Mayo Clinic and Thermo Fisher launch Precure, LLC
October 2026—Mayo Clinic on Sept. 15 announced the launch of Precure, LLC, with founding partner Thermo Fisher Scientific, to help transform how the life sciences community understands the biological changes that occur as people move from health toward disease.
Mayo Clinic says Precure, LLC will create one of the world’s leading biomedical data sets through one of the largest human multi-omics data-generation efforts, integrating proteomic, genomic, and longitudinal clinical data to help researchers identify early biological signals of disease and provide a foundation for discoveries in disease biology, diagnostics, and therapeutics.
By connecting molecular and clinical data over time, Precure, LLC has the potential to help researchers better understand early disease-related changes, accelerate drug development, and create new opportunities for earlier diagnosis, intervention, and more personalized care across a wide range of diseases.
Precure, LLC will bring together molecular data generated from 1 million biospecimens, linked with longitudinal clinical information collected over several years, integrating genomic and proteomic information with Mayo Clinic’s clinical data and expertise in a highly standardized setting. Advanced AI and large-scale data analytics will be integral to identifying patterns within these complex data sets and translating them into actionable insights.
Mayo Clinic will serve as the majority owner of Precure, LLC. Thermo Fisher joins the partnership as a minority owner.
Together, the organizations contribute complementary expertise designed to generate the molecular and clinical data needed to accelerate discovery and translate new insights into advancements in patient care. Mayo Clinic combines clinical and research leadership with advanced AI and data science capabilities, extensive biospecimens, and longitudinal de-identified clinical data. Thermo Fisher brings its proteomics expertise and solutions, including its Olink Explore HT platform.
Precure, LLC complements Precure Research, Mayo Clinic’s investigator-led scientific effort to understand the biological changes that occur in the progression from health toward disease. Precure Research advances the science of identifying and understanding early disease signals, while Precure, LLC provides the scale, infrastructure, and collaborations needed to generate population-scale molecular data and help translate discoveries into new diagnostics, therapeutics, and other solutions.
RAS inhibitor approved for pancreatic cancer
The Food and Drug Administration on Aug. 26 approved Revolution Medicines’ RAS inhibitor daraxonrasib (Rasonque) for metastatic pancreatic cancer.
The approval is for the treatment of adults with metastatic pancreatic adenocarcinoma who have been treated with at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Cepheid launches RADAR for pathogen surveillance
Cepheid has launched its RADAR platform to provide greater visibility into pathogen surveillance, strain coverage assessment, and diagnostic readiness activities.
RADAR (Routine Analysis of Strain Dynamics and Test Reliability) encompasses proactive strain surveillance activities to identify genetic changes in circulating pathogens that may affect the performance of diagnostic tests. The key pathogens Cepheid is monitoring using RADAR are SARS-CoV-2, influenza, and Clostridioides difficile.
Drone test flight for anti-doping sample transport
Sysmex America is supporting research into the future of anti-doping sample transport after the completion of a 1,000-kilometer drone test flight in Alaska.
The International Testing Agency, in collaboration with Sysmex America and the Alaska Center for Unmanned Aircraft Systems Integration, part of the University of Alaska Fairbanks, assessed whether blood samples can be transported safely and reliably over extended distances while maintaining their integrity.
For its part, Sysmex America equipped a purpose-built satellite laboratory, installed in an airport hangar, with XN-Series technology, in addition to providing financial support.
One group of blood samples from healthy subjects flew aboard the drone; a matched control group remained on the ground. Onboard sensors tracked temperature, pressure, humidity, vibration, and acceleration throughout the flight. Both groups were analyzed post-flight in the same onsite laboratory under identical conditions.
Andy Hay, chairman of the Sysmex America board of directors, said in a news release that what is most exciting for the company is “what it signals beyond sport.”
“The same technology that can move a blood sample across 1,000 kilometers of Alaskan wilderness could one day bring timely diagnostics to patients in the world’s most remote communities,” he said.
The International Testing Agency will submit the findings for publication in a peer-reviewed journal. Results will be communicated once the scientific evaluation is completed.
Leica acquires StatLab
Leica Biosystems on Sept. 28 completed its acquisition of StatLab Medical Products from Linden Capital Partners and Audax Private Equity.
Leica said the acquisition will bolster its end-to-end portfolio, from specimen collection and preparation through advanced staining, digital imaging, and AI-enabled diagnosis. Its aim is to help pathology laboratories achieve more efficient diagnostic workflows.
CAP updates 14 cancer protocols
The CAP released in September revisions to 14 cancer protocols as part of its quarterly update cycle. The revisions incorporate new WHO classifications, precision medicine advances, and changes that affect laboratory accreditation and cancer reporting.
Among the most significant changes: The breast phyllodes tumor protocol is now required for accreditation when reporting malignant phyllodes tumors.
The full summary of revisions is online at https://bit.ly/CAP_CCP.
Amended regulations adopted in NY
New York State’s Department of Health Wadsworth Center on Sept. 2 adopted amendments to the state’s clinical laboratory regulations, including a change in how laboratory leadership qualifications are structured.
Subpart 58-1 of Title 10 of the New York State Codes, Rules and Regulations was amended, and a new subpart 58-6 was adopted.
Under the new framework, subpart 58-1 is amended to update the requirements for the issuance of a clinical laboratory permit and the expectations of the lab director and technical directors, incorporating changes proposed in subpart 58-6.
Subpart 58-6 replaces part 19. The regulation establishes a laboratory director certificate of qualification for those who are physicians or earned doctoral degree holders and hold certification from a board recognized by the federal Health and Human Services agency.
The regulation also establishes a technical director certificate of qualification for those who are physician or earned doctoral degree holders who meet minimum training and/or experience expectations in one or more categories/specialties of testing and may or may not be certified by a recognized board. This certificate will entitle the holder to provide technical oversight of a given category held on the clinical lab permit. The lab director may qualify for both certificate types.
In other amendments is the addition of the histotechnologist title as a recognized clinical lab practitioner in accordance with Education Law and recognition of this title as a qualified supervisor in histopathology.
New board members for Project Santa Fe Foundation
Project Santa Fe Foundation and Clinical Lab 2.0 added three leaders to its board of directors: Mercè Jordà, MD, PhD, MBA, chair of the Department of Pathology and Laboratory Medicine, University of Miami Miller School of Medicine; William G. Morice, MD, PhD, president and CEO of Mayo Collaborative Services/Mayo Clinical Laboratories; and Peter Weir, MD, MPH, chief population health officer, University of Utah Health.
The foundation says each of the new directors brings expertise to advance the movement of transitioning laboratories from reactive confirmation of diagnosis to proactive prediction using risk stratification of data the lab has already.