NEW YORK – Siemens Healthineers said this week that its Advia Centaur serum Neurofilament Light Chain test has received breakthrough device designation from the US Food and Drug Administration. The test was developed in collaboration with Novartis and measures NfL in human serum and plasma to identify patients with relapsing multiple sclerosis who are at lower risk versus higher risk of multiple sclerosis disease activity. The assay is intended to be used in conjunction with clinical, imaging, and laboratory findings, the company said.
Cue Health said this week that it has partnered with Albertsons Companies to provide its molecular COVID-19 tests at participating pharmacies across the US. The program was piloted last fall in 40 pharmacies in Washington state and has since been rolled out to 900 pharmacies, with plans to make the tests available at most Albertsons pharmacies in the coming weeks, Cue said. Pharmacy personnel will conduct the tests and results will be delivered to customers via email.
Hologic said this week that it has opened an innovation center in Aix-en-Provence, France, following its 2019 acquisition of SuperSonic Imagine, a medical imaging firm based in the same city. The facility will serve as Hologic’s new French headquarters. It will operate as a hub to bring innovations to market, expanding access to new technologies in the European market and building the expertise of healthcare professionals, Hologic said. At the innovation center, a new commercial office, training, and research and development facility will support Hologic’s ultrasound, interventional, and surgical products across the continuum of breast healthcare.
Theradiag said this week that it recorded a loss of €767,000 ($847,000) for full-year 2021. In a statement, the French diagnostics company said that results in 2021 were affected by "exceptional expenses associated with its COVID" business "that was deployed in an opportunistic manner in 2020." Theradiag had announced it is discontinuing its COVID-19 antigen testing business and has cleared its stock of such products. Expenses associated with the COVID activities were estimated to be €500,000 in 2021. The firm previously said that its 2021 revenues grew 7 percent year over year.
Quotient said this week that the New York Blood Center and Centro de Transfusiones de la Comunidad de Madrid of Spain have joined MosaiQ's Innovator's Circle, a community of experts that represent laboratories from multiple countries focused on transfusion medicine and, soon, other areas of clinical diagnostics. Members of the Innovator's Circle partner with Quotient for innovation and to generate evidence to improve patient care and laboratory efficiencies, the firm said. To date, three European and three US transfusion medicine laboratories, including US-based Blood Assurance, have joined the Innovator's Circle, and more are under evaluation. Quotient said it is launching an investigator-initiated research program open to members of the Innovator's Circle and healthcare professionals seeking to study the clinical and economic impact of the firm's MosaiQ system.
HealthTrackRx this week announced the opening of a new facility in Marietta, Georgia. Called HealthTrackRx of Georgia, the lab will serve the Atlanta area and offer a comprehensive menu of PCR-based infectious disease tests, with results delivered the next morning. The firm said it plans to open additional facilities in key markets throughout the US as part of its efforts to make next-day PCR results the standard of care for chronic and acute infection detection.
NGeneBio said this week that it has applied to Korea's Ministry of Food and Drug Safety for Class III in vitro diagnostic medical device approval of its next-generation sequencing test OncoAccuPanel. NGeneBio developed the panel — which can detect microsatellite instability status, tumor mutational burden, and more than 300 cancer-associated genes — in collaboration with the Seoul Asan Medical Center and the Dana-Farber Cancer Institute. The firm is also preparing the OncoAccuPanel for CE-IVD marking in Europe.
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.