Boston Children’s Hospital, Dana-Farber Cancer Institute, and Broad Clinical Labs have announced a new collaborative clinical research and testing initiative to develop and implement a suite of novel clinical diagnostic and prognostic assays specifically tailored to test for rare pediatric cancers.
The Boston Research in Innovative Genomics for Hematologic and Tumor Sequencing (BrightSeq) initiative builds on prior research that demonstrated the clinical relevance of circulating tumor DNA as a biomarker for pediatric solid tumors.
BrightSeq will develop clinical somatic molecular tests for known and suspected pediatric solid malignancies and sarcomas. They will include CLIA assays for somatic whole exome sequencing of tumor samples, ultra-low-pass whole genome sequencing, custom hybrid capture sequencing of liquid biopsy samples for sensitive tumor fraction estimation, and targeted somatic profiling for key genomic alterations relevant to pediatric cancers.
Boston Children’s will lead clinical variant interpretation and reporting; Broad will build, validate, and operate clinical sequencing and genomic analysis; and Dana-Farber will drive patient and consortia engagement, research cohort analysis, and translational assay innovation.
EARLY LYME DISEASE TEST SHOWS PROMISE
A new serologic test for Lyme disease may streamline diagnosis of patients in the very early stages of the disease, according to a recent study published in the
Journal of Clinical Microbiology.
The assay, developed by Kephera Diagnostics, uses a novel immunoassay principle based on previous findings. These findings show that antibody molecules in human serum, elicited by infection with the bacterium that causes Lyme disease, can simultaneously bind to two related but not identical antigens. This approach allows a combination of sensitivity and specificity in a single test that rivals that of currently approved protocols that require two sequential tests, the study said.
The study shows that the sensitivity of this new single-tier test in patients with erythema migrans — the skin rash that forms early in the disease — was over 90%. That is significantly higher than the sensitivity of either of the two-tier testing methods currently approved by the Food and Drug Administration.
PARTNERSHIP FOCUSES ON LIQUID IN NUCLEIC ACID QUANTIFICATION AND PURIFICATION
Beckman Coulter Life Sciences and Hombrechtikon Systems Engineering recently announced a collaboration to update and miniaturize traditional nucleic acid quantification.
The update will streamline critical processes that rely on automated pipetting embedded as a functional extension of the system’s ecosystem. It also is designed to drive efficiency and precision at scale while eliminating manual intervention and allowing real-time, data-driven decision making within a unified platform.
The collaboration involves a liquid handling process that precisely measures nucleic acid concentration and purity at 260/280 and 260/230 nanometer ratios. The analysis allows immediate recovery or advancement of sample volume through workflow based on user needs by using an instrument that integrates into established workflows and protocols.
The partnership also will simplify fluorometric analysis of nucleic acid quantification so that results for 96 samples can be delivered in as little as 20 minutes, according to the companies.
EXPANDED PARTNERSHIP COVERS HOME COLLECTION FOR COLORECTAL CANCER SCREENING
Exact Sciences recently announced an expanded partnership with Humana to enhance access to colorectal cancer (CRC) screening.
Through the partnership, the Cologuard Plus test was made available as an in-network service for eligible Humana Medicare Advantage members nationwide in August 2025.
Cologuard Plus, which launched in March 2025, has received Food and Drug Administration approval, Medicare coverage, and inclusion in national screening guidelines from the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021), the company noted.
The Cologuard Plus test is a first-line, noninvasive CRC screening option for adults aged 45 or older who are at average risk for the disease. It detects specific DNA markers and blood in stool associated with cancer, and allows patients to complete the collection kit at home without special preparation or time off from work and return it to the lab for results.
INFORMUTA EXPANDS WITH NEW LAB
After opening a new laboratory at the New Orleans BioInnovation Center, Informuta now can conduct pilot validation and clinical studies for its cutting-edge artificial intelligence and DNA sequencing-powered diagnostic platform, the company recently announced.
Informuta, which specializes in sequencing and machine learning-based diagnostics for infectious diseases, said the new lab brings the company’s clinical research operations to New Orleans and highlights how local partnerships with Ochner Health, the Tulane Innovation Institute, and a coalition of investors are shaping the city’s emergence as a biotech hub.
The new facility tests infections to determine drug susceptibility and forecast the likelihood that an infection will evolve to show drug resistance during treatment.
These predictive insights could accelerate treatment decisions, improve patient outcomes, and strengthen antibiotic stewardship efforts, the company leaders said.
NEW JAPANESE INITIATIVE PROMOTES GASTRIC HEALTH
In Japan, a new nationwide public health initiative aims to raise public awareness of and improve gastric cancer screening rates, provide wider access to noninvasive blood-based screening, and reduce strain on hospitals and conventional screening facilities, the RNA technology company Mirxes recently announced.
The initiative, which former Japanese Prime Minister Yukio Hatoyama, Mirxes Japan, and Nagawa Pharmaceutical began, will offer free screening to 10,000 residents across Japan, with a particular focus on senior citizens. It will leverage the Mirxes GASTRO-Clear, a novel noninvasive microRNA-based blood test.
Japan holds a high incidence of gastric cancer, second only to China’s globally. In 1994, gastric cancer screening was incorporated into the National Cancer Screening Program, with endoscopy becoming the preferred method for gastric cancer detection. Despite these initiatives, 2022 data shows that most adults do not get gastric cancer screening.
The launch of this initiative coincides with the launch of a strategic partnership between Mirxes Japan and Nagawa Pharmaceutical that aims to accelerate the development and deployment of Mirxes’ early cancer screening solutions and strengthen its brand recognition across Japan.
Read the full November-December issue of CLN here.
