NEW YORK – Digital pathology firm Paige said this week that the US Food and Drug Administration has granted breakthrough device designation for its Paige Lymph Node artificial intelligence software for detection of breast cancer metastases in lymph node tissue. The medical device software is used to highlight areas of concern for further review by pathologists. Paige said it trained Paige Lymph Node on more than 32,000 digitized hematoxylin and eosin lymph node slides and, in an investigational study, it detected the presence of metastases with near perfect sensitivity.
New York state is making newborn screening for Duchenne muscular dystrophy mandatory for all babies born in the state, advocacy group Parent Project Muscular Dystrophy said this week. Starting in 2024, all newborns in the state will undergo screening for the inherited disease, and at least 21 infants are expected to be diagnosed with Duchenne. The state's decision was based on a pilot program that ran from 2019 to 2021 and identified four infants with Duchenne or Becker muscular dystrophy. New York is the second state, after Ohio, to make newborn screening for Duchenne mandatory.
EKF Diagnostics Holdings said this week that it opened a 24,000-square-foot life sciences manufacturing site in South Bend, Indiana, to address a market gap for mid-volume manufacturing. The firm is a specialist manufacturer of enzymes and custom diagnostic, pharmaceutical, and industrial products, and it said the plant's modular design lets it provide bioreactor capacities for end-to-end services from benchtop or proof of concept through full-scale commercial production. The facility is operating with full fermentation capabilities and is expected to provide its full menu of downstream processing capabilities by December.
Revvity's board this week declared a regular quarterly dividend of $.07 per share of common stock, payable on Feb. 9, 2024, to all shareholders of record at the close of business on Jan. 19, 2024.
According to a spokesman for Centogene, a joint venture formed with Lifera is expected to close in November. The JV, announced in June, will be based in Saudi Arabia. Centogene is receiving a $30 million convertible loan investment as part of the deal.
Digital pathology firm Proscia announced this week that it has received ISO 27001 certification for compliance with information security management standards. ISO 27001 includes requirements for establishing, implementing, maintaining, and improving an information security management system. Proscia said in a statement that it completed an audit by a third-party firm to verify its compliance.
Nucleix said this week its CE-marked Bladder EpiCheck liquid biopsy test for detection of primary or recurrent bladder cancer is available in France through the firm's participation in the Association Francaise d'Urologie Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer. The registry is evaluating the diagnostic performance of urine biomarkers and comparing them with bladder endoscopy results performed during two years of follow-up testing. The Bladder EpiCheck test, which is used to detect disease-specific changes across 15 methylation markers, is also US Food and Drug Administration 510(k)-cleared for detection of bladder cancer recurrence.
Yale School of Medicine this week announced it will launch the Stephen and Denise Adams Center for Parkinson's Disease Research, in which researchers will work to develop precision diagnostics and treatments for the neurodegenerative disorder. Researchers at the center also plan to create a biobank of data for research and create analytic tools that use genetics and other health data to predict patients' likelihood of developing the disease and what therapeutics might help to prevent debilitating symptoms. The center will bring together scientists and engineers from neurology, neuroscience, cell biology, genetics, bioinformatics, and computer science.
Fapon said this week that it has been granted an exclusive license by Swiss biotech firms Lascco and Abionic for use of the pancreatic stone protein (PSP) biomarker for sepsis diagnosis in China. Fapon will research, develop, manufacture, and commercialize PSP raw materials and chemiluminescent immunoassay-based reagents within China. According to China-based Fapon, the PSP immunoassay received CE marking under the IVDR and Australian registration, and 510(k) clearance from the US Food and Drug Administration is anticipated in 2024.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.