multiplex PCR technology and covers the full genome of the virus.

GeneDx has launched GeneDx Discover, a data visualization tool that provides biopharmaceutical companies with access to deidentified and aggregated genetic data for drug development.

Reference Medicine has launched characterized specimens, which are research specimens with genomic and biomarker profile information for specific cancer types.

MRC Holland has launched an updated version of its D007 Acute Lymphoblastic Leukemia (ALL) assay.

Takara Bio USA, Inc. has launched the SmartChip Real-Time PCR system, an automated high-throughput qPCR platform for pathogen detection that is for research use only.

10x Genomics and Beckman Coulter Life Sciences have launched an automated single-cell gene expression workflow. It includes an automation-friendly library preparation kit from 10x and a method from Beckman Coulter and is designed to enable higher throughput and reduce hands-on time for single-cell gene expression studies.

Scale Biosciences and Revvity 's BioLegend business have launched TotalSeq Phenocyte single-cell protein profiling, a product for identifying and characterizing rare cell subtypes.

Azenta Life Sciences has launched a long-read whole-genome sequencing test for clinical applications.

Ansa Biotechnologies, Inc. has launched Ansa Clonal DNA synthesis services for products up to 5 kb in length.

CeGaT GmbH has launched an updated version of its ExomeXtra test. Version 6 incorporates noncoding splice sites and noncoding RNAs involved in splicing.

Genomic Testing Cooperative has launched GTC Interpret, a web-based platform designed to provide member laboratories and partner labs with access to a comprehensive range of NGS DNA and RNA data.

Biofidelity has launched Aspyre Lung Reagents for research use only in liquid biopsy samples. Aspyre Lung identifies established non-small cell lung cancer biomarkers in both DNA and RNA from tissue and blood in a four-step workflow and runs on existing qPCR platforms.

Omega Bio-tek has launched Mag-Bind Endo-Free Plasmid Mini & Midi magnetic bead-based kits for purifying endotoxin-free plasmid DNA.

Agena Bioscience has launched the VeriDose Core Panel v2.0 for the detection of 85 variants (SNPs/indels) across 16 pharmacogenetic genes with Tier 1 and Tier 2 recommendations from leading societies for pharmacogenetics analysis.

Parse Biosciences has launched Evercode Low-Input Fixation kits for cells and nuclei. The new kits are designed for researchers who have a small number of starting cells or nuclei who ordinarily might not be able to perform single-cell sequencing using fixed cells.

CS Genetics has launched SimpleCell 3' Gene Expression kits, the company's first commercial offering for single-cell transcriptomics.

Bruker has announced a new technology for its CellScape Precise Spatial Proteomics platform for highly multiplexed immunofluorescence.

Ionpath has launched the MIBIscope 3.0 imaging platform for high-definition spatial proteomics. The upgraded platform includes advancements that enable researchers to map complex cellular interactions within the tissue microenvironment at subcellular resolution, customize imaging conditions, and set up imaging sessions to run continuously.

EVOBYTE Digital Biology has launched ReadStore, a platform for storing, managing, and integrating genomic data.

Nonacus has launched a research-use-only qPCR kit to detect ESR1 mutations.

GeneCentric Therapeutics, Inc. has launched the ExpressCT (Expression Signatures Through Circulating Tumor Signals) liquid biopsy platform, a development tool that adapts RNA-based gene expression signatures to cell-free DNA liquid biopsy assays in order to provide insights beyond DNA mutations.

Natera ’s Prospera lung test receives Medicare coverage for single lung transplant patients

凯杰 ’s QiAcuityDx digital PCR system gets regulatory clearance in Australia and New Zealand. They also get FDA clearance for the QiaStat-Dx panel that can detect meningitis and encephalitis

Foundation Medicine 's FoundationOne’s Liquid CDx assay has received approval from the FDA for use as a companion diagnostic with Merck KGaA's Tepmetko (tepotinib) in patients with non-small cell lung cancer.

