CLN - Regulatory Roundup

Roche Alzheimer's Disease and Monkeypox Tests Available After FDA Actions

Regulatory Roundup: March 2023

Roche has received Food and Drug Administration (FDA) authorization for two cerebrospinal fluid (CSF) assays for Alzheimer’s disease and a high-throughput test to detect monkeypox virus.

FDA has granted 510(k) clearance to the company’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays. Used as a pTau181/Abeta42 ratio, the tests measure beta-amyloid and tau protein biomarkers in adults ages 55 and older. The assays achieve 90% concordance with amyloid PET scan imaging and may provide a more affordable and accessible routine option for confirming the presence of amyloid in the brain in the early stages of disease. The assays also offer detection of multiple biomarkers from one draw, with no radiation exposure.

Roche also has received emergency use authorization for the cobas MPXV for use on the cobas 6800/8800 systems. This real-time PCR test qualitatively detects monkeypox virus (MPXV) DNA in lesion swabs by targeting two different regions of the MPXV genome. Both regions are less prone to mutations than other parts of the genome. This dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.

FDA OKS THERMO FISHER MONKEYPOX AND COMPANION DIAGNOSTIC TESTS

The Food and Drug Administration has granted Thermo Fisher Scientific an emergency use authorization for a PCR monkeypox test, as well as de novo classification for a human leukocyte antigen (HLA) typing companion diagnostic.

The monkeypox test is Thermo Fisher’s Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA kit. The test detects non-variola Orthopoxviruses, including monkeypox virus, in about 3.5 hours. Specifically, it is intended for the qualitative detection of DNA from monkeypox virus (clade I/II) and screening for non-variola Orthopoxviruses in human lesion swab specimens.

Thermo Fisher’s SeCore CDx HLA sequencing system was granted de novo classification for use as a companion diagnostic with Kimmtrak (tebentafusp-tebn), Immunocore’s T cell receptor therapy for HLA-A*02:01-positive adults with metastatic or unresectable uveal melanoma, a rare but deadly cancer of the eye. According to the company, this makes SeCore CDx HLA sequencing system the only commercially available HLA typing companion diagnostic.

MORE SARS-COV-2 HOME ANTIGEN TESTS AUTHORIZED BY FDA

The Food and Drug Administration has authorized four new over-the-counter SARS-CoV-2 diagnostic antigen tests from Azure Biotech, ANP Technologies, CorDx, and Beijing Hotgen Biotech. Both Azure Biotech’s Fastep COVID-19 Antigen home test and ANP Technologies’ NIDS COVID-19 Antigen home test show results in 15 minutes and can be used serially within the first 5 days of symptom onset. CorDx’s CorDx COVID-19 Ag test shows results in 10 minutes and can be used serially within the first 7 days of symptom onset. Beijing Hotgen Biotech’s Hotgen COVID-19 Antigen home test shows results in 15 minutes, and also can be used as a serial test within the first 7 days of symptom onset. Additionally, all four tests can be used for people with no symptoms.

FDA CLEARS NEW LABORATORY BLOOD GLUCOSE REFERENCE ANALYZER

Nova Biomedical has received Food and Drug Administration clearance for the Nova Primary as a blood glucose reference analyzer. This new analyzer is designed to serve as a replacement for the discontinued YSI Stat Plus 2300 Glucose and L-Lactate analyzer, a reference and correlation analyzer that was manufactured by YSI.

Like the YSI 2300, Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase. The Nova Primary has a measurement range of 20−900 mg/dL and uses a small, 25 µL venous whole blood or plasma sample that is internally diluted. The analyzer provides results in approximately 2 minutes. In clinical laboratory studies using venous whole blood and plasma, the Nova Primary demonstrated excellent correlation to the YSI 2300 and was traceable to National Institute of Standards and Technology glucose standards., according to the company.

LIQUID BIOPSY COMPANION DIAGNOSTIC FOR LUNG CANCER GETS FDA APPROVAL

The Food and Drug Administration (FDA) has approved Agilent Technologies’ Agilent Resolution ctDx First as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with Krazati (adagrasib). The test is the first liquid biopsy next-generation sequencing assay approved by FDA for this indication and it was developed in collaboration with Krazati’s manufacturer, Mirati Therapeutics. FDA also approved the test for tumor profiling of the epidermal growth factor receptor EGFR gene in NSCLC patients. Additionally, the ctDX First test provides a report that includes broad genomic profiling on 109 genes across four types of alterations: single nucleotide variants, insertions and deletions, copy number amplifications, and fusions.

SEEKIN RECEIVES CE MARK FOR CANCER RECURRENCE MONITORING KIT

SeekIn recently announced that its SeekInCure Cancer Recurrence Monitoring kit received the CE mark and will be launched in the European Union. SeekInCure is a blood-based, tumor-naive approach for molecular residual disease (MRD) assessment and recurrence monitoring for all cancer patients who undergo radical surgery.

Combining genomic and epigenetic signals along with protein tumor marker quantification, the approach dynamically monitors the change of molecular tumor burden in blood after surgery to identify patients with MRD who may benefit most from adjuvant therapies. The test can also be used to monitor for disease recurrence.

SeekInCure requires an 8 mL blood draw within a month after radical surgery to assess whether MRD exists. Meanwhile, peripheral blood can also be collected regularly after surgery to monitor cancer recurrence. SeekInCure does not require tumor analysis, according to company officials.

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