Cell and Gene Therapy Bio-Manufacturing Market to Reach $21.46 Billion by 2030

Tempus AI has received 510(k) clearance from the Food and Drug Administration for two next-generation AI cardiovascular products, Tempus ECG-MR and Tempus ECG-PH. Tempus ECG-MR analyzes standard 12-lead resting electrocardiograms to detect signs associated with undiagnosed moderate or severe mitral regurgitation, while Tempus ECG-PH is an AI-enabled software device that analyzes standard 12-lead ECG data and provides a binary output for signs associated with pulmonary hypertension. The clearances come as the AI-ECG analysis market is expected to grow from $2.01 billion in 2025 to $2.40 billion in 2026, a compound annual growth rate of 19.3%, according to the Business Research report. Among peers, GE HealthCare's Advanced Imaging Solutions segment, which combines the former Imaging and AVS businesses, generated $3.77 billion in revenues in the second quarter of 2026, up 5.0% organically, with segment EBIT margin rising 90 basis points to 13.9%. iRhythm Holdings, whose platform is supported by more than 3 billion hours of curated ECG data and more than 12 million patient reports, expanded work with Desert Oasis Healthcare and signed two commercial agreements through Luum during the second quarter of 2026. Tempus shares have declined 17.7% over the past year, and the stock currently trades at a forward 12-month price-to-sales ratio of 7.30X versus an industry average of 4.82X.

EpiSign Inc. and Geneyx Genomex Ltd. announced a partnership to advance the integration of genomic and epigenomic analysis for rare-disease interpretation. Under the collaboration, EpiSign METRIC becomes available to Geneyx customers, letting laboratories incorporate epigenomic evidence alongside genomic and phenotypic information in an integrated interpretation workflow. EpiSign METRIC automates analysis of disease-associated DNA methylation episignatures across more than 300 EpiSign-associated conditions, while EpiSign METRIC 5-base extends that capability beyond methylation microarrays to methylation data generated by Illumina 5-base, PacBio HiFi and Oxford Nanopore sequencing. Geneyx Chief Executive Officer David Yizhar said the partnership combines Geneyx's genomic and multi-omics analysis platform with EpiSign's expertise in DNA methylation and episignatures, and EpiSign co-founder and Chief Scientific Officer Dr. Bekim Sadikovic said genome sequencing increasingly generates genetic and epigenetic information from the same assay. EpiSign Chief Executive Officer Dan Sinai said generating genomic and epigenomic information together from a single assay can reduce wet-lab testing and data-generation costs and shorten the diagnostic odyssey for patients and families. EpiSign METRIC 5-base is available for research use only.

CellCarta has established a strategic partnership with Waters Corporation to jointly pursue companion diagnostic and next-generation flow cytometry opportunities with pharmaceutical and biotechnology companies. The collaboration will initially emphasize flow cytometry-based programs, aiming to give sponsors a coordinated path from biomarker strategy through clinical development, regulatory submission and global commercialization. Waters will provide underlying technology capabilities including instrumentation, reagents, standardized panels, assay development, software analysis, and where appropriate custom reagent and IVD commercialization, while CellCarta will integrate and deploy assays across its global CDx Lab Network, supporting Phase I-III clinical trial testing, analytical and clinical evidence generation, regulatory and logistics support, and commercial laboratory services. The companies cited existing platform alignment between CellCarta's CAP-accredited laboratory in Jining, China and BD flow cytometry platforms as a practical foundation for global sponsors seeking to include China in future multinational CDx and biomarker programs. Todd Chermak, President of CellCarta, said the partnership offers sponsors a more connected path from biomarker strategy through global clinical development and, where appropriate, commercialization, and that the companies are already engaging pharmaceutical and biotechnology companies on near-term opportunities.

Alliance Foundation Trials and Natera announced the launch of AFT-70 NAVIGATE, a global randomized phase III trial evaluating an MRD-guided treatment strategy for patients with intermediate and high-risk ER-positive/HER2-negative early breast cancer. The trial is sponsored and led by AFT, with collaboration and co-funding from Natera and Genentech, a member of the Roche Group. It pairs giredestrant, Genentech's investigational next-generation oral selective estrogen receptor degrader, with longitudinal Signatera Genome MRD monitoring to identify patients who may benefit from escalation with a CDK4/6 inhibitor. AFT expects to enroll more than 2,000 patients with stage II-III disease at approximately 200 sites across the U.S. and internationally, with the primary endpoint of non-inferiority in 4-year distant recurrence-free survival. Giredestrant was selected based on the phase III lidERA trial, which showed a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard endocrine monotherapy, while Signatera was chosen for its evidence in this setting and its Genome-based technology reporting analytical sensitivity below 1 ppm.

Safe Fertility Group Public Company Limited, or SAFE, has announced a three-to-five-year plan to expand its family care base from 40,000 families to 50,000 families, while driving average revenue growth of 10-15% per year from 2027 onward, after revenue in 2026 is expected to hold steady from the 900 million baht recorded in 2025. Dr. Wiwat Kwangkananurak, Chief Executive Officer, said the growth strategy comes from the Preserve and Prevent markets, as younger generations increasingly turn to egg freezing, sperm freezing, and genetic testing, as well as from expanding the base of international patients, who currently account for 50% of all patients. The company is also broadening its business scope into genetic analysis laboratories under Next Generation Genomic Company Limited, providing reproductive medicine and maternal and child medicine analysis services to leading public and private healthcare providers, as well as obstetrics and gynecology clinics both domestically and overseas. It is also in discussions on cooperation with the National Health Security Office, or NHSO, on a project to screen for fetal chromosomal abnormalities from maternal blood, known as NIPT, with services under the NHSO project expected to begin in 2027. It is also discussing ways to provide intrauterine insemination, or IUI, for holders of universal health coverage rights, or the 30-baht scheme, to broaden access to treatment more comprehensively.