CLN - Regulatory Roundup

Foundation Medicine Lung Cancer Test Gets Two FDA Approvals

Regulatory Roundup: April 2023

The Food and Drug Administration (FDA) recently approved Foundation Medicine’s FoundationOne Liquid CDx to identify types of non-small cell lung cancers (NSCLCs) that could be treated with certain targeted therapies. FoundationOne Liquid CDx is a qualitative next-generation sequencing test. It uses targeted, high-throughput, hybridization-based capture technology to analyze 324 genes in circulating cell-free DNA that has been isolated from the plasma of advanced cancer patients.

Specifically, FDA has approved the test as a companion diagnostic to identify patients with ROS1-positive NSCLC or NTRK fusion-positive solid tumors who do not have a tissue sample available and who may respond to treatment with Rozlytrek (entrectinib), a targeted therapy developed by Genentech. According to Foundation Medicine, FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib).

FDA also has approved FoundationOne Liquid CDx as a companion diagnostic to identify NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and who are candidates for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by FDA for this indication.

FDA CLEARS SELUX NGP SYSTEM FOR RAPID ANTIBIOTIC SUSCEPTIBILITY TESTING

Selux Diagnostics has received Food and Drug Administration (FDA) clearance for its Next-Generation Phenotyping (NGP) system—a rapid antibiotic susceptibility testing platform—and for an antimicrobial resistance test designed to run on this system. According to Selux, the NGP system provides targeted therapeutic results days faster than the current standard of care.

The test cleared to run on the NGP system determines a bacteria's susceptibility to 14 specific antimicrobial agents on the Selux Gram-Positive panel. Selux’s NGP Gram-Negative panel is also currently under review by FDA.

BD, CERTEST BIOTEC EARN EMERGENCY USE AUTHORIZATION FOR MONKEYPOX TEST

The Food and Drug Administration has granted Becton, Dickinson and Company (BD) and Spain-based CerTest Biotec emergency use authorization for a PCR monkeypox virus test. The Viasure Monkeypox Virus PCR Detection assay and Viasure Monkeypox Virus Real Time PCR reagents are now available for users of the BD Max system. The assay is offered in a lyophilized format and comes in a tube designed to work easily with the BD Max ExK TNA extraction strip. As for the BD Max system, it is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR, providing results for up to 24 samples across multiple syndromes in less than 3 hours. The system features a broad menu of tests that also cover healthcare-associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women’s health.

FDA GIVES EUA TO VISBY MEDICAL FOR RESPIRATORY HEALTH TEST

Visby Medical recently received Food and Drug Administration emergency use authorization for its Respiratory Health point-of-care test. This rapid PCR test detects and differentiates between upper respiratory infections caused by influenza A and B, and SARS-CoV-2. The device fits in the palm of the hand and provides results in under 30 minutes.

Both the Centers for Disease Control and Prevention and the Infectious Diseases Society of America recommend that clinicians use rapid molecular flu tests in outpatients instead of rapid antigen diagnostic tests in order to improve detection. However, PCR testing has not been widely adopted in outpatient settings in part because of the expense required to acquire and maintain PCR instrumentation. Visby designed its instrument-free Respiratory Health test with the aim of helping to solve this problem.

DIACARTA GETS FDA OK FOR MONKEYPOX TEST

The Food and Drug Administration has given DiaCarta emergency use authorization for its QuantiVirus MPXV, a PCR test for the qualitative detection of DNA from monkeypox virus. Using lesion swabs collected from individuals with suspected monkeypox infection, the test targets two different regions of the monkeypox virus genome, which are both less prone to mutations than other parts of the genome. This dual-target approach is designed to help QuantiVirus MPXV detect the virus if a mutation occurs in one of the target regions.

The test is designed for use on common quantitative PCR instruments, including the Thermo Fisher (ABI) QuantStudio5, Thermo Fisher (ABI) 7500 Fast Dx, Bio-Rad CFX384, and Roche LightCycler 480 II systems.

FDA CLEARS ACT GENOMICS’ COMPREHENSIVE SOLID TUMOR GENOMIC PROFILING TEST

Prenetics Global has announced that the Food and Drug Administration (FDA) has cleared ACTOnco, a comprehensive genomic profiling test for solid tumors developed by ACT Genomics, a company in which Prenetics has a majority stake. According to Prenetics, this makes ACT Genomics the first Asia-based company to receive FDA clearance for such a test.

ACTOnco helps inform clinical management decisions in accordance with professional guidelines for cancer patients with solid tumors. The test provides comprehensive genomic profiling of 440 cancer-associated genes and helps guide clinical management decisions about targeted oncology therapies, including immunotherapies. The test may be used for many cancers including breast, colon, endometrial, and lung cancer. It is also cleared for use by biopharma companies developing precision therapeutics.

SCOPE MOLECULAR LABORATORY EARNS FDA EUA FOR SARS-COV-2 TEST

The Food and Drug Administration has granted emergency use authorization (EUA) for Scope Molecular Laboratory's SARS nCoV-2019 Multiplexed assay for serial SARS-CoV-2 testing. This PCR test detects SARS-CoV-2 RNA in anterior nasal swab specimens collected by healthcare providers or self-collected under the supervision of a healthcare provider.

Scope Molecular received an umbrella EUA for serial testing, which allows authorized tests to be used with individual or pooled specimens to test people at least once per week regardless of symptoms or exposure to COVID-19. These conditions include serial testing programs in schools or workplaces.

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