The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.
The test is based on RNA sequencing and is used to differentiate between idiopathic pulmonary fibrosis and other lung diseases in order to avoid surgery.
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
The PCR-based Carba assay is designed to detect and differentiate bacterial gene sequences that are associated with resistance to carbapenem antibiotics.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.
The addition of the Y chromosome detection will enable the firm to refine its already-approved MaternalFetalScreen T1 test to provide personalized risk assessment.
The test detects genomic drug resistance mutations in HIV-1 that can lead to treatment failure and is validated on the firm's automated Sentosa workflow.
The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.
The test is designed to identify and differentiate between Zika, dengue, and chikungunya in serum samples, even in the presence of more than one target.
Last year, the Gottlieb-led FDA approved 25 new molecularly-defined drugs and expanded indications compared to 19 in the prior year, and issued a slew of guidelines important for the personalized medicine field.
A new analysis finds that it will be more than a century until female computer scientists publish at the same rate as their male counterparts, ScienceInsider reports.
