Geneseeq scores FDA breakthrough designation for cancer detection devicea

Original from: Medical Device Network

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq.

CanScan was built using Geneseeq’s highly sensitive MERCURY multi-omics technology. The solution uses low-depth whole-genome sequencing (WGS) on circulating cell-free DNA (cfDNA) present in peripheral blood to detect cancer. The genetic and fragmentomic features of the cfDNA are used to detect early cancer signals with 99% specificity and predict the tissue of origin of cancers.

The test can be used to detect a variety of cancer types and can obviate the need for multiple tests, as per a 3 January press release. According to Geneseeq, CanScan has the potential to improve current screening methods in common cancer types such as prostate and lung cancers, as well as detect cancers, which do not have effective detection tools, such as oesophageal and endometrial cancers.

The Canada-based company is validating the CanScan system in a real-world setting as part of the Jinling Cohort clinical trial (NCT06011694). The trial, which is sponsored by Nanjing Shihejiyin Technology, will assess the performance and clinical utility of the MERCURY multi-omics technology test in an average-risk Chinese population. The prospective observational trial aims to enrol 15,000 adults aged 15-75 years.

The primary goal of the trial is to evaluate the sensitivity, specificity, positive or negative predictive value, and other performance of the MERCURY test. The trial will also evaluate how many cancer types can the MERCURY test detect along with the origin accuracy of the tissue.

The introduction of new technologies has led to rapid advances in cancer detection devices. Artificial intelligence (AI) has increasingly been used to aid in cancer detection. AI is particularly useful in analysing medical imaging such as X-rays, CT, and MRI scans to detect cancers.

In November 2023, GE HealthCare launched the MyBreastAI suite, which is a platform of AI apps to help with breast cancer detection and workflows. This added to the company’s existing portfolio of AI-assisted diagnostic systems, including the FDA-cleared Critical Care Suite 2.1, which aids in pneumothorax detection and diagnosis.

In October 2023, Geneseeq Technology’s non-small cell lung cancer tumour mutational burden test (NSCLC TMB) kit was approved by the Chinese National Medical Products Administration (NMPA) as a breakthrough medical device.

Source: Geneseeq scores FDA breakthrough designation for cancer detection devicea