Regulatory Approval

U.K. regulators approve "world-first" sickle-cell gene therapy

U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease and transfusion-dependent β-thalassemia. They are the first regulatory body to approve the treatment.

November 20, 2023

FDA plans to increase oversight of LDTs garner strong response

Plans to increase U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs) have drawn a strong response from trade groups, individuals, and organizations.

November 17, 2023

BioMérieux receives CE Mark for biomarker assay for mild TBI

BioMérieux has obtained the CE Mark for its assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).

October 16, 2023

Alzheimer’s drug approval poised to reshape APOE testing market

The U.S. Food and Drug Administration (FDA) approval of Biogen and Eisai’s Alzheimer’s disease drug Leqembi is likely to drive changes in the APOE testing market, according to an article in GenomeWeb.

September 25, 2023

Guardant 360 CDx receives approval in Japan for NSCLC

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for select patients with HER2-mutant NSCLC who are eligible for treatment with the antibody drug conjugate Enhertu.

September 7, 2023

With pilot program, FDA seeks to reduce risks of LDTs that identify cancer biomarkers

The agency said it has become increasingly concerned that some companion diagnostic tests made by laboratories that it has not authorized may not provide accurate and reliable test results.

June 20, 2023

Seegene obtains IVDR certification for 30 diagnostic assays

The newly certified assays include eight for gastrointestinal infections, seven for women's diseases, five for respiratory diseases, four for tuberculosis, three for meningitis, two for human papillomavirus (HPV), and one for drug resistance.

June 1, 2023

FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults

Paxlovid is the fourth drug — and first antiviral pill — approved by the FDA to treat COVID-19 in adults.

May 25, 2023

Beckman Coulter Diagnostics announces global launch of immunoassay analyzer

The analyzer can run up to 215 tests per hour per square meter and, according to Beckman Coulter Diagnostics, beta users attest to a feature that redefines their workday with no daily maintenance requirements.

May 15, 2023

FDA grants de novo request enabling the marketing of QuidelOrtho SARS-CoV-2 antibody tests

The tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 to aid in identifying patients who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.

May 10, 2023

FDA approves first respiratory syncytial virus vaccine

Arexvy is the first respiratory syncytial virus (RSV) vaccine approved for use in the U.S. It is indicated for the prevention of lower respiratory tract disease caused by the virus in individuals 60 years of age and older.

May 3, 2023

Tempus granted FDA premarket approval for colorectal cancer CDx

The NGS test detects substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status.

May 1, 2023

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