Scientists at UCLA Health have received Food and Drug Administration emergency use authorization to begin using a new method for SARS-CoV-2 detection based on the sequencing technology SwabSeq. This method is capable of testing thousands of SARS-CoV-2 samples at the same time, providing individual results in 12 to 24 hours. This could enable the expansion of SARS-CoV-2 testing particularly for asymptomatic patients, not only because this technology is highly scalable, but also because it won’t be limited by the same supply chain bottlenecks that have constrained polymerase chain reaction testing. SwabSeq works by adding a unique molecular bar code to each sample in the first step of its processing. The samples are then combined in a sequencer, and the bar codes enable labs to identify which specific sample(s) is positive for the virus. Labs can use this method with any sample type, including nasopharyngeal and oropharyngeal swabs and saliva.
Abbott, Beckman Coulter Earn FDA EUAs for SARS-CoV-2 IgM Antibody Tests
The Food and Drug Administration (FDA) has issued emergency use authorizations to both Abbott and Beckman Coulter for their new SARS-CoV-2 immunoglobulin M (IgM) antibody tests. Both companies already have FDA-authorized tests on the market for SARS-CoV-2 IgG antibodies, which are the antibodies that typically persist the longest in the body after infection. In comparison, IgM antibodies are most useful for identifying a recent infection, as these antibodies become undetectable weeks to months following infection. Studies have demonstrated that Abbott’s test, the AdviseDx SARS-CoV-2 IgM, has 99.56% specificity and 95% sensitivity for patients tested 15 days after symptom onset. The test is available for use on the company’s Architect and Alinity platforms. Beckman Coulter’s assay, on the other hand, specifically detects IgM antibodies to the receptor binding domain of the SARS-CoV-2 spike protein. The test has a specificity of 99.9% and a sensitivity of 98.3%.
FDA Authorizes Two New Saliva Collection Devices for SARS-CoV-2 Testing
Spectrum Solutions and DNA Genotek, a subsidiary of OraSure Technologies, have both received Food and Drug Administration emergency use authorizations (EUA) for their respective saliva collection devices for SARS-CoV-2 testing: the SDNA-100 and the Omnigene Oral (OM-505, OME-505). Both devices are designed for the self-collection and transport of samples for polymerase chain reaction testing, and both stabilize and neutralize viral RNA transcripts. The two collection kits can be used either in a healthcare setting or unsupervised at home when used as part of an approved or validated at-home test kit.
Spectrum’s SDNA-100 first received an EUA in March that authorized Rutgers Clinical Genomics Laboratory to use this kit for saliva SARS-CoV-2 testing. With this new EUA, other laboratories will now also be able to use this kit with a broad range of platforms and assays, including those from PerkinElmer, Thermo Fisher, Roche, and Qiagen.
FoundationOne CDx Gets FDA Approval for Use as a Co-Diagnostic for Larotrectinib
The Food and Drug Administration (FDA) has approved Foundation Medicine’s next-generation sequencing (NGS)-based FoundationOne CDx test as a companion diagnostic for patients with solid tumors who are eligible for treatment with larotrectinib (Vitrakvi). Larotrectinib received FDA approval in 2018 for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. To identify patients who might benefit from larotrectinib, the test detects fusions in the NTRK1, NTRK2, and NTRK3 genes in DNA isolated from tumor tissue specimens. FDA based this approval on a study that used the FoundationOne CDx assay to retrospectively test available tumor tissue samples from patients enrolled in the clinical trials that supported the approval of larotrectinib.
FDA OKs clonoSEQ Assay for Chronic Lymphocytic Leukemia Patients
The Food and Drug Administration (FDA) has cleared Adaptive Biotechnologies’ clonoSEQ assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). This clearance expands on the existing FDA-authorized uses of clonoSEQ, which include the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia patients.
FDA based its clearance of clonoSEQ in CLL on clinical validation data from two clinical trials. The first trial enrolled 337 patients and found that those with undetectable MRD in blood by clonoSEQ at 3 months post-treatment had a nearly seven-fold reduced risk of disease progression compared with patients who did not reach undetectable MRD. At 30 months post-treatment, the probability of disease for patients with undetectable MRD dropped to 5%, compared to a 36% probability for patients with detectable disease. The second clinical trial supported these findings.
FDA Clears Scopio Labs’ AI-Powered Full Field Peripheral Blood Smear Application
Scopio Labs, a provider of full field morphology, has received Food and Drug Administration clearance for Full Field PBS, the company’s X100 with full field peripheral blood smear (PBS) application. This application also received the CE mark in Europe earlier this year. Scopio designed this instrument to improve upon current digital hematology solutions, most of which do not showcase all required regions of interest in a PBS slide and only capture snapshots of cells. Using advanced computational photography imaging and tailored artificial intelligence tools, Full Field PBS gives clinical laboratories the ability to capture digital scans with full field view of the monolayer and feathered edge at 100X oil immersion resolution level. Additionally, the Full Field PBS uses adaptive monolayer identification in support of long and short smears, and automates the analysis process by pre-classifying 200 white blood cells, providing platelet pre-estimate, and enabling red blood cell morphology evaluation.