Diasorin submits gram-positive bacteria panel for FDA 510(k) clearance

Adaptive Biotechnologies Corp. ’ test receives expanded Medicare coverage for mantle cell lymphoma

Caris Life Sciences ’ MI Cancer Seek NGS-based assay has received FDA approval

New York State DOH approves Biotia 's AI-, sequencing-based urinary tract infection test

December

赛默飞世尔科技 has launched the Applied Biosystems MagMax Sequential DNA/RNA Kit, a magnetic bead-based technology that promises to enable the sequential purification of high-quality genomic DNA and total RNA from a single whole blood or bone marrow sample for cancer research.

PGxAI has launched Sirius, an AI model for personalizing drug selection, dosage adjustment, and drug-drug interaction management based on a patient's genome.

凯杰 has launched Ingenuity Pathway Analysis (IPA) Interpret, a feature leveraging artificial intelligence algorithms and IPA's 50,000 citations in a manually curated knowledge base.

Parse Biosciences has launched its Evercode Mouse B-Cell Receptor kit. The kit enables mouse BCR repertoire profiling alongside whole-transcriptome data for millions of cells, including BCR clonotype diversity and VDJ gene usage frequencies.

Vizgen announced the official launch of its Certified Service Provider (CSP) program. The CSP initiative aims to empower researchers around the world by expanding access to Vizgen’s MERSCOPE? and MERSCOPE Ultra? Platforms for high-quality spatial genomics services through a network of certified academic and commercial services organizations, with the training, expertise and technology infrastructure required to provide full-service Vizgen solutions for breakthrough discoveries.

Asuragen, a Bio-Techne brand has launched its research-use-only ESR1 mutation monitoring assay consisting of the QuantideX qPCR ESR1 exoMutation Kit paired with the ExoLution Plus cfDNA + exoRNA Isolation Kit.

ConcertAI and NeoGenomics Laboratories have launched CTO-H, a joint software-as-a-service solution in hematological malignancies for research analytics, clinical trial design, and clinical trial operational optimization.

Bruker launched the Dimension Nexus? atomic force microscope. Dimension Nexus is the newest addition to the industry-leading Dimension? AFM product line.

Alithea Genomics has launched the Mercurius full-length DRUG-Seq library prep technology, which combines massive sample multiplexing and full transcript coverage in an extraction-free RNA-seq workflow

Delve Bio has launched Delve Detect, a metagenomic test that can detect more than 68,000 pathogens in cerebrospinal fluid.

Quantum-Si has released its Protein Barcoding Kit to enable multiplexed protein screening using peptide barcodes.

LGC Clinical Diagnostics has launched Seraseq Solid Tumor FFPE DNA reference material for assay development, validation, and quality control.

OGT has launched SureSeq CLL + CNV V3 Panel, an updated next-gen sequencing test for chronic lymphocytic leukemia research that offers more expansive coverage of disease-associated genes and enhanced CNV calling, resulting in more comprehensive variant detection.

SOLVD Health has received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) for its San Diego-based laboratory.

罗氏公司 has received CE marking for an updated version of its high-throughput PCR-based Cobas 6800/8800 platform.

altona Diagnostics has received the European Union's IVDR certification for the company's PCR-based tests, and the company plans to launch 14 of its molecular test kits through spring of 2025.

bioMérieux has obtained Special 510(k) clearance from the FDA for a syndromic PCR panel to detect tropical fever pathogens.

Cepheid ’s Tuberculosis Assay Receives WHO Prequalification

Foresight Diagnostics has launched a clinical trial to evaluate the use of its Clarity MRD assay in guiding individual treatment decisions for people with diffuse large B-cell lymphoma (DLBCL).

GeneDx has launched a program that provides pediatric epilepsy patients with access to whole-exome sequencing, in partnership with Biogen, Praxis Precision Medicines, and Stoke Therapeutics.

Medicover Genetics announced that its next-generation sequencing-based TarCET genetic testing kit has received certification under Europe's IVDR.

Devyser ’s noninvasive fetal rhesus D (RHD) screening test has received Class D certification under Europe's IVDR certification.

Pharus Diagnostics announces validation of a laboratory-developed test for early pancreatic cancer detection