Roche launches Axelios 1
August 2026—Roche in June launched its Axelios 1, a next-generation single-molecule sequencing platform that it says will address bottlenecks in genomics and potentially in clinical research.
Axelios 1 is powered by proprietary sequencing-by-expansion, or SBX, technology. The platform converts DNA/RNA into high signal-to-noise “Xpandomers,” which are measured by a sequencing instrument using a reusable complementary metal-oxide-semiconductor sensor containing millions of nanopores. This architecture, Roche said in its June 29 announcement, enables accurate, ultra-rapid, flexible, and high-throughput single-molecule sequencing with near real-time analysis.
The Axelios 1 platform can be used for smaller, faster batches or larger projects without changing systems or workflows, and it can produce same-day whole genome results.
Roche will offer library-prep kits and a free open-source bioinformatics analysis suite tailored for the SBX technology. The platform is built to allow for the flexible use of other life sciences tools.
The SBX technology was unveiled in early 2025. Since then, Roche said, multiple research applications have been tested on it as proof of principle, including whole genome sequencing, RNA sequencing, single-cell RNA, and spatial and methylation, among others. Roche said early-access users have also demonstrated practical research applications across oncology, genetics, and infectious diseases.
Axelios 1 is for research use only.
3rd-generation GeneXpert unveiled at ADLM
Cepheid launched at the ADLM meeting last month the third generation of the GeneXpert system.
At product launch, the new system is designed to support Cepheid’s menu of U.S. FDA-cleared tests, and the workflows laboratories rely on, while introducing a fully integrated touchscreen interface, redesigned software, and a more intuitive user experience.
Looking ahead, Cepheid says the system is designed to support a new generation of Xpert tests and applications, including high-plex panel testing, fast time to result, and sample-to-answer solutions that may extend to next-generation sequencing workflows.
The first system to launch will be the compact four-module configuration, which the company said in its July 22 news release is expected to begin shipping to U.S. customers in the coming months. Additional configurations, including higher-capacity GeneXpert systems and GeneXpert Infinity systems, are in development.
Recommendations for providing optimal care to the gender-diverse population
An ADLM document published last month provides guidance on incorporating gender diversity into pathology and laboratory medicine practice (Thomas TT, et al. J Appl Lab Med. 2026;11[4]:887–926).
The authors of the document focus on five topics, one of which is reference intervals and the interpretation of laboratory tests impacted by the use of gender-affirming hormone therapy. The others are considerations related to transfusion medicine and to gender diversity in autopsy and death investigation, interpreting histology from tissues impacted by gender-affirming hormone therapy and surgical procedures, and informatics challenges and opportunities.
To address the need for published recommendations in the U.S. that broadly cover laboratory medicine, anatomic pathology, and pathology informatics, an expert panel was convened to review the literature as it relates to clinical laboratory and regulatory frameworks.
Each of the five sections the authors cover contains questions and answers and summary statements. Here is a sampling of the summary statements from the laboratory tests and informatics sections:
- While gender-affirming hormone therapy significantly impacts basal levels of high-sensitivity cardiac troponin, the clinical significance of this for risk assessment of AMI or future cardiovascular events is unclear.
- Gender-affirming hormone therapy does not impact interpretation of laboratory tests related to heart failure.
- There is currently no consensus on whether SAAB—the classification of an individual as male, female, or intersex based on physical characteristics observed at birth—or gender identity is more appropriate to be used as the sex variable when calculating eGFR with modern eGFR equations.
- A holistic approach involving additional laboratory monitoring (cystatin C, eGFRcr-cys, uACR) is important for kidney risk assessment for people receiving gender-affirming hormone therapy.
- The authors add this alternative approach, if informatics capabilities permit: Calculate eGFR using creatinine with both sexes and dual report (e.g. eGFR female, eGFR male) on separate lines for clinicians to observe gender-affirming hormone-therapy–related changes and to allow flagging of abnormal eGFR regardless of sex.
- For laboratory tests with sex-specific reference intervals, the common laboratory practice is to use legal sex (recorded on a person’s official documents) from the EHR/LIS to assign reference intervals. Clinical laboratories and clinicians should be aware that some transgender patients will have changed their legal sex in the EHR, thus influencing which reference interval will display.
The full document is at doi.org/10.1093/jalm/jfag071.
Pathology residents now at UConn School of Medicine
The last time the Department of Pathology and Laboratory Medicine at the UConn School of Medicine had a pathology residency program was in about 1994. Now, decades later, it does so again: In July, it began training two residents in its newly established and accredited program.
Two residents will be accepted each year into the four-year AP/CP program, led by program director Gahie Nam, MD, assistant professor of pathology and laboratory medicine and medical director of surgical pathology and histology.
The two residents in the program this year are Sonam Talreja, MBBS, and Gabriel Pastrana, MD.
Leica to acquire StatLab
Leica Biosystems, an operating company of Danaher, has entered into a definitive agreement to acquire privately held StatLab Medical Products, a global developer and manufacturer of anatomic pathology products, from Linden Capital Partners and Audax Private Equity. Following the closing, StatLab will become part of Leica Biosystems.
StatLab provides a broad portfolio of products across the preanalytical and analytical histology workflow, from specimen collection and tissue processing through slide preparation and staining. Built on a strong reputation for quality, innovation, and customer partnership, StatLab shares Leica Biosystems’ commitment to advancing cancer diagnostics and improving outcomes for patients worldwide.
The transaction is expected to close by the end of this year and is subject to customary conditions, including receipt of applicable regulatory clearances. Financial terms of the acquisition were not disclosed.