Labcorp Launches First FDA-Approved PTEN Companion Diagnostic for Prostate Cancer

Roche Diagnostics has provided two molecular testing instruments to the Institut National de Santé Publique to support Ebola testing capacity in the Democratic Republic of Congo, where an outbreak caused by Bundibugyo virus has pushed demand for testing beyond current laboratory capacity. Roche will preconfigure the Light cycler and Magna Pure instruments and train local laboratory technicians before deploying the equipment to Bunia for validation testing. The Institut National de Santé Publique will conduct local validation of the Bundibugyo virus, after which Roche anticipates further tests could be shipped and additional instruments deployed. The delivery follows Roche's June announcement that it had developed a Research Use Only molecular PCR test targeting Bundibugyo virus. As of 28 September 2026, UN Health Authority data reported 8,067 confirmed cases and 3,901 deaths, a case fatality rate of 48.4% across 60 health zones in six provinces, and the WHO has assessed the risk in the DRC as very high and confirmed the outbreak remains a public health emergency of international concern.

NeoGenomics, Inc. issued preliminary third-quarter 2026 revenue guidance of about US$209 million with very strong next-generation sequencing growth and outlined plans to increase its full-year revenue guidance. The company also amended its bylaws to expand its Board to up to eleven directors. In a planned leadership transition, President and COO Warren Stone will become CEO and join the Board in January 2027, while current CEO Tony Zook moves to Executive Chair and the Board refreshes its independent leadership. The stronger revenue outlook, particularly in NGS, supports the near-term revenue catalyst but does not materially change the central risk that high fixed costs and heavy investment could weigh on margins if volumes soften or funding pressures persist. NeoGenomics' narrative projects $997.4 million revenue and $64.1 million earnings by 2029, with a $19.72 fair value estimate.

Oku Digital Health, Inc. announced its global launch from Topcon Healthcare, Inc., unveiling an AI-powered digital health company that turns routine eye exams into a front door for early disease detection and accelerated clinical development. The company operationalizes its Healthcare from the Eye approach across a connected network of more than 10,000 care locations, built on Topcon's global installed base of 50,000+ diagnostic devices, and says it has screened over 2.2 million patients outside of traditional eye care. Oku combines AI-supported diagnostics, EHR integration, and referral workflows to connect healthcare providers in primary care, optometry, ophthalmology, and specialties with pharmaceutical partners seeking patient data and real-world evidence for drug development and precision medicine. Ali Tafreshi, who remains Chief Strategy Officer for Topcon Corp.'s Eyecare Business Division and Chief Executive Officer of Topcon Healthcare Inc., leads Oku as Chief Executive Officer, joined by Chief Operating Officer Trent Norris, Chief Data AI Officer Matthew Lungren, Chief Medical Officer Daniela Ferrara, and Chief Strategy and Business Development Officer Jacques Gilbert. The company is built on Microsoft Azure cloud infrastructure and optimized for AI workloads with NVIDIA CUDA libraries, and will make its debut at the American Academy of Ophthalmology Annual Meeting in New Orleans from October 9 to 12, 2026, within the Topcon Healthcare booth at AAO 1737.

Telix Pharmaceuticals announced that the first patients in the United States have been dosed with Pixclara, its FDA-approved amino acid PET imaging drug for glioma, marking the start of U.S. commercial availability. The doses were administered at the Indiana University Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center in Cleveland, with Telix's U.S. manufacturing and pharmacy distribution partner PharmaLogic Holdings Corp. supplying finished unit doses to the U.S. market. Pixclara, also known as floretyrosine F 18 or 18F-FET, is the only FDA-approved radiopharmaceutical imaging drug for glioma and is indicated to help differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients one month of age and older. Gliomas account for approximately 30% of all brain and central nervous system tumors and 80% of all malignant brain tumors, with roughly 24,000 new glioma cases diagnosed in the U.S. each year. Telix said Pixclara is also the subject of a Phase 3 registrational study for potential indication expansion into the diagnosis of brain metastases.