CLEW Medical, a company that specializes in artificial intelligence (AI)-powered predictive analytics, has received Food and Drug Administration 510(k) clearance for CLEWICU, the company’s AI-based intensive care unit (ICU) software that predicts hemodynamic instability in adult patients. CLEWICU continuously monitors and categorizes a patient’s risk of clinical deterioration and enables early intervention by providing notification that a patient is developing hemodynamic instability up to 8 hours in advance. The system also identifies low-risk patients who are unlikely to deteriorate. Both of these functions could enable better ICU resource management and optimization, which is critical now that ICUs are dealing with unprecedented volume levels as a result of the COVID-19 pandemic.

CLEWICU bases its predictions on a broad range of patient data, including the patient’s laboratory test results, vital signs, and history of medications, medical procedures, and prior hospitalizations. The system ingests this data either through periodic direct querying of the SQL database of the electronic health record or by receiving real-time HL7 messages from the hospital’s interface engine. CLEWICU then analyzes the data in near real-time using AI-based algorithms and machine-learning models that are trained to identify the likelihood of significant clinical events occurring for patients in the ICU.

FDA Grants EUAs for SARS-CoV-2/Flu Combo Tests

The Food and Drug Administration (FDA) has granted emergency use authorizations (EUA) to three new tests that detect SARS-CoV-2, influenza A, and influenza B. These tests are BD’s SARS-CoV-2/Flu assay, Bio-Rad’s Reliance SARS-CoV-2/FluA/FluB RT-PCR assay kit, and Thermo Fisher’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo kit. The EUA for BD’s test in particular includes information in the test’s instructions for use that addresses testing for SARS-CoV-2 variants, including those that originated in the U.K. and South Africa. A computer analysis has shown that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for BD’s test, which means that it can identify these variants specifically. It shares this capability with BD’s standalone SARS-CoV-2 test for the BD Max system, which already has an FDA EUA. The BD SARS-CoV-2/Flu assay also runs on the BD Max system, returns results in 2 to 3 hours, and has received the CE mark as well.

Roche Gets FDA Nod for BK Virus Test

The Food and Drug Administration (FDA) has cleared Roche’s cobas BKV test for use with urine samples stabilized in cobas polymerase chain reaction (PCR) media. This test, which FDA previously cleared for use with EDTA plasma samples, aids in the management of BK virus (BKV) in transplant patients and is designed to run on the cobas 6800/8800 systems. Because BKV DNA levels often increase in urine before they increase in plasma, healthcare professionals can now use this test for early prediction of impending infection. The test uses real-time PCR with dual-target technology, which guards against the risk of sequence variations in the virus impacting the test’s accuracy. It has a limit of detection of 21.5 IU/mL and an expanded linear range of 21.5 IU/mL to 1x108 IU/mL in EDTA plasma, while in stabilized urine samples, it has a limit of detection of 12.2 IU/mL and a linear range from 200 IU/mL to 1x108 IU/mL.

CE Mark Granted to Qiagen for Automated Molecular Sample Processing Platform

Qiagen has received the CE mark for the QIAcube Connect MDx, a flexible platform for automated DNA, RNA, and protein sample processing. The system fully automates the lysis, binding, washing, and elution steps of the Qiagen spin columns used to process molecular samples, and standardizes the purification of these samples as well. With features such as fully automated worktable decontamination, the system is designed to increase lab process safety, making it suitable for preparation of SARS-CoV-2 and other viral samples for diagnostic testing. The QIAcube Connect MDx comes with diagnostic and research protocols that can be used in combination with Qiagen’s QIAamp DSP kits and PAXgene Blood RNA extraction kits, meaning that overall, labs can use this system with more than 80 Qiagen kits and more than 140 standard protocols.

Health Canada Authorizes Saliva Collection Device for SARS-CoV-2 Testing

OraSure Technologies has earned an Interim Order authorization from Health Canada for the Omnigene Oral (OME-505) saliva collection device, which is a product of OraSure’s Ottawa, Ontario-based subsidiary DNA Genotek. This device is intended for the collection, stabilization, and transport of saliva specimens suspected of containing SARS-CoV-2 RNA that will be analyzed with molecular diagnostic tests for the virus. With this Interim Order, patients in Canada can now use the Omnigene Oral for specimen self-collection, either at home or while supervised by a healthcare worker in a healthcare setting, and healthcare workers can also use the device for specimen collection. However, clinical laboratories adding saliva testing to their workflow must still validate the use of the Omnigene Oral with their assays prior to SARS-CoV-2 testing in accordance with applicable regulations.

Omnigene Oral also has emergency use authorization from the Food and Drug Administration, as well as the CE mark for in vitro diagnostic use in the European Union.

FDA Clears Inova Test for Systemic Lupus Erythematosus

Inova Diagnostics has received 510(k) clearance from the Food and Drug Administration for the Nova Lite DAPI dsDNA Crithidia luciliae kit. This kit aids in the qualitative and/or semiquantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies using the Nova View Automated Fluorescence Microscope or manual fluorescence microscopy. The presence of anti-dsDNA antibodies can be used in conjunction with other serological and clinical findings to aid in the diagnosis of systemic lupus erythematosus. When used together, the Nova Lite kit and the Nova View are designed to reduce laboratory turnaround time and technician hands-on time for the detection and titering of these antibodies.