FDA allows for first POC chlamydia, gonorrhea test
June 2021—The Food and Drug Administration on March 30 allowed the use of the Binx Health IO CT/NG assay in physician offices, community-based clinics, urgent care settings, outpatient health care facilities, and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.
Binx Health applied for a CLIA waiver by application based on data demonstrating the test meets the criteria for a CLIA waiver. This followed clearance for use by individuals trained in the test procedure and under the oversight of a CLIA-certified laboratory that meets the requirements for high- or moderate-complexity testing.
The test, which uses female vaginal swabs and male urine specimens, can detect the presence of Chlamydia trachomatis and Neisseria gonorrhoeae and provide a result in about 30 minutes.
Beckman Coulter launches DxA 5000 Fit
Beckman Coulter in early May launched its DxA 5000 Fit, a workflow automation solution designed to fit into midsize laboratories that run fewer than 5,000 tests a day.
The DxA 5000 Fit offers comprehensive workflow automation to reduce up to 80 percent of manual steps through preanalytical, analytical, and postanalytical automation. It also offers intelligent routing with dynamically calculated route planning for rapid and consistent turnaround time, with stats prioritized to deliver results faster, and flexible design that can be adapted to meet a mid-volume lab’s space and infrastructure constraints.
FDA approves ThinPrep Genesis processor
The Food and Drug Administration granted premarket approval for Hologic’s ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications. The new instrument streamlines these workflows with advanced automation capabilities including chain-of-custody verification. It’s the latest addition to Hologic’s suite of cytology instruments.
PerkinElmer to acquire Immunodiagnostic Systems
PerkinElmer and Immunodiagnostic Systems Holdings PLC reached an agreement on the terms of a recommended all cash offer whereby PerkinElmer will acquire IDS for about $155 million. The transaction is expected to close early in the third quarter of this year.
Through this acquisition, PerkinElmer says it will be able to grow its overall diagnostics business and specifically its immunodiagnostics segment. Moreover, it says, the deal will enable it to combine its channel expertise and testing capabilities with Immunodiagnostic Systems’ chemiluminescence products in endocrinology, autoimmunity, and infectious diseases.
Latest on COVID-19
Editor’s note: See captodayonline.com for news on SARS-CoV-2 tests (Coronavirus News). A list of FDA EUAs for COVID-19 can be found at https://j.mp/covid-19-EUA.