CLN - Regulatory Roundup

Illumina Unveils Cancer Genomic Profiling Test

Regulatory Roundup: May 2022

Illumina recently received the CE mark for TruSight Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer. According to the company, this test is the first CE-marked IVD kit for comprehensive genetic profiling of cancer based on DNA and RNA content.

TSO Comprehensive (EU) is designed to help inform precision medicine decisions for cancer patients for the purposes of both personal care and clinical trial enrollment. It assesses biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by evaluating both DNA and RNA, as well as complex genomic signatures, such as microsatellite instability and tumor mutational burden. This comprehensive assessment eliminates the need for running separate, sequential gene tests from multiple biopsy procedures. It also provides a turnaround time of 4–5 days from sample collection to clinical report generation.

The test covers a broad range of mutations and current and emerging biomarkers associated with European Society for Medical Oncology guidelines, drug labels, and clinical trials. In contrast, conventional single biomarker tests and targeted hotspot panels are limited in the number of targets they analyze and are more likely to miss critical information, Illumina said.

Smart Home Lab And PCR-Quality SARS-CoV-2 Test Available in Canada

An interim order authorization from Health Canada allows Cue Health to sell and distribute its molecular SARS-CoV-2 test for both professional use at the point of care and consumer self-testing. Cue’s test uses molecular nucleic acid amplification technology to provide results directly to connected mobile devices in 20 minutes. The test can be used on adults and children ages 2 and over, with or without symptoms.

The supervised test meets current SARS-CoV-2 testing entry requirements for international travel in many countries around the world, including Canada and the U.S., and results are also often accepted by employers, schools, and sports and entertainment venues.

The Cue Health Monitoring System (Reader) and Cue’s molecular SARS-CoV-2 at-home test can be accessed through Cue’s eCommerce site and in-app shop.

FoundationOne CDx Recieves FDA Approval for Two New Uses

Foundation Medicine recently announced that its FoundationOne CDx test has received Food and Drug Administration (FDA) approval for two uses. The first is as a companion diagnostic to identify non-small cell lung cancer patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations and might respond to treatment with EGFR tyrosine kinase inhibitors approved by FDA for this indication. The test is also approved to identify patients with microsatellite instability high status solid tumors who may benefit from treatment with Merck’s Keytruda (pembrolizumab). Company officials said the new companion diagnostic approvals underscore an important shift toward tumor-agnostic cancer care that they hope will simplify decisions for oncologists and their patients.

Point-of-Care SARS-CoV-2 Rapid PCR Test Gains FDA EUA

Minute Molecular Diagnostics recently announced Food and Drug Administration emergency use authorization for its rapid DASH SARS-CoV-2/S test.

The PCR test operates on the DASH analyzer, which consolidates the entire PCR testing process on a nasal swab specimen, providing a result in approximately 15 minutes.

According to company officials, DASH provides central laboratory quality SARS-CoV-2 PCR results at the point of care in approximately the same time as an antigen test. Nonlaboratory personnel can insert a nasal swab specimen directly into a test cartridge and then load the cartridge into the DASH instrument. This simple design makes the DASH test suitable for schools, universities, congregate care settings, and workplaces.

Gastrointestinal Infection Molecular Multiplex Panel Gets CE Mark

Luminex recently received the CE mark for its xMAP NxTAG Gastrointestinal Pathogen Panel (GPP).

The new molecular panel is a comprehensive multiplex test that detects nucleic acids from 16 of the most clinically relevant bacterial, viral, and parasitic pathogens in stool samples on the Magpix system. These pathogens include eight types of bacteria (including C. difficile, Salmonella, and Campylobacter), five types of viruses (including norovirus and rotavirus), and three parasites including Giardia lamblia.

The NxTAG GPP test provides same-day results and may reduce antibiotic use and support antibiotic stewardship efforts. The test runs up to 96 samples at a time, delivering higher throughput in a simplified workflow for high-volume testing laboratories. Users can also customize the targets included in the test to meet the needs of their physicians.

Guardant Health Earns Regulatory Approval for Guardant360 CDx In Japan

Guardant Health recently announced that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted regulatory approval of Guardant360 CDx, a liquid biopsy blood test for comprehensive genomic profiling in patients with advanced solid tumors. MHLW also approved Guardant360 CDx as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab).

Previously, in December 2021, MHLW granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer who may benefit from treatment with Lumakras (sotorasib).

Seegene SARS-CoV-2 Test Gets CE Mark

Seegene has received the CE mark for its Allplex SARS-CoV-2 fast MDx assay, which delivers results within 30 minutes and matches the accuracy of RT-PCR tests, according to the company. The test uses an isothermal amplification method that does not require a thermal cycler for the amplification process, thereby reducing the turnaround time. The company hopes the assay, which can detect SARS-CoV-2 in asymptomatic patients, is cost-effective enough to allow widespread access and easy use at airports, schools, and other large-scale facilities.

Laboratories will be able to process the test using Seegene’s fully automated MDx system, AIOS. The combination of the test and automated system will provide a hands-free workflow from extraction to the interpretation of results, increasing access to testing at venues that need fast, accurate, and large-scale testing, according to the company.