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Quest Diagnostics Post-COVID Panels

Quest Diagnostics has launched two laboratory panels for individuals experiencing long-term effects following COVID-19 infection. The Post-COVID-19 Basic Panel is composed of c-reactive protein, thyroid function, vitamin B12, vitamin D, and urinalysis while the Post-COVID-19 Expanded Test Panel includes a basic metabolic panel, a hepatic function panel, a complete blood count, and a measurement of ferritin levels. Both panels are available through Quest's consumer-initiated testing service priced from $149 to $199.

Bionano Laboratories OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV Tests

Bionano Laboratories, the clinical services arm of Bionano Genomics, has launched two new optical genome mapping (OGM)-based laboratory-developed tests (LDTs), OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV. The postnatal assay tests peripheral blood samples from individuals who have been diagnosed with autism spectrum disorder (ASD), intellectual disability, developmental delay, epilepsy and rare undiagnosed genetic disease, and others. According to the company, the report of this test will include a whole genome analysis of structural variants (SVs) and will screen for the common CGG expansion in the FMR1 gene that may indicate fragile X syndrome.

The prenatal test may be indicated for fetuses where a genetic anomaly is suspected, including abnormal ultrasound or positive non-invasive prenatal screening (NIPS), previous child with chromosomal abnormality, and history of recurrent pregnancy loss, the company said. This test will generate a report that includes whole-genome analysis to assess for SVs of diagnostic and prognostic value.

NeoGenomics Radar Assay; Neo Comprehensive-Solid Tumor and Neo Comprehensive-Myeloid Disorders

NeoGenomics has commercially launched its Radar liquid biopsy test for minimal residual disease (MRD) for clinical use. The assay has been available for use in clinical research studies and pharmaceutical collaborations for more than a year, but it will now be available to US clinicians treating breast, colorectal, lung, and head and neck cancer patients. The laboratory-developed test tracks up to 48 tumor-specific variants in cell-free DNA in a patient's blood plasma and is intended to detect MRD and recurrence after curative intent or definitive treatment. 

NeoGenomics this week also announced the commercial availability of new sequencing-based comprehensive genomic profile tests Neo Comprehensive-Solid Tumor and Neo Comprehensive-Myeloid Disorders.

Neo Comprehensive-Solid Tumor is the company's largest solid tumor, pan-cancer assay available to date. It detects genomic alterations that are most relevant in diagnosis, therapy selection, prognosis, and clinical trials, the company said. The panel assays 517 genes using DNA and RNA sequencing, and includes microsatellite instability and tumor mutational burden.

Neo Comprehensive-Myeloid Disorders enhances the company's previous myeloid panel, making it the largest DNA and RNA sequencing-based myeloid panel on the market, the company said. It analyzes 164 genes and includes single-nucleotide variants, copy number variants, insertions and deletions, and fusions.

NeoGenomics also said it is introducing two software resources to complement its testing menu: NeoAccess, a test requisitioning tool with clinical decision support; and NeoSeek software that enables clinicals to mine their previous testing data to identify patients who may be biomarker-eligible for a new therapy or clinical trial.

Cue Health Herpes Panel, Liver Panel, More

Cue Health has launched a suite of diagnostic tests with at-home sample collection through its Cue Care test-to-treat platform. Those tests include heart health tests, sexual health assays, women's health test kits, metabolic health tests, and wellness tests. Each kit includes supplies needed for at-home sample collection and samples are then sent to an independent CLIA-certified laboratory for testing. When results are returned via the Cue Health app, users have the opportunity to schedule a telehealth visit and, if necessary, receive treatment through the Cue Care platform. 

Cue is offering multiple tests, including a heart health panel, a cardiac risk test, a chlamydia and gonorrhea combination test, a herpes panel, men's and women's sexual health panels, a women's fertility panel, a liver panel, a kidney panel, a food sensitivity panel, a vitamin D test, and a colon cancer screening test. All of the tests are new to being offered by Cue, a spokesperson said via email