January 16, 2026 | Diagnostics took center stage at the 44th Annual J.P. Morgan Healthcare Conference this week, and even companies not formally presenting at the event timed announcements to highlighting new products and readouts from recent studies.
In addition to the Grail presentation, here are some of the diagnostic talks and news we’ve gathered over the course of the week. –the Editors
Natera: Cancer Detection and Women's Health Testing
Natera announced several developments starting with the company’s acquisition of Foresight Diagnostics, which closed in early December. Foresight's proprietary "phased variant" technology can detect cancer DNA at concentrations as low as one part per 10 million—a tenfold improvement over current standards. Natera plans to integrate this technology along with structural variants into Signatera by mid-2026, creating what CEO Steve Chapman called "a gold-plated MRD [minimal residual disease] test." The acquisition also positions Natera to enter the lymphoma market, including diffuse large B-cell lymphoma and non-Hodgkin's lymphoma—a market of roughly 70,000 new patients annually.
Natera unveiled an AI foundation model that combines digital pathology, genome sequencing, and over one million longitudinal blood sample measurements to enhance cancer recurrence prediction. The company reported statistically significant improvements over DNA-based testing alone and plans to submit findings to ASCO. The enhanced scoring system, expected to launch mid-2026, leverages Natera's partnership with NVIDIA.
In women's health, Natera launched Fetal Focus, a non-invasive prenatal test screening for 21 severe genetic conditions including cystic fibrosis—the largest panel available industry-wide. The test addresses a critical gap when paternal testing isn't feasible, showing 96% sensitivity and 98% specificity in the company's EXPAND trial.
Natera reported strong enrollment in its FDA-enabling FIND study for early colorectal cancer detection, with a current enrollment rate of 20,000 patients and plans to complete 35,000-patient enrollment in 2026, positioning for FDA submission in mid-2027.
GeneDx: Expanding Audience, Growing Dataset
GeneDx outlined an aggressive expansion strategy at the conference, announcing entry into several new markets while reporting strong 2025 performance that included over 30% growth and $427 million in revenue.
The company's most significant 2026 initiative targets general pediatricians following landmark sequencing recommendations issued last June by the American Academy of Pediatrics. These guidelines—the first update in over a decade—direct pediatricians to use whole exome and whole genome sequencing for children with suspected global developmental delay. GeneDx is deploying 50 newly trained sales representatives and introducing "one-minute ordering" workflow technology designed specifically for pediatricians' 15-18 minute patient appointments. The addressable market includes 25,000 pediatricians diagnosing 600,000 patients annually with developmental or intellectual delays. The company expects meaningful adoption to begin in Q4 2026, approximately 18 months after guideline publication.
GeneDx is looking upstream of pediatrics as well. GeneDx reported breakthrough results from its Guardian newborn screening study in New York, where 3.2% of tested babies had clinically actionable genetic conditions that would have otherwise gone undiagnosed for an average of 7-11 years. With 70% parental enrollment rates, the data supports GeneDx's long-term vision of universal genomic newborn screening. Florida's new Sunshine Genetics Act will transition genomic newborn screening from research to clinical practice for the first time.
The company is also launching a prenatal diagnostic genome for late-term pregnancies where fetal abnormalities are suspected—distinct from carrier screening or noninvasive prenatal testing (NIPS). The offering targets maternal-fetal medicine specialists and builds on organic growth the company has observed with its existing exome product.
On the other end of the age spectrum, the company plans to enter adult specialist markets in 2026, initially focusing on adults who should have been diagnosed as children with conditions like epilepsy and autism. Future expansion will target adult cardiology and neurodegenerative diseases including Parkinson's, Alzheimer's, and frontotemporal dementia.
The company's GeneDx Infinity database grew 30% in 2025 alone—more than the previous 24 years combined—now containing over 1 million exomes and genomes from 2.5 million patients. GeneDx claims its database provides diagnoses twice as accurate as competitors. The 2025 acquisition of Fabric Genomics enables international expansion by allowing local sequencing paired with GeneDx's centralized interpretation platform and database access. Building on the database, the company plans to grow its biopharma data business, recently identifying 2,200 re-contactable patients for a pharma partner seeking only hundreds—demonstrating the database's power for accelerating rare disease therapeutic development.
SAGA Diagnostics: MRD for Colorectal Cancer
SAGA Diagnostics launched its ultrasensitive Pathlight MRD diagnostic test for patients with colorectal cancer (CRC). This expands the clinical application of Pathlight following its successful commercial launch in early-stage breast cancer last year. The launch is supported by data from the CITCCA study, one of the largest real-world ctDNA studies in stage I–III CRC, particularly in rectal cancer. Within the larger prospective study conducted in collaboration with investigators from the Karolinska Institutet, Pathlight was used to retrospectively analyze ctDNA from a cohort of 377 patients, of whom approximately 40% had rectal cancer.
Personalis: MRD with Variant Tracker
Personalis announced the early access launch of Real-Time Variant Tracker, a powerful new option added to its ultrasensitive NeXT Personal MRD test. Clinicians using the NeXT Personal MRD test will now be able to opt-in for additional reporting on detected resistance and therapeutically targetable mutations that can inform new opportunities to optimize patient management. This includes ESR1 mutations, which can be an indication to switch therapy for HR+/HER2- breast cancer patients, and hundreds of other clinically relevant mutations for solid tumors.
Labcorp: Whole Exome, Whole Genome MRD
Labcorp is expanding its MRD suite to include Labcorp Plasma Detect ID, a whole exome sequence-guided, personalized panel for patients with stage I–III breast cancer or stage I–IIIA non-small cell lung cancer, and the nationwide availability of Labcorp Plasma Detect Genome, a whole-genome MRD test for stage III colon cancer. Both Labcorp Plasma Detect ID and Labcorp Plasma Detect Genome MRD tests can detect ctDNA down to a limit of detection (LOD95) of 0.005%.