CLN - Regulatory Roundup

Blood Test Helps Predict Progression to Cirrhosis

Regulatory Roundup: November 2021

The Food and Drug Administration has granted marketing authorization to the Siemens Healthineers Enhanced Liver Fibrosis (ELF) test. When announcing the authorization, Siemens Healthineers said that the blood test is the first prognostic tool for patients with advanced fibrosis due to nonalcoholic steatohepatitis to receive de novo marketing authorization. Used with the Advia Centaur XP Immunoassay system, the test provides a simple numeric score automatically generated by an algorithm. The score assesses likelihood of progression to cirrhosis and liver-related clinical events. High-risk patients identified by the ELF test may benefit from additional examinations, increased monitoring, and lifestyle changes and treatment interventions.

Traditionally, identifying high-risk patients has involved liver biopsy to spot scarring of the liver. In contrast, the ELF test measures biomarkers directly involved in the active process of scarring. The test combines three serum biomarkers to assess the likelihood of progression to cirrhosis and liver-related clinical events. The biomarkers are hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of matrix metalloproteinase 1.

Affordable COVID-19 Saliva Test Gets FDA Emergency Use Authorization

The Food and Drug Administration has granted emergency use authorization to a saliva-based laboratory diagnostic test for SARS-CoV-2. Developed

at the Yale School of Public Health, SalivaDirect is now available to other diagnostic laboratories and has been validated with reagents and instruments from multiple vendors. This flexibility is intended to enable continued testing if some vendors encounter supply chain issues, as occurred early in the pandemic.

According to test developers, the test is simple and uses inexpensive reagents. They added that their goal was to develop an assay useful for widespread testing to control the COVID-19 pandemic. To that end, the test does not require preservatives or specialized tubes for saliva collection. The researchers expect that labs could offer the test for about $10 per sample.

Yale is now working to validate this method as a test for asymptomatic individuals through a testing program for players and staff in the National Basketball Association. 

FDA Approves BD Automated High-Throughput Molecular Diagnostic Platform

The BD Cor PX/GX system has received Food and Drug Administration (FDA) approval. The system integrates robotics and sample management software algorithms to automate the complete molecular laboratory workflow from sample processing to diagnostic test results. It received the CE mark in Europe in 2019.

The BD Cor system is modular and scalable, and designed to address multiple needs within laboratories for expanding molecular testing and increasing test volumes. It has onboard capacity for reagents and samples that provide 6 to 8 hours of unimpeded system processing, thus eliminating multiple technologist interactions currently required per shift.

Now that this platform is FDA-approved, the BD Onclarity HPV assay with extended genotyping for the BD Cor system will be available to the high-throughput labs that process most cervical cancer screening specimens in the U.S.

Sexual Health PCR Test Uses Patient-Collected Samples

Visby Medical has received Food and Drug Administration 510(k) clearance to market its fast, single-use polymerase chain reaction (PCR) test for the multiplexed detection of sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The test also received a CLIA waiver, enabling any healthcare site with a CLIA Certificate of Waiver to perform it during a patient’s appointment.

According to Visby Medical, the test—known as the Visby Medical Sexual Health Click test—is the first for these STIs that uses PCR technology in a handheld, instrument-free format. It uses a self-collected vaginal swab and provides results within 30 minutes. By making STI check-ups more convenient for patients, Visby said it hopes that the test will help to reduce growing STI rates, especially in communities with limited access to testing during the COVID-19 pandemic.

FDA Approves Co-diagnostic for Previously Treated IDH1-Mutated Cholangiocarcinoma

The Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target test for use as a companion diagnostic (CDx). Under the approval, the test can be used to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA) who may be candidates for Servier Pharmaceuticals’ Tibsovo (ivosidenib tablets). CCA is a rare, aggressive cancer of the bile ducts within and outside of the liver. IDH1 mutations occur in up to 2% of U.S. CCA cases. 

The Oncomine Dx Target test uses next-generation sequencing and first earned FDA approval in 2017. In addition to being approved for use with Tibsovo, it was previously approved for four targeted therapies for non-small cell lung cancer.

Tibsovo is an IDH1 inhibitor approved for adults with previously treated, locally advanced, or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test.

At-Home Collection Kits Get CE Mark

Zymo Research’s new line of at-home sample collection kits has received CE marking for sale in the European Union. The SafeCollect Sample Collection kits are designed for consumers to self-collect both swab and saliva samples. Zymo Research scientists and engineers developed SafeCollect in response to scrutiny of the growing number of drive-through SARS-CoV-2 test sites that require consumers to collect their own samples.

The kits feature an at-home collection device that is specially engineered to enable consistent sampling, and that also includes user safety features. Tubes have a safety seal that prevents accidental spillage, contact, and/or ingestion of the sample stabilization medium. Devices are filled with Zymo Research’s proprietary stabilization solution that preserves DNA and RNA at ambient temperature for at least 30 days. This solution was the first 510(k)-cleared transport medium for collection, preservation, and inactivation for SARS-CoV-2 and provides an additional layer of protection for those who come into direct contact with samples, including couriers and laboratory personnel.