Leo O'Connor

Business Insights
Week in Review: Labcorp liquid biopsy | Deep sequencing | Heart disease markers and diabetes
Labcorp has launched a liquid biopsy test to enable targeted therapy selection for patients with advanced or metastatic solid tumors.
June 1, 2023
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Policy and Regulation
Advocacy groups in letter urge FDA to develop regulations for lab-developed tests
The FDA should use its authority to develop laboratory-developed test regulations if Congress does not pass legislation requiring it, said the Center for Science in the Public Interest and other organizations.
June 1, 2023
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Business Insights
Illumina CEO remains on the board, chairman is voted out
Activist investor Carl Icahn, in a proxy fight, had urged the shareholders to remove the chairman and CEO from the board.
May 26, 2023
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Business Insights
Week in Review: Long COVID’s symptoms | Protection against Omicron | Reducing non-respiratory symptom risk
Working with the NIH RECOVER Initiative, researchers at Mass General Brigham have defined signature symptoms of long COVID in a prospective cohort study.
May 25, 2023
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Molecular Diagnostics
Domus Diagnostics gets $2.4M NIH grant to develop at-home molecular test
The award, granted as part of the NIH Rapid Acceleration of Diagnostics (RADx) Tech program, will support accelerated validation and scaling of a testing platform to prepare it for a clinical trial.
May 24, 2023
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Financial Results
Agilent Technologies fiscal Q2 revenues rise 7%; firm trims full-year estimates
Diagnostics and Genomics Group revenues were $362 million, up 1% year-over-year compared to $358 million.
May 24, 2023
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Immunoassays
Beckman Coulter analyzer developed 'from the ground up' to address IVD industry constraints
At a time of scarce resources, the system requires no daily maintenance and only 10 minutes weekly and monthly maintenance, said Dr. Pamela Christudoss of Christian Medical College, who evaluated the analyzer prior to its broad launch last week.
May 23, 2023
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510(k)
Hologic obtains FDA clearance for multiplex SARS-CoV-2/Flu A/Flu B/RSV assay
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours.
May 19, 2023
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Business Insights
Week in Review: Quest on detecting dementia | Roche routine mass-spec test | A Labcorp acquisition
Roche Diagnostics will showcase technologies for lab automation, the serum work area, and molecular and point-of-care solutions at an industry event; it is also unveiling a prototype for the Cobas Mass Spec system.
May 18, 2023
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Business Insights
Week in Review: Public Health Emergency ends | BioMĂ©rieux nabs FDA CLIA waiver | QuidelOrtho granted de novo request
The FDA this past week continued to grant regulatory approvals for tests associated with COVID-19 that lay outside the scope of the emergency use authorization pathway.
May 11, 2023
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Top Stories
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Vascular Disease
Potential drug target to prevent small vessel disease identified in study
Scientists say lab-grown small blood vessels used in new disease models point to a theoretical potential treatment for a major cause of stroke and vascular dementia.
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Trends and Finance
Candel Therapeutics to lay off 50% of workforce, refocus on advanced oncology immunotherapies
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Rheumatoid Arthritis
Scipher Medicine, Quest Diagnostics collaborate on RA diagnostics
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Sequencing
Nanopore sequencing slashes tumor analysis times and costs
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Coronary Artery Disease
AI-powered blood test supports risk stratification of heart disease patients
More in Home
Nanopore Technologies, Day Zero Diagnostics to collaborate on sepsis diagnostic solution
Oxford, U.K.-based Oxford Nanopore Technologies and Boston-based infectious disease diagnostics firm Day Zero Diagnostics have announced a partnership to develop an end-to-end solution for the diagnosis of bloodstream infections.
November 20, 2023
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10x Genomics awarded $31M in patent infringement lawsuit against NanoString Technologies
10x Genomics has been awarded more than $31 million in damages by a jury in the U.S. District Court for the District of Delaware in its patent infringement lawsuit against NanoString Technologies.
November 20, 2023
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Exact Sciences files patent infringement lawsuit against Geneoscopy
Exact Sciences has filed a patent infringement lawsuit against Geneoscopy alleging that Geneoscopy’s recently launched colorectal screening test infringes on a patented method used in Exact Science’s Cologuard assay.
November 17, 2023
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Verici DX, Thermo Fisher Scientific sign licensing agreement on pre-transplant prognostic test
Transplant diagnostic firm Verici DX and Thermo Fisher Scientific have signed an exclusive global licensing and commercialization agreement to develop a pre-transplant prognostic test for early kidney rejection risk assessment.
November 17, 2023
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FDA plans to increase oversight of LDTs garner strong response
Plans to increase U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs) have drawn a strong response from trade groups, individuals, and organizations.
November 17, 2023
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Cytovale raises $84M in series C funding
Medical technology firm Cytovale has raised $84 million in a series C financing round that the firm says it will use to expand the commercialization of its 10-minute IntelliSep test.
November 16, 2023
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Zymo Research, Ad Astra Diagnostics receive FDA 510(k) clearances
Molecular diagnostics firm Zymo Research and rapid diagnostics developer Ad Astra Diagnostics have both received 510(k) clearances from the U.S. Food and Drug Administration.
November 16, 2023
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Networks of wearable sensors capture body sounds to improve patient monitoring
Researchers have developed soft, miniaturized wearable devices to continuously capture the sounds of breathing and other bodily functions.
November 16, 2023
A health care worker places the wearable devices across a patient's chest to capture sounds throughout the lungs that are associated with breathing. Photo courtesy of Northwestern University.
AnchorDx, DiaCarta to collaborate on cancer diagnostics
Biotech company AnchorDx has entered into a long-term partnership with molecular diagnostics firm DiaCarta to develop and commercialize cancer diagnostic products for the global market.
November 14, 2023
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Talis Biomedical to lay off 90% of workforce, pursue strategic alternatives
POC testing company Talis Biomedical has announced that it will lay off 90% of its employees and has begun exploring strategic alternatives.
November 15, 2023
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AI model shows promise detecting COVID-19 in low-resource settings
An artificial intelligence (AI) model shows promise for diagnosing COVID-19 in low-resource settings with severe shortages of medical experts, including in many African regions, according to a study published November 11 in Scientific Reports.
November 14, 2023
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Jury finds Guardant Health liable for $83.4M in patent infringement lawsuit
A jury in the U.S. District Court for the District of Delaware found that Guardant Health infringed on patents held by TwinStrand Biosciences and licensed to the University of Washington.
November 15, 2023
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