The Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Roche’s Elecsys Amyloid Plasma panel, a blood-based Alzheimer’s biomarker test. This panel could enable healthcare professionals to detect Alzheimer’s in its earlier stages. It is a qualitative test that combines the results of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma. Elevations in pTau occur in the early stages of Alzheimer’s, while APOE E4 is a marker for the disease’s most common genetic risk factor. Patients who test negative with the Elecsys Amyloid Plasma panel are unlikely to have Alzheimer’s, which means that their clinicians should investigate other potential causes of cognitive decline.
Roche has also received FDA emergency use authorization for the cobas SARS-CoV-2 Duo. According to the company, this test is the first automated, real-time reverse transcription PCR assay for the qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. Only the qualitative results of the test are intended for use as an aid in the diagnosis of COVID-19. However, Roche said that the potential benefits from reporting a standardized viral load along with the qualitative result may help clinicians in the assessment and monitoring of infected patients across laboratories and over time. The quantitative result is traceable to the World Health Organization International Standard for SARS-CoV-2 RNA.
Anitoa Systems’ Monkeypox PCR Test Receives CE Mark
The CE mark has been granted to Anitoa Systems for its PCR-based monkeypox test. This test detects orthopoxvirus and monkeypox virus gene targets in samples collected from patients suspected of having a monkeypox infection. Specifically, it amplifies regions of the F3L and B7R genes of the virus. Sample types that can be used with the test include oropharyngeal swabs, nasopharyngeal swabs, serum, plasma, and human pustular or vesicular rash specimens.
Designed to run on the Maverick qPCR instrument, which is portable and battery-operated, the test can be performed in near-patient settings, thus eliminating the need to transport patient samples to central labs for testing. It provides results in about 45 minutes.
Anitoa already has a presence in Africa and has started deploying this test in select clinics in this region. The company is also prepared to distribute this test worldwide as the need arises.
FDA Approves Preventiongenetics’ Companion Diagnostic for Weight Management Drug.
PreventionGenetics has received Food and Drug Administration (FDA) approval for the POMC/PCSK1/LEPR genetic test, a companion diagnostic that identifies patients who may benefit from the weight management drug Imcivree (setmelanotide).
Imcivree is marketed by Rhythm Pharmaceuticals and was approved by FDA in 2020 for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. However, Imcivree is not indicated for the treatment of patients with obesity due to suspected POMC, PCSK1, or LEPR deficiency if their POMC, PCSK1, or LEPR variants are classified as benign or likely benign. PreventionGenetics’ test therefore helps determine whether a patient should receive Imcivree by confirming variants in the POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
Sysmex America gets FDA Clearance for Residual White Blood Cell Counting
Sysmex America has received Food and Drug Administration (FDA) clearance for the addition of residual white blood cell (WBC) counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode. This means that the XN-10 now supports red blood cell, platelet component testing, and residual WBC counting all in asingle sample aspiration. According to the company, this also makes the XN-10 the first and only automated hematology analyzer to earn FDA clearance for residual WBC counting.
The instrument is available as either a single module or as twin coprimary analyzers, and it can be installed as a tabletop analyzer or placed on a wagon. An RU-20 reagent unit can be added to either model to increase efficiency. Additionally, the twin coprimary analyzers come with an automatic, continuous-feed sampler and are capable of both open- and closed-tube testing.
CE Mark Granted to Thermo Fisher Scientific for Respiratory Viral Panel
Thermo Fisher Scientific has earned the CE mark for its Applied Biosystems TaqPath Respiratory Viral Select panel. This molecular assay panel detects five common viruses that cause the common cold, bronchiolitis, croup, influenza-like illnesses, and pneumonia. The viruses are adenovirus, human metapneumovirus, rhinovirus/enterovirus, and parainfluenza virus. The panel also identifies coinfections.
The TaqPath Respiratory Viral Select panel provides results in approximately 3 hours. It’s scalable, enabling laboratories to run anywhere from 1 to 94 samples simultaneously, depending on the needs of the population the lab is servicing. The panel uses the same workflow as the TaqPath COVID-19, Flu A/B, RSV combo kit when using the Applied Biosystems QuantStudio 5 PCR system.
Currently, it is only available in select European, Middle Eastern, and African countries.
Biocartis Gets CE Mark for Idylla Genefusion Panel for Lung Cancer
The CE mark has been given to Biocartis for its Idylla GeneFusion panel. Using a single cartridge, the panel detects a wide range of actionable targets relevant in non-small cell lung cancer management, including ALK, ROS1, RET, and MET exon 14 skipping mutations.
The panel provides results within 3 hours and combines two different approaches: direct detection of known fusion isoforms via reverse transcription quantitative PCR and detection of fusion events without knowledge of the fusion partners, which is accomplished by analyzing expression ratios between the 5’ and 3’ ends of the gene of interest.
Additionally, the Idylla system is designed to use smaller samples than most oncology biomarker tests, thereby helping to save tissue specimens.