CLN - Regulatory Roundup

FDA Authorizes SARS-CoV-2 Tests That Use Samples Self-collected by Patients

Regulatory Roundup: June 2020

In an effort to lower the risk of infection for healthcare professionals involved in sample collection for SARS-CoV-2 testing, as well as to save personal protective equipment, the Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two SARS-CoV-2 tests that use self-collected samples. One of these tests is the first that FDA has authorized to offer a home collection option for SARS-CoV-2. Specifically, FDA reissued the EUA for LabCorp’s COVID-19 RT-PCR test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 test home collection kit. This kit provides patients with a specific Q-tip style cotton nasal swab and saline for sample collection. Once patients self-swab to collect their nasal sample, they mail their sample in an insulated package to LabCorp for testing. LabCorp intends to make the Pixel home collection kits available to consumers in most states with a doctor’s order.

Now that this is an option for COVID-19 testing, however, AACC is concerned that consumers will not be able to collect nasopharyngeal samples correctly and that this could cause false negative results. In a letter to FDA, the association has therefore asked the agency to consider issuing a warning about home-collected samples for COVID-19 testing. As AACC states in the letter, “We share FDA’s goal of expanding consumer access to COVID-19 testing and are confident in LabCorp’s ability to obtain analytically correct results from the test. However, serious preanalytical concerns associated with home specimen collection kits exist that must be taken into consideration before deploying these kits widely and allowing physicians to make clinical decisions based on results gained from this … approach.”

The second self-collection test that FDA has authorized—developed by Rutgers University’s cell and DNA biorepository, RUCDR Infinite Biologics, in collaboration with Spectrum Solutions and Accurate Diagnostic Labs—uses saliva samples that patients self-collect at testing sites by spitting into a sealable tube. This saliva-based test is currently available through RWJBarnabas Health network, New Jersey’s most comprehensive healthcare system.

With New FDA Approval, Roche’s HPV Test Can Be Used on the cobas 6800/8800

The Food and Drug Administration (FDA) has approved Roche’s cobas HPV test for use on the company’s fully automated, high-throughput cobas 6800/8800 systems. This test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Specifically, the test detects HPV genotypes 16 and 18—the two genotypes responsible for about 70% of all cervical cancers—and reports the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. FDA originally approved this test for the cobas 4800 system in 2011 using data from the ATHENA (Addressing the Need for Advanced HPV Diagnostics) trial. For this most recent approval, the agency considered data from the registrational IMPACT (Improving Primary Screening and Colposcopy Triage) trial, which enrolled almost 35,000 women in the U.S. for the purpose of clinically validating the cobas HPV for use on the cobas 6800/8800 systems.

FDA Approves Foundation Medicine’s Co-Diagnostic for Bile Duct Cancer

Foundation Medicine has received Food and Drug Administration (FDA) approval for FoundationOne CDx, a companion diagnostic for Incyte’s Pemazyre (pemigatinib), which is a selective fibroblast growth factor receptor (FGFR) inhibitor approved for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other related rearrangement. FGFR2 fusions and related rearrangements occur in 10%–16% of intrahepatic cholangiocarcinoma patients. FoundationOne CDx is a comprehensive genomic profiling assay that identifies patients with these FGFR2 fusions or related rearrangements who might benefit from treatment with Pemazyre.

Previously, FDA had already approved FoundationOne CDx as a companion diagnostic for 20 unique therapies across multiple other solid tumor types. Using next-generation sequencing, the test analyzes DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden.

FDA Proposes Reclassification of HCV Tests From Class III to II

The Food and Drug Administration (FDA) has proposed reclassifying two types of hepatitis C virus (HCV) diagnostic tests from class III to II. The two types of HCV devices that FDA is proposing to reclassify are nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA and certain HCV antibody devices intended for the qualitative detection of antibodies to HCV. If this reclassification is finalized, manufacturers would be able to submit these tests through FDA’s 510(k) pathway for clearance instead of through the premarket approval pathway. For both HCV test types, FDA reviewed medical device reporting databases and found that there are a low number of reported events for these devices relative to the number of tests conducted using them. All recalls of these devices have also been resolved without any identified patient harm. When taken all together, FDA believes this indicates a good safety record for these HCV tests and that special controls under the class II device designation will effectively mitigate the risks associated with these devices.

Siemens Healthineers Gets FDA Nod for Point-of-Care Blood Gas Analyzer

The Food and Drug Administration has cleared Siemens Healthineers’ RAPIDPoint 500e Blood Gas analyzer, a point-of-care instrument that is intended to help diagnose and monitor critically ill patients. The analyzer, is already available in countries requiring the CE mark. Using 100 μL of whole blood or pleural fluid, this instrument generates a full panel of blood gas, electrolyte, metabolite, car-bon monoxide (CO)-oximetry, and neonatal bilirubin results in approximately 1 minute. As a fully cartridge-based analyzer it does not have any maintenance requirements; the measurement cartridge includes the planar sensors, sample probe, and CO-oximetry chamber, all of which are replaced with every new cartridge. The RAPIDPoint 500e also includes Integrisense Technology, which performs frequent quality and blood integrity checks before, during, and after every patient sample and features three levels of independent automatic quality control, multiple calibration routines, and advanced software algorithms.

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