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M&A

?? Roche to acquire LumiraDx Point-of-Care Testing Tech for up to $350M

♀? Hera Biotech Acquires Endometriosis Dx Assets from Scailyte and Raises $15M in Series A Round

??Veracyte Acquires C2i Genomics for up to $95M

???Aditxt (a subsidiary of Pearsanta) acquires MDNA Life Sciences’ cancer testing platform for over $25M

???Parse Biosciences acquires RNA-seq data-analysis firm Biomage

??Myriad Genetics to acquire select assays from Intermountain Precision Genomics

??Natera acquires reproductive health assets from Invitae for up to $52.5M

??Numa Biosciences merges BioSystics and Nortis. Numa is the first company to combine advanced organ-on-chip technology with the power of data-driven analytics.

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Legal

??Personal Genomics' 2019 patent infringement suit against Pacific Biosciences is set to resume after both parties lost appeals that had been keeping the case on hold.

??Geneoscopy challenges Exact Sciences patent through inter partes review petition

??Jury awards Ravgen $57M in NIPT patent suit against Natera

??Jury awards Natera $96.2M in damages in patent infringement case against CareDx

????Congress introduces bill to prevent medical providers from using BGI, MGI and affiliates' products

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Layoffs and Restructuring

??Cue Health Lays off 94 People as FDA Declines to Grant COVID/Flu Test EUA

??NanoString Technologies is laying off 9 Percent of its workforce and received a Nasdaq delisting notice

??Blockchain Genomics firm LunaDNA to shut down

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Collaborations

??CN Bio & Altis Biosystems partner to development in-vitro model for ADME studies

??MaxCyte has signed a new strategic platform license with Imugene Limited

??Akoya Biosciences has entered into a license and distribution agreement with Thermo Fisher Scientific for spatial biology systems and reagents.

??Evosep & Thermo Fisher Scientific strike comarketing deal for clinical proteomics offerings

???Deepcell partners with Nvidia to incorporate generative AI into Single-Cell Analysis

??Complete Genomics & Gencove ink comarketing agreement for low-pass whole-genome sequencing

??Vector Laboratories & Navinci Diagnostics partner to develop biomarker discovery tools

??Quantum-Si inks deal with Tomy?Digital Biology to distribute platinum protein sequencing instruments in Japan

??Becton Dickinson & Hamilton ink collaboration to automate single-cell Multiomics

??AtlasXomics & EpiCypher partner to commercialize spatial epigenomics assays

??Metabolon partnering with Sheffield Institute on ALS research

??Personalis to distribute ClearNote Health's epigenomic cancer detection tech

??Oxford Nanopore Technologies & Lonza to develop mRNA quality control test

??Olink & Formulatrix collaborate on automated proteomic workflows

??Quest Diagnostics & Ultima Genomics team up to develop clinical sequencing tests

??Illumina has had multiple collaborations including with Janssen (liquid biopsy test), Devyser Diagnostics (IVD) and Ginkgo Bioworks (comarketing agreement for biosecurity)

??Sekisui Diagnostics & Aptitude Medical Systems sign US distribution deal for POC COVID test

??Allogene Therapeutics & Foresight Diagnostics partner to develop MRD Test for CAR T-Cell Therapy Trial

???Caris Life Sciences & Flatiron Health team up on Oncology real-world database

???Predicine & Janssen to collaborate on bladder cancer CDx assay

??AbbVie partners with ConcertAI & Caris Life Sciences to advance precision oncology drug development

??DNAnexus strikes a deal with Intelliseq (genomic data analysis), Ovation (Omics Data-Management & Analysis) and TMA Precision Health (rare disease research)

??Optithera, ELNA Medical Group & Génome Québec Partner on saliva-based type 2 diabetes test

??BostonGene & Prisma Health partner to study molecular, immune profiles of rare tumours

??MilliporeSigma licenses CRISPR IP to Huntington's Disease Research Nonprofit

??Centogene & Michael J. Fox Foundation to study genetic risk factors of Parkinson’s disease

??Flagship Biosciences & Offspring Biosciences form assay development services alliance

