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8 Frequently Asked Questions About Genetic Testing in Clinical Trials

Worldwide Clinical Trials

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Why should you use a centralized genetic testing provider for a clinical trial?

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FDA grants approval for bluebird’s Zynteglo to treat beta-thalassemia

Pharmaceutical Technology

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 0 genotypes.

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New Strain of Bird Flu in Nevada Reveals a Concerning Mutation

AuroBlog - Aurous Healthcare Clinical Trials blog

The viral variant, called genotype D1.1, (Dusty Pixel photography/Getty Images) An emerging strain of highly pathogenic avian influenza has spilled over from wild birds to dairy cows in the state of Nevada, and officials at the US Department of Agriculture (USDA) and some scientists are concerned by a mutation they are seeing.

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To Share or Not to Share Failed Genetic Screening Results with Patients

Worldwide Clinical Trials

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. Read the full article!

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US FDA approves Vertex’s Orkambi for cystic fibrosis in children

Pharmaceutical Technology

The treatment is indicated for CF patients who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

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Large-Scale Study Shows Guardant360 Liquid Biopsy Accelerates Clinical Trial Enrollment Compared to Tissue Biopsy

BioTech 365

Nature Medicine Publication Reports that Liquid Biopsy More Than Doubles Clinical Trial Enrollment Rate Compared to Tissue Biopsy REDWOOD CITY, Calif.–(BUSINESS Despite advances in precision oncology, progress is slowed by the limitations of tissue genotyping, … Continue reading → Nasdaq: GH).

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The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans

Worldwide Clinical Trials

The analysis of circulating tumor DNA (ctDNA) in a liquid biopsy can also permit genotyping and help monitor the effectiveness of chemotherapy. The post The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans appeared first on Worldwide Clinical Trials.

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