Daily Newsletter

08 August 2023

Daily Newsletter

08 August 2023

Qiagen’s PDGFRA kit gets approval as companion diagnostic to AYVAKIT

The real-time qualitative PCR in vitro diagnostic assay can identify the D842V somatic mutation in the PDGFRA gene.

RanjithKumar Dharma August 08 2023

Qiagen has received approval from the US Food and Drug Administration (FDA) for its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit) as a companion diagnostic to Blueprint Medicines’ AYVAKIT (avapritinib) in gastrointestinal stromal tumours (GIST).

The companion diagnostic will assist clinicians in identifying patients with GIST who could potentially receive treatment with AYVAKIT.

AYVAKIT received approval in the US to treat adults with unresectable or metastatic GIST that carries a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

Qiagen and Blueprint worked together to develop the PDGFRA assay, which is said to be the first to secure FDA approval as a companion diagnostic.

The real-time qualitative PCR in vitro diagnostic assay can identify the D842V somatic mutation in the PDGFRA gene for determining the patients eligible for AYVAKIT treatment.

It utilises genomic DNA extracted from the formalin-fixed paraffin-embedded (FFPE) tumour tissue of a patient.

The QIAamp DSP DNA FFPE Tissue Kit is used to process FFPE tumour specimens, while the Rotor-Gene Q (RGQ) MDx instrument can help in DNA amplification and mutation detection.

Qiagen Translational Science and Precision Diagnostics head and vice-president Jonathan Arnold said: “The therascreen PDGFRA kit is an FDA-approved and validated test, delivering results in a fast turnaround time.

“This ensures that physicians receive results promptly, enabling them to make informed treatment decisions for their GIST patients in a timely and effective manner.”

Healthcare companies are hesitant to invest in the metaverse

The COVID-19 pandemic pushed the healthcare industry to rapid digitalization. Increased use of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology is changing how healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment of psychological and neurological disorders. In the pharma and medical devices industries, AR, VR, and AI are rapidly accelerating drug discovery and manufacturing and generating supply chain efficiencies. New digital opportunities will look to build upon disruptive technologies. However, affordability is a limiting factor to widespread adoption. Per GlobalData estimates, the metaverse market is expected to grow at a CAGR of more than 33% between 2023 and 2030. Although metaverse technologies could reinvent healthcare approaches and bring new experiences to healthcare providers and patients, adoption is still at an early stage. There are currently few use cases in the healthcare industry. The metaverse needs to overcome major challenges for healthcare, including regulation and data privacy concerns. Evidence of proven use cases and participation by a critical mass of users are imperative to drive a shift in metaverse investment.

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