??Biofidelity & Fidelis partner to supply ASPYRE-lung test to VA medical centres

??GSK & Elegen ink collaboration and licensing agreement for synthetic DNA

??Centogene & Institut Imagine team up on Multiomic Research for Rare Disease Drug Discovery

???Seegene & Microsoft collaborate to support MDX development

??Qiagen & Penn State form strategic alliance for microbiome research and training

??Agilent & Incyte ink companion diagnostic development pact for haematology & oncology

??Invitae & BridgeBio Pharma partner on rare disease drug discovery

??Wellcome Sanger & Stellenbosch University collaborate for global infectious disease surveillance

QuidelOrtho

CEO Doug Bryant highlighted the successful merger of Quidel and Ortho Clinical Diagnostics, focusing on leveraging their global footprint, cross-selling opportunities, and playing a significant role in the molecular diagnostic space. The recently FDA-cleared Savanna instrument is expected to drive growth. Bryant emphasized the importance of capital allocation, focusing on R&D, debt reduction, share repurchases, and potential M&A deals to accelerate growth and market share.

NanoString Technologies

CEO Brad Gray, aims for spatial biology market penetration and cash flow breakeven in 2024 post-legal setbacks. Despite a recent patent lawsuit loss and injunction in Europe, the focus remains on growth in spatial biology platforms GeoMx and CosMx. Upcoming launches include the CosMx Human 6K Discovery Panel and CosMx Human Whole Transcriptome Panel. Gray emphasizes multiplexing improvements for spatial biology and renews commitment to the nCounter gene expression platform.

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Sophia Genetics

CEO & Cofounder Jurgi Camblong and CFO & COO Ross Muken anticipate profitability within two years, with strong growth in cancer analysis. Preliminary 2023 financial results show revenue growth exceeding 30%. Analysis volume highlights include a 362% surge in liquid biopsy volumes. The launch of the MSK-ACCESS clinical test is expected in early 2024. The Sophia DDM platform for ovarian cancer detection saw a 180% increase in analysis volume in 2023.

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10x Genomics

Have revealed the Visium HD system, enhancing resolution for single-cell analyses. The platform initially offers whole-transcriptome measurements and plans for future protein measurements. CEO Serge Saxonov also announced upgrades to Chromium and Xenium platforms, focusing on sensitivity, throughput, and cost reduction.

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Bruker

President and CEO, Frank Laukien, reiterated the company's commitment to the "post-genomic" era, emphasizing investments in proteomics, multiomics, spatial, and single-cell biology. Laukien anticipates rapid growth in these emerging areas, asserting that proteomics and related fields will be equally important as genomic medicine.

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Exact Sciences

CEO Kevin Conroy highlighted the growth potential of Cologuard, aiming for approximately 14 million tests performed annually, assuming a 40 percent market share. The company also anticipates reducing false positives with the next-generation version of Cologuard, which completed its FDA submission and is expected to gain approval by early 2025.

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Qiagen

Have outlined its 2024 growth strategy, focusing on initiatives such as expanding its liquid biopsy portfolio, launching the QuantiFeron Lyme disease test in the US, introducing new tests in the QIAstat-Dx portfolio, and launching QIAcuity Dx digital PCR products for clinical applications in the US and Europe. CEO Thierry Bernard emphasized the company's decision to increase investment in its QDI bioinformatics business organically after unsuccessful discussions about partnering with outside firms.

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NeoGenomics ?

Despite a preliminary injunction restricting sales of its Radar MRD assay, NeoGenomics plans to proceed with MolDx submissions and appealed the ruling. CEO Chris Smith emphasized the company's commitment to MRD testing, considering it a significant opportunity in a roughly $20 billion market with low penetration.

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Veracyte

CEO Marc Stapley explained that the acquisition of C2i Genomics allows Veracyte to enter the MRD testing market, expanding its role across the cancer care continuum. The company believes C2i's whole-genome tumour sequencing platform is a strong fit for its portfolio, offering benefits like small sample requirements and rapid generation of patient-specific signatures.

