Genetic Testing

FDA takes actions to ensure the safety, effectiveness of LDTs

May 1, 2024 - Earlier this week, on April 29, 2024, the United States FDA issued a press release announcing its actions toward ensuring the safety and effectiveness of laboratory developed tests (LDTs). According to the administration, LDTs are considered in vitro diagnostic products (IVDs) for clinical use. These tests are designed, manufactured, and used...


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National Cancer Institute Launches Precision Medicine Initiative

by Veronica Salib

On June 1, 2023, the National Cancer Institute (NCI), a subset of the NIH, launched ComboMATCH, a precision medicine initiative for cancer patients. ComboMATCH — short for Combination Therapy...

Michigan Blue Launches Pharmacogenomics Precision Medicine Program

by Alivia Kaylor

Blue Care Network recently announced the launch of Michigan’s first end-to-end pharmacogenomics precision medicine program, Blue Cross Personalized Medicine. This program leverages genetic...

UC Berkeley Loses CRISPR Gene-Editing Patent Appeal

by Samantha McGrail

The US Patent and Trademark Office (PTAB) recently ruled that CRISPR gene-editing technology belongs to the Broad Institute of Harvard and MIT, according to multiple news sources. After an...

Thermo Fisher Introduces Protein To Advance CRISPR Gene Editing

by Samantha McGrail

Thermo Fisher Scientific recently introduced its new protein, Invitrogen TrueCut HiFi Cas9 Protein, to complement its growing CRISPR gene editing solutions portfolio. CRISPR technology has become...

Pfizer, AbbVie, Biogen Launch Resource for Genetic Variants

by Samantha McGrail

Pfizer, AbbVie, and Biogen recently launched the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease.  The genetic exome sequence...

HHS to Share Best Practices for Point-of-Care COVID-19 Testing

by Samantha McGrail

HHS and The Rockefeller Foundation recently signed an agreement to identify and share effective approaches for increasing rapid point-of-care (POC) COVID-19 testing in various communities.  Under...

FDA Grants EUA for Becton Dickinson’s Rapid COVID-19 Antigen Test

by Samantha McGrail

FDA recently issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antigen diagnostic test that can be used at the point of care. For more coronavirus updates, visit our resource page,...

FDA Grants Emergency Use Authorization for COVID-19 Serology Test

by Samantha McGrail

FDA recently issued an Emergency Use Authorization (EUA) for Abbott’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.  For more coronavirus updates, visit...

Lawmakers Uncover Significant Gaps in COVID-19 Antibody Testing

by Samantha McGrail

The Subcommittee on Economic and Consumer Policy recently released a staff memo with preliminary findings that showed significant gaps in the Trump Administration’s handling of serological...

First Gene Therapy Clinical Trial to Address Genetic Blindness

by Samantha McGrail

Oregon Health & Science University (OHSU) held the first-ever gene therapy clinical trial, BRILLIANCE, to address blindness-causing gene mutation, LCA10, according to a recent press release The...