C. auris Diagnostic Submitted for FDA Breakthrough Device Designation
T2 Biosystems Inc. has submitted an application with the FDA for Breakthrough Device Designation for the company’s Candida auris test.
T2 Biosystems Inc. has submitted an application with the FDA for Breakthrough Device Designation for the company’s Candida auris test.
A team of researchers in Tokyo, Japan, has developed a rapid, efficient assay system for validating ECHS1 variants.
An advanced DNA sequencing technique, or molecular autopsy, was able to determine why a young child died after a relatively mild infection, when a traditional autopsy could not.
Most current molecular tests have been developed as laboratory-developed tests, outside the strict regulatory framework of the FDA.
Read MorePathogenDx expanded the reach of its patented multiplexed molecular testing technology, Dynamic Dimensional Detection (D3 Array).
Read MoreCentogene launched an enhanced next-generation sequencing (NGS)-based assay, for rare and neurodegenerative diseases.
Read MoreA new method of measuring tRNA in blood samples offers a simple and highly-precise alternative to invasive diagnostic and prognostic methods.
Read MorePCR Biosystems launched a new proofreading polymerase mix for NGS library preparation workflows: the VeriFi Library Amplification Mix.
Read MoreA new study informed use of PARP inhibitors beyond BRCA1/2-deficient tumors and reevaluated biomarkers for PARP inhibition in prostate cancer.
Read MoreBio-Rad Laboratories launched two new thermal cyclers, designed to optimize PCR applications such as sequencing, cloning, and genotyping.
Read MoreSeegene declared the commencement of sharing its syndromic PCR technologies all over the world in an effort to prevent future pandemics.
Read MoreEIT Health’s innovation project, EDIT-B, has developed a blood diagnostic test designed to differentiate bipolar disorder from depression.
Read MoreResearchers successfully sequenced four people’s genomes and tracked the mutations in each of them, along with their genetic consequences.
Read MoreTo create the new assay, Acutis Diagnostics will pair SOPHiA DDM for Hereditary Cancers Solution with their laboratory analysis technologies.
Read MorePlanned Parenthood Mar Monte (PPMM) has teamed with BD to provide STI testing for the most common infections to underserved populations.
Read MorePharyngitis testing and diagnosis can be improved by utilizing existing molecular testing capacity increased due to COVID.
Read MorePatients with chronic myeloid leukemia need regular BCR::ABL1 testing for the rest of their lives, which can translate into more lab work.
Read MoreThough not a new diagnostic technique, multiplex testing is poised to become the standard of diagnostic care in the post-pandemic world.
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