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Guardant Health

co-CEO Helmy Eltoukhy highlighted the significance of the Guardant360 test as the primary driver of volume growth, with 173k clinical tests performed in 2023. The company anticipates an increase in the test's average sales price (ASP) by about $200 in Q1 2024 compared to Q3 2023, and it is set to launch an updated version of Guardant360 using its "smart liquid biopsy" platform, providing additional insights into tumour phenotypic information and new features based on clinically validated biomarkers.

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Thermo Fisher

President and CEO Marc Casper discussed the company's $3.1 billion acquisition of Olink, describing it as a "phenomenal complementary fit" to their mass spectrometry and life science solutions. Casper expressed optimism for 2024, projecting 1% growth, and emphasized the strong customer adoption of Thermo Fisher's high-end offerings, particularly highlighting the success of its Orbitrap Astral mass spectrometer in a challenging environment.

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Illumina

CEO Jacob Thaysen emphasized the company's goal to resolve Grail's status by the end of Q2 2024. He mentioned the continued adoption of Illumina's NovaSeq X system and the company's expectation to place fewer NovaSeq X instruments in 2024, mainly due to a backlog and challenging macroeconomic conditions.

Thaysen also discussed the evolving focus in the sequencing business, emphasizing Illumina's position with investments in reducing overall workflow costs and enhancing ease of use.

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Oxford Nanopore

CEO Gordon Sanghera revealed the company's three-year plan to drive clinical products, aiming to be ready for revenue-generating opportunities around 2026. He highlighted the importance of improved accuracy with Q20+ sequencing chemistry for clinical applications, acknowledging the need to win the confidence of existing Illumina customers and emphasizing their focus on enabling Multiomic analyses in the long term.

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Natera

CEO Steve Chapman highlighted Natera's strong revenue growth from the Signatera MRD test and discussed efforts to improve reimbursement. He mentioned upcoming catalysts like ALTAIR trial results, potential Prospera test coverage, and Panorama's innovation for 22q11.2 deletion syndrome. Chapman also noted the expected 2024 readout for Natera's early cancer detection test and emphasized the company's successful patent infringement victories as a testament to its intellectual property strength.

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Agilent

CEO Mike McMullen discussed the company's expectations for 2024 as a "transitory" year of recovery with lower growth than the long-term average, citing signs of stabilization in instrument demand and revenues from China. He highlighted Agilent's focus on cancer testing and therapy development in diagnostics, increased investment in the Cell Analysis Division, and a reorganization to align teams and workflows for better customer service while anticipating a return to growth in revenues from China likely in 2025.

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Abbott

CEO Robert Ford highlighted the success of the company's core base business as it transitioned from the impact of the pandemic, expecting continued momentum in 2024 and faster growth than pre-pandemic levels. Ford emphasized Abbott's global presence, with over half of revenue coming from outside the US, and discussed the company's M&A strategy, focusing on diagnostics and medical devices, remaining selective and strategic in potential deals.

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Revvity

CEO Prahlad Singh discussed the impact of the 2023 market downturn in China, highlighting mid-single-digit revenue growth due to a differentiated portfolio in diagnostics and life sciences. Despite challenges, Singh emphasized growth in autoimmune diagnostics and the company's focus on innovation from recent acquisitions in 2024. He expressed confidence in market recovery, with preliminary revenues exceeding expectations, particularly in pharmaceutical and biotechnology markets.

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Adaptive Biotechnologies

CEO Chad Robins plans to decide on reorganizing MRD and immune medicine businesses by Q1 2024. 2024 priorities include growing MRD business volume, expanding into new indications, achieving profitability by H2 2025, and entering clinical trials for T-cell receptor-based therapy with Roche's Genentech. The company is also exploring drug targets for autoimmune disorders.

Danaher

CEO Rainer Blair announced that the company had a better-than-anticipated Q4 2023, with base business core revenues declining in the mid-single digits but all segments performing modestly above expectations. Blair emphasized the positive impact of Cepheid's respiratory testing revenue, exceeding $600 million, and highlighted the sustained success of the four-in-one respiratory virus, estimating that 70% of respiratory testing revenues came from this test, contributing to Cepheid's continued market share growth and success in platform consolidation at the point of care.

