Ortho launches Vitros XT 3400 Chemistry System
April 2020—Ortho Clinical Diagnostics in February made available its Vitros XT 3400 Chemistry System.
The new system, like the Vitros XT 7600 Integrated System, simultaneously performs two tests frequently ordered together on one Vitros XT MicroSlide. Double assay processing offers a 25 percent faster turnaround time on a common panel of assays, Ortho said in its Feb. 26 statement, with an average processing time of 7.5 minutes. The XT MicroSlide allows for a sample volume of 2.7 μL.
Ortho said the Vitros XT 3400 completes its suite of Vitros XT Solutions.
In other news, Ortho Clinical Diagnostics announced in March two FDA clearances, one of its Vitros Brahms PCT assay, which will be available on the Vitros 3600 Immunodiagnostic System, Vitros 5600 and Vitros XT 7600 Integrated Systems, and Vitros ECi/ECiQ Systems.
The other is for its Ortho Sera ID-MTS, a suite of extended antigen in a gel testing format used for blood phenotyping for patients in need of transfusion. It is cleared to run on Ortho Vision and Vision Max in the United States and Canada. The clearances allow testing for more than 99 percent of the most commonly tested blood group antigens to be performed on one platform.
The FDA cleared the suite for use on the Vision analyzer in October 2019 and for use on the Vision Max in January.
The 13 Ortho Sera reagents available in the U.S. and Canada on Vision and Vision Max are anti-D (DVI), anti-D (IAT), anti-Fya, anti-Fyb, anti-Jka, anti-Jkb, anti-K, anti-Lea, anti-Leb, anti-N, anti-P1, anti-S, and anti-s.
FDA approves CINtec Plus Cytology test
The FDA approved Roche’s CINtec Plus Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for HPV using the Cobas 4800 HPV test.
The new test identifies women whose HPV infections are most likely to be associated with cervical pre-cancers. It runs on the Benchmark Ultra IHC/ISH system. The dual-stain biomarker technology detects the simultaneous presence within a single cell of p16 and Ki-67. The test can be performed using the same liquid sample used for HPV or Pap cytology testing.
The FDA considered data from the Roche-sponsored registrational IMPACT (Improving Primary Screening and Colposcopy Triage) trial, which enrolled more than 35,000 women in the U.S. to clinically validate CINtec Plus Cytology as a triage test in different screening scenarios. Publication of study data is pending.
CINtec Plus Cytology is expected to be widely commercially available in the U.S. later this year.
Latest on COVID-19 tests
See captodayonline.com for up-to-the-minute news on COVID-19 tests. A comprehensive list of FDA emergency use authorizations can be found at https://j.mp/fda-eua.