After December 31, 2021, the Centers for Disease Control and Prevention (CDC) will withdraw its request to the Food and Drug Administration (FDA) for emergency use authorization (EUA) of the CDC 2019-Novel Coronavirus Real-Time RT-PCR diagnostic panel. CDC is announcing this in advance so that any clinical laboratories that are using this test have adequate time to select and implement one of the many FDA-authorized alternatives.
CDC first introduced this assay for detection of SARS-CoV-2 in February 2020. Now, however, the agency has decided to voluntarily withdraw its request for EUA primarily because “hundreds of SARS-CoV-2 [polymerase chain reaction (PCR)] tests have received EUAs and are widely available,” said AACC President Stephen R. Master, MD, PhD, FADLM. This means that “CDC’s test is no longer needed to fill an unmet testing need.”
As laboratories look for an alternative to CDC’s test, the agency encourages labs to consider adopting a multiplexed method that detects and differentiates between SARS-CoV-2 and influenza viruses. This will facilitate a more cost-efficient approach to testing once flu season arrives, according to Master. CDC actually has a separate EUA for such a test—one that detects and distinguishes between SARS-CoV-2, influenza A, and influenza B—that it will be maintaining. Moving forward, CDC and other public health laboratories plan to use this multiplex test so they can simultaneously monitor flu activity in addition to SARS-CoV-2.
FDA Grants EUA to Roche for PCR-Based SARS-CoV-2 Point-of-Care Test
Roche has earned Food and Drug Administration emergency use authorization for the cobas SARS-CoV-2 nucleic acid test for use on the cobas Liat system. According to Roche, this singleplex test is the first real-time reverse transcriptase-polymerase chain reaction test that identifies SARS-CoV-2 infection within 20 minutes, and that is authorized to screen both symptomatic and asymptomatic persons at the point of care. It also offers broad SARS-CoV-2 strain coverage as monitored by Roche’s ongoing variant surveillance program. The cobas Liat system fully automates the testing process and features a simplified workflow that enables healthcare professionals to perform this test with minimal training. The cobas SARS-CoV-2 nucleic acid test is intended for use at a wide range of point-of-care settings, including emergency and primary care settings, physician offices, and other SARS-CoV-2 screening locations. It is also available in markets accepting the CE mark.
Promega Receives FDA Clearance for Lynch Syndrome Screening Test
The Food and Drug Administration has cleared Promega’s OncoMate MSI Dx analysis system, which determines microsatellite instability (MSI) status in colorectal cancer tumors. High-frequency MSI is an indication that patients and their family members should be referred for further genetic testing for Lynch syndrome, an inherited condition that increases the risk of developing colorectal and other cancers. Promega’s OncoMate MSI Dx is based on the company’s research-use-only fluorescent, multiplex polymerase chain reaction-based fragment-sizing technology, which has been used to test for MSI status in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications. The OncoMate MSI targets five mononucleotide repeat markers that align with guidelines such as the National Cancer Institute’s “Revised Bethesda Guidelines for Hereditary Nonpolyposis Colorectal Cancer (Lynch syndrome) and Microsatellite Instability.” From sample collection to result, the test takes 10 hours, and it can be performed using a single formalin-fixed paraffin-embedded section.
FDA Clears Inova’s Digital Multi-Analyte System, Celiac Disease Test
Inova Diagnostics has received 510(k) clearance from the Food and Drug Administration for its Aptiva system and Aptiva Celiac Disease IgA assay, both of which previously received the CE mark in August 2020. The Aptiva is a fully automated, high-throughput digital multi-analyte system. It features 150-sample rack capacity, which reduces the number of daily interventions, and a 6.5-hour consumable walkaway time. It also uses a particle-based multi-analyte technology (PMAT) that processes multiple analytes simultaneously from a patient sample. PMAT enables Aptiva to deliver up to 720 results per hour using a 12-analyte test cartridge, thereby allowing the laboratory to complete its workflow in a single shift. On the Aptiva system, Inova eventually plans to include tests for seven additional autoimmune disease states that detect more than 60 analytes, with the goal of closing the seronegative gap, e.g., identifying autoimmune disease states in patients who would normally test negative for them.
Qiagen Earns CE Mark for Human Adenovirus Test
The CE mark has been granted to Qiagen for its NeuMoDx HAdV Quant assay, which is designed to identify and quantify human adenovirus (HAdV) DNA and runs on the NeuMoDx 96 and 288 molecular systems. Qiagen developed this new assay in partnership with Sentinel Diagnostics. The test uses Qiagen’s automated, three-step NeuMoDx solutions, which extract DNA from blood or urine to isolate the target nucleic acids and then conduct real-time polymerase chain reaction to target conserved sequences in the HAdV genome. The NeuMoDx HAdV Quant assay is part of the NeuMoDx transplant assay menu, which also includes CE-marked tests for cytomegalovirus, Epstein-Barr virus, and BK virus viral load monitoring. These tests are all intended for the management of immunocompromised patients, such as those who have undergone organ transplantation.
Japan Approves Amoy Diagnostics’ Lung Cancer CoDiagnostic Panel
Amoy Diagnostics has received approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) to produce and market the AmoyDx Pan Lung Cancer (PLC) polymerase chain reaction panel in Japan. Developed in collaboration with Riken Genesis and Precision Medicine Asia, this test is intended for use as a companion diagnostic for multiple cancer therapeutics. It can be performed on formalin-fixed paraffin-embedded tissue and fresh frozen tissue in which the presence of tumor cells has been confirmed, and it can simultaneously evaluate the presence of up to 11 driver genes: EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3. So far, the MHLW has approved the detection of four of these genes (EGFR, ALK, ROS1, and BRAF) with the AmoyDx PLC Panel for nine associated targeted therapies for non-small cell lung cancer. These therapies include gefitinib, erlotinib hydrochloride, afatinib maleate, osimertinib mesylate, crizotinib, alectinib hydrochloride, brigatinib, and combined administration of dabrafenib mesylate and trametinib dimethyl sulfoxide.