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Hologic

CEO Stephen MacMillan highlighted the positive impact of the COVID-19 pandemic on the company's business, emphasizing the substantial increase in Panther instrument placements globally, which has nearly doubled the installed base since 2019 to around 3,260 instruments. The growth in placements, particularly post-pandemic, has driven revenue beyond COVID-19 testing, with MacMillan focusing on expanding the range of assays on the installed base, and Hologic CFO Karleen Oberton noted the stickiness of Panther placements, revealing that more than 90 percent since April 2020 are running at least one other assay besides COVID-19.

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Pacific Biosciences

CEO Christian Henry expects PacBio's Revio sequencer sales to grow in 2024, driven by a strong order backlog after shipping a record 173 sequencers in 2023. The new short-read sequencer, Onso, launched in 2023, is accurate and targeted for oncology. Upcoming launches include high-throughput DNA prep and native DNA kits for Revio. PacBio is developing benchtop HiFi and high-throughput HiFi systems, along with a high-throughput short-read sequencer, aiming to cover both long and short-read markets.

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Grail

CEO Bob Ragusa announced impressive full-year 2023 revenues of $93 million, a 68% YoY increase, and Q4 2023 brought in $30 million. Grail conducted 150,000 Galleri tests with 9,000 providers. Ragusa highlighted growth drivers, including the UK NHS Galleri trial, aiming for 1 million tests by 2024. Grail's Pathfinder 2 study enrolled 25,000 participants, and the REACH/Galleri-Medicare study aims to compare 50,000 beneficiaries. Ragusa emphasized Grail's broader applications beyond multi-cancer early detection and made no comments on Illumina's planned divestment.

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Seer

CEO Omid Farokhzad expects academic publications on Seer's Proteograph to drive sales, but CFO David Horn maintains a conservative 2024 outlook due to uncertainties. Seer's technology played a crucial role in 2023's advancements, and the Seer Technology Access Center launch in June saw positive engagement. Seer's growth hinges on data publication demonstrating technology utility, with upcoming preprints, including early lung cancer detection by PrognomiQ, expected this year.

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Myriad Genetics

CEO Paul Diaz's leads Myriad's successful turnaround, reporting Q4 revenue exceeding estimates at $196-$197 million. Diaz is confident in growth across all product lines, particularly in pharmacogenomics and the oncology franchise. The company plans to launch Precise Liquid and Precise MRD monitoring tests in H2 2025, expanding the women's health business with Prequel and Foresight tests. Strong growth in prenatal business is expected, with launches for new assays in the pipeline.

Quanterix

CEO Masoud Toloue announced Quanterix's completion of a reorganization, reducing cash burn, with a projected Q4 revenue of $30 million, up 16% YoY. The focus remains on neurology, with ongoing trials for the LucentAD p-Tau 217 assay and plans for dried blood spot samples. Quanterix is investing in a next-gen platform for improved sensitivity, multiplexing, and throughput.

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Ginkgo Bioworks

CEO Jason Kelly reported a "breakout year" in the pharmaceutical market, with revenues from pharma and biotech customers growing over 50% YoY, accounting for 36% of active cell engineering programs as of Q3 2023. Preliminary financial results for 2023 estimate revenues in the range of $250 million to $260 million, in line with guidance, citing key deals with Pfizer, Boehringer Ingelheim, and Merck, and recent collaborations with Biogen in 2024.

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Bio-Techne

Incoming CEO Kim Kelderman, mentioned a short-term strategy continuity but emphasized an internal review due to the macroeconomic downturn. CFO Jim Hippel discussed a challenging fiscal Q2, citing softness in biotech funding and conservatism among pharma customers, but noted high demand for the company's products. Kelderman outlined pipeline plans, including a spatial biology assay and developments in liquid biopsy and molecular diagnostics, expressing confidence in facing competition following major acquisitions in the market. M&A remains a priority for Bio-Techne.