CLN - Regulatory Roundup

FDA Continues to Look for New Ways to Advance SARS-CoV-2 Testing

Regulatory Roundup: September 2020

As the Food and Drug Administration (FDA) continues efforts to improve SARS-CoV-2 testing in the U.S., the agency has announced its participation in the COVID-19 Diagnostics Evidence Accelerator. This multi-stakeholder collaborative project—organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research—aims to drive the development of SARS-CoV-2 diagnostics. Like its companion project, the COVID-19 Therapeutics Evidence Accelerator, this initiative will harness real-world data to inform FDA’s overall response to the COVID-19 pandemic. Key issues that the project will examine include the real-world performance of SARS-CoV-2 diagnostic tests and antibody tests, how to best tailor testing strategies to specific populations, and what test results and data might reveal about the prevalence of disease, chains of transmission, and individual and population-level immunity.

Separately, FDA has also reissued emergency use authorizations to Quest Diagnostics and LabCorp to authorize both the Quest SARS-CoV-2 rRT-PCR test and LabCorp COVID-19 RT-PCR test for use with pooled samples. Using pooled samples will allow both labs to test more people quickly using fewer resources. Quest’s test employs a traditional two-stage approach to pooling in which the lab first tests samples as pools and then later individually retests the samples in any positive pools to determine which patient was positive. LabCorp’s test, on the other hand, uses a matrix-based pooling strategy that circumvents the need to retest individual samples as long as the expected (and observed) number of positive samples per matrix is less than or equal to one. Quest’s test is authorized for use with pooled samples containing up to four individual swab specimens collected under observation of a healthcare provider, while LabCorp’s method can test up to five samples in a pool and 25 samples in a matrix.

CDC Receives EUA for Combination SARS-CoV-2, Flu Test

In preparation for the fact that the upcoming flu season will coincide with the ongoing COVID-19 pandemic, the Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the Centers for Disease Control and Prevention (CDC) for its Influenza SARS-CoV-2 (Flu SC2) multiplex assay. This test detects and differentiates between the viral RNA of SARS-CoV-2, influenza A, and influenza B. FDA also previously issued EUAs to BioFire Diagnostics and Qiagen for combination tests that detect multiple respiratory pathogens in addition to the influenza and SARS-CoV-2 viruses. All of these combination tests can be performed with a single patient sample, which could reduce pressure on the testing supply chain. FDA is therefore encouraging additional developers to work with the agency on combination tests that could preserve critical testing resources when this year’s flu season arrives.

Abbott Gets FDA Clearance for Next-Gen Continuous Glucose Monitoring System

The Food and Drug Administration (FDA) has cleared Abbott’s next-generation FreeStyle Libre 2 integrated continuous glucose monitoring system for both adults and children ages 4 and older with diabetes. It is designed to improve on Abbott’s original FreeStyle Libre system, which received FDA approval in July 2018. Like its predecessor, the FreeStyle Libre 2 eliminates the need for diabetes patients to take fingerprick blood samples when measuring their glucose levels. Instead, users wear the FreeStyle Libre 2 next-generation sensor on the back of the upper arm for up to 14 days. The sensor measures glucose levels every minute and features optional real-time alarms, which use Bluetooth technology to automatically alert users when their glucose is high or low. Patients can also view their glucose readings, trend arrow, and 8-hour history by using a handheld reader to scan the sensor. The system is designed for use with a mobile app, too, which Abbott is currently working to bring to the U.S. market.

FDA Gives EUA to Roche Test That Helps Predict Severe COVID-19 Symptoms

Roche has received an emergency use authorization from the Food and Drug Administration for the Elecsys IL-6 test to aid in identifying COVID-19 patients at high risk of severe inflammatory response. In combination with other examinations and vital signs, the test helps physicians to determine early on if a patient with confirmed COVID-19 disease is likely to experience rapid deterioration and require mechanical ventilation. Using serum or plasma samples, the test measures levels of the biomarker interleukin 6 or IL-6, an indicator of acute inflammation in critically ill patients. In COVID-19 patients in particular, this marker serves as an early warning sign that SARS-CoV-2 infection is triggering a cytokine storm, which can lead to the virus’s more severe symptoms such as development and progression of acute respiratory distress syndrome. Roche validated the test in a set of 49 hospitalized COVID-19 patients, 19 of whom required intubation for respiratory support. Using a cutoff of 35 pg/mL, the Elecsys IL-6 assay correctly identified 16 of these 19 patients.

FDA Approves BD Test for Extended Genotyping of HPV

BD has received a pre-market approval supplement from the Food and Drug Administration (FDA) for an expanded version of its BD Onclarity HPV assay. This supplement extends the test’s genotype reporting beyond human papillomavirus (HPV) genotypes 16, 18, and 45 to 14 other high-risk HPV types, including 31, 51, 52, 33/58, 35/39/68, and 56/59/66. According to BD, this makes the Onclarity HPV assay the only FDA-approved test to individually identify and report all of these genotype results in a single analysis.

In addition to this expanded approval, the BD Onclarity HPV assay already has FDA approval for clinical use in cytology-based screening, in a co-testing paradigm, and in primary HPV screening, as well as for use in vaccinated women. BD states that it expects the assay’s extended genotyping capabilities to become increasingly valuable as the previously vaccinated subpopulation ages and the screening population begins to include more women with reduced prevalence of HPV 16 and 18. Studies have also shown that expanded genotyping for cervical cancer screening and triage could improve risk stratification and support risk-based patient management.