The US Food and Drug Administration (FDA) has issued a 510(k) clearance to Versant Medical Physics and Radiation Safety’s Qdose multi-purpose voxel dosimetry software.
Qdose software is used to assess the amount of absorbed radiation to organs and tissues from medically administered radiopharmaceuticals. The software provides estimates of organ absorbed dose and effective dose, which can be used to measure dosages of radiopharmaceuticals.
Qdose was developed by Germany-based contract research organisation (CRO) ABX-CRO in collaboration with Sweden-based Quantinm AB. Versant is the exclusive vendor of the Qdose software in the North American region.
Dr Darrell Fisher, a nuclear medicine physicist at Versant, said: “Qdose simplifies dosimetry by integrating steps from image data import to processing, analysis, and reporting. The software supports a variety of workflows, including planar (2D), hybrid (2.5D), and volumetric (3D) dosimetry, and a specialised module for yttrium-90 selective internal radiation therapy (SIRT).”
Qdose, along with IDAC-Dose2.1, is compliant with the medical internal radiation dose (MIRD) schema, stylised models, and processes set forth by the International Commission on Radiological Protection (ICRP). The software has received clearance from both the FDA and the European CE mark, certifying its use for both diagnostic and therapeutic radiopharmaceutical dosimetry.
Radiopharmaceuticals are radioisotopes bound to tumour-seeking antibodies, strung together by a special ‘linker’ molecule. There has been an increased interest in radiopharmaceuticals in recent years.
In October 2023, Eli Lilly agreed to acquire a radiopharmaceutical company POINT Biopharma for $1.4bn. POINT’s pipeline consisted of radioligand cancer therapies in the clinical and preclinical development stages. Last month, POINT announced positive Phase III trial data (NCT04647526) for its lead radioligand therapy, 177Lu-PNT2002. The therapy is being evaluated in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed on androgen receptor pathway inhibitors (ARPI).
In November 2023, Telix Pharmaceuticals signed a conditional non-binding term sheet to acquire QSAM Biosciences in a deal worth up to $125m.
The use of software for determining dosing has been used in other instances. Irish biotechnology company Shire has a web-based pharmacokinetic (PK) dosing software for haemophilia A patients aged 16 years and above who weigh a minimum of 45kg and have been treated with recombinant anti-haemophilic factor (Recombinant) called myPKFiT. The software received 510(k) clearance by the US FDA in 2017.
