An early user of a new Mycoplasma genitalium and antibiotic resistance test from SpeeDx that uses the Xpert cartridge shared some initial validation data.
The genetic disease risk test, which covers 59 genes endorsed by ACMG, is offered through the Helix marketplace and includes genetic counseling services.
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.
Individuals identified as needing homozygous FH evaluation will receive confirmatory genetic testing from Invitae and genetic counseling from Genome Medical.
The PCR-based Carba assay is designed to detect and differentiate bacterial gene sequences that are associated with resistance to carbapenem antibiotics.
The biological activity sensors in development consist of nanoparticles conjugated with a peptide substrate produce fluorescence in urine associated with immunotherapy response.
The company filed its first suit against Natera in March, claiming the firm's kidney transplant test infringes patents underlying CareDx's AlloSure test.
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.
As of July 1, the Guardant360 test will be considered medically necessary for aiding therapy selection in advanced lung cancer for health plan members of EviCore.
