Clinical, Medical & Diagnostic Products


Liquid Biopsy CDx Test for Advanced Non-small Cell Lung Cancer Receives FDA Approval


The US Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib).


The Agilent Resolution ctDx FIRST is said to offer NSCLC patients and their oncologists a new minimally invasive blood assay to help decide precision treatment options. This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics. ctDx FIRST has also been approved by the FDA for tumour profiling of the epidermal growth factor receptor (EGFR) gene for use by qualified healthcare professionals in accordance with professional guidelines in oncology patients with NSCLC.


As a professional service, the ctDX FIRST test report includes broad genomic profiling on 109 genes across four types of alterations:


single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions. The ctDx FIRST assay uses novel propriety technology to detect genomic alterations in circulating tumour DNA (ctDNA) from plasma.


“Expanding access to accurate and fast genomic profiling is an essential step to unlocking important medicines for patients in desperate need,” said Kenna Anderes, Mirati’s Vice President of Translational Medicine and Companion Diagnostics. “We appreciate the opportunity to partner with companies like Agilent who are committed to creating more opportunities for ‘decision medicine’ for people living with cancer.”


“We are thrilled to partner with Agilent as they work to create greater access to efficient, effective and minimally-invasive tests to support clinicians with information that is critical to their patient care,” said Alan Sandler, MD, Mirati’s Chief Medical Officer. “At Mirati, we are focused on creating meaningful impacts on the lives of people with cancer. Tests like ctDx FIRST are important to realising our commitment to patients.”


“Commercialising the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC,” said Sam Raha, Agilent’s President of the Diagnostics and Genomics Group. “Agilent values opportunities to partner with Mirati and other pharmaceutical companies in developing clinically relevant NGS-based diagnostics that enhance confidence in targeted cancer therapy.”


More information online: ilmt.co/PL/ABAZ 59456pr@reply-direct.com


Multi-slide Digital Scanner for Clinical Applications


The updated version of the NanoZoomer S60 from Hamamatsu Photonics is an automated system capable of scanning up to 60 glass slides. The NanoZoomer S60v2MD Slide scanner system (C16600-21MDEU) is the latest addition to the NanoZoomer series of whole slide scanners, which support clinical diagnosis.


The latest version not only scans faster compared to the previous model in 40x mode, but it also offers exciting new features. Three cassette slots can be used interchangeably for standard and mega-sized slides and it includes selectable fully automated and semi-automated scanning modes. Customers can still expect the convenience of the operational software to help them create scan profiles and perform quality checks on images. Additionally, the S60v2MD complies with IVDR, making it ideal for clinical customers.


The NanoZoomer series is a family of whole slide scanners that convert glass slides into high-resolution digital data by high-speed scanning. Scanned data can be viewed on a PC monitor by using the dedicated viewer software, including a patented navigation map delivering a viewing environment just as if operating a microscope. The image acquisition software (NZAcquireMD) and the image viewing software (NZViewMD) allow users to easily create, view and perform quality-checks on whole slide images.


Behind the hardware and software, clinical customers will find trained specialists supporting them through the adoption of new workflows. In fact, trainings and technical support are in place to ensure a smooth transition whether it is integrating a new scanner model into your workflow, or changing from manual to digital pathology.


More information online: ilmt.co/PL/a1k5 59531pr@reply-direct.com New CE-IVD NGS Test and Analysis Software for Use in Clinical Labs


Next-generation sequencing (NGS) is quickly becoming the platform of choice for tumour molecular profiling due to its ability to simultaneously report on multiple biomarkers. However, lengthy turnaround times can limit the clinical utility of these results. To meet the need for rapid genomic insights, Thermo Fisher Scientific has launched the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx for use in clinical labs.


Using targeted NGS technology, the Oncomine Dx Express Test delivers clinically relevant tumour mutation profiling in as little as 24 hours to aid healthcare professionals, in accordance with professional guidelines, in therapy management of cancer patients. The qualitative in vitro diagnostic (IVD) test detects deletions, insertions, substitutions and copy number gain present in 42 genes and fusions or splicing variants in 18 genes from DNA and RNA in FFPE tumour tissue samples of solid malignant neoplasms. This assay also detects deletions, insertions, substitutions in 42 genes and fusions or splicing variants in seven genes from cfTNA extracted from plasma samples of non-small cell lung cancer (NSCLC). The assay requires minimal sample input, maximising sample success rates.


The Oncomine Reporter Dx software ensures healthcare providers can quickly assess the genomic test results. The software matches the variant data to relevant evidence including approved therapies, guidelines, clinical trials and peer reviewed literature in a user-friendly and customisable report.


The new NGS assay and genomic reporting software, along with the recently launched Ion Torrent Genexus Dx Integrated Sequencer, offer an automated end-to-end CE-IVD workflow. Operated from a single software interface, the overall process includes less than 20 minutes of hands-on time, delivering results with unprecedented rapid turnaround time. The workflow enables any lab to bring the power of genomic testing in-house, improves access to patients and advances precision oncology for those who stand to benefit most.


More information online: ilmt.co/PL/PxzP 58740pr@reply-direct.com


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