CLN - Regulatory Roundup

OralDNA Labs Gets EUA for First Oral Rinse SARS-CoV-2 Test

Regulatory Roundup: November 2020

The Food and Drug Administration (FDA) has granted an emergency use authorization to OralDNA Labs for the OraRisk COVID-19 RT-PCR test, which is the first FDA-authorized test for SARS-CoV-2 that uses a saline oral rinse sample. OralDNA Labs hopes that this type of sample collection will reduce exposure of front-line healthcare professionals to the virus by shortening collection time, in addition to helping with supply chain bottlenecks by reducing the need for swabs. Oral rinse sample collection also avoids the difficulty some individuals have in providing sufficient saliva for direct saliva testing. To collect an oral rinse sample, patients gargle for 30 seconds with a saline solution. Samples are then viable for up to 72 hours and do not require cold pack transportation. Laboratories can also use the OraRisk COVID-19 RT-PCR test with nasopharyngeal swab and nasal swab specimens collected in universal transport media, and nasal swabs collected in oral saline rinse.

FDA Gives EUA to Beckman Coulter for IL-6 Test for COVID-19 Patients

Beckman Coulter has received Food and Drug Administration emergency use authorization for its Access Interleukin-6 (IL-6) assay. Access IL-6 is a fully automated immunoassay designed to detect IL-6 levels in serum and plasma, and is intended to help physicians identify severe inflammatory response in COVID-19 patients and to determine the likelihood that a patient will need intubation with mechanical ventilation. Preliminary studies have shown that IL-6 levels are elevated in patients with severe COVID-19 and that IL-6 may contribute to the severe inflammatory response, also known as cytokine storm, that leads to acute lung injury, pneumonia, or acute respiratory distress syndrome. Testing for IL-6 could enable physicians to treat patients before they need ventilators, which could reduce the number of patients on ventilators and improve outcomes.

Assure Tech Receives EUA for First Point-of-Care Test for SARS-CoV-2 Antibodies

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Assure Tech for the first point-of-care SARS-CoV-2 serology test, a 15-minute lateral flow assay called the Fastep COVID-19 IgG/IgM rapid test device. FDA first authorized this test in July 2020 for emergency use by certain labs to help identify individuals with antibodies to SARS-CoV-2 that indicate recent or prior infection. With this latest EUA, FDA is expanding its initial authorization of the test to include point-of-care testing using fingerstick blood samples. This means that healthcare professionals can now use this device to test for SARS-CoV-2 antibodies in doctors’ offices, hospitals, urgent care centers, emergency rooms, and other patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Assure’s test is also authorized for use with venous whole blood, serum, and plasma.

Roche Gets Expanded FDA Approval for Cervical Cancer Triage Test

The Food and Drug Administration (FDA) has approved expanded use of Roche’s CINtec Plus Cytology, the first biomarker-based triage test for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). This test is designed to support clinical decisions about which of these women will benefit most from immediate follow-up, and was initially approved by FDA in March 2020. This new approval allows labs to use the CINtec Plus Cytology in conjunction with Roche’s cobas HPV test.

The CINtec Plus Cytology test detects the simultaneous presence within a single cell of two biomarkers, p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell therefore signals that a woman is at significantly higher risk for disease. On the other hand, women with negative dual stain results are at significantly lower risk for cervical disease and can be given more time to clear the HPV infection on their own.

FDA Proposes Reclassifying Certain Cytomegalovirus DNA Tests

The Food and Drug Administration has issued a proposed order to reclassify certain cytomegalovirus (CMV) quantitative tests intended for transplant patient management. The agency hopes that this proposed order, when finalized, will provide patients with more timely access to these tests by reducing the regulatory burdens currently associated with them. The order will reclassify certain CMV DNA quantitative assay devices from class III to class II, which means that manufacturers will no longer be required to submit a premarket approval application for these tests, and will instead only have to submit a premarket notification and obtain 510(k) clearance. The order will also rename these devices to “quantitative CMV nucleic acid tests for transplant patient management” and provide special controls that, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for these types of tests. This proposed order will not impact CMV tests that are not based on the detection of CMV DNA.

CE Mark Granted to ProciseDx for POC Tests for Monitoring Immunosuppressive Drugs

ProciseDx has received the CE mark for its infliximab and adalimumab point-of-care drug level tests, which are called the Procise IFX and Procise ADL, respectively, and are designed for use on the ProciseDx system. Standard tests for monitoring these biologic drugs take up to 1 week to return results, which can delay dose adjustment for 2 to 6 weeks. ProciseDx’s new point-of-care tests, on the other hand, deliver therapeutic drug monitoring results in less than 5 minutes using blood from a fingerprick. The company hopes this will improve treatment for patients using infliximab and adalimumab (also known as Remicade and Humira) by enabling immediate decisions on drug dose adjustments at the time of infusion. Infliximab and adalimumab are both immunosuppressive drugs that block the immune regulatory protein tumor necrosis factor-alpha. They are used to treat a number of autoimmune conditions, including a few different types of arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.