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Genetics

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A researcher studies a sequencing flow cell under cold white light, steel instrument housings reflecting a teal laboratory palette.
Genetics

Who Protects Your Genomic Data? GINA, NIH Policy and the Gaps

Genomic data privacy in the United States rests on a patchwork: the Genetic Information Nondiscrimination Act of 2008 bars the use of genetic information in health insurance and employment decisions, while NIH policy governs federally funded research data. Between them sit large uncovered areas…

A gloved researcher pipettes samples into a 96-well plate under cool white lab lighting, brushed-steel bench, teal tones, no readable labels.
Genetics

Genetic Testing Oversight After the LDT Rule Reversal: What Changed

Genetic testing oversight in the United States has returned to its pre-2024 framework: on September 19, 2025, the FDA reverted 21 CFR 809.3(a) to its prior text, after a federal district court vacated the 2024 laboratory-developed-test rule on March 31, 2025, per the FDA’s policy page. Oversight…

A scientist steadies a precision injector over a specimen dish at a steel lab bench in cold teal light.
Genetics

GenEditBio Wins FDA IND Clearance for GEB-101 in TGFBI Corneal Dystrophy

The FDA has cleared GenEditBio's investigational new drug application for GEB-101, an in vivo genome-editing therapy for TGFBI corneal dystrophy, the company announced on January 5, 2026. The clearance enables the Phase 1/2 CLARITY trial, in which participants receive a single intrastromal…

A technician's gloved hands lifting a plate of bacterial colonies from an incubator, condensation on plastic, cool teal laboratory lighting.
Genetics

Gene Synthesis Technology Explained: From Oligos to Screened Genomes

Gene synthesis is the industrial process of building specified DNA sequences base by base, without a natural template. Short fragments are made by phosphoramidite chemistry, assembled into genes enzymatically, and error-corrected before sequencing verification, and in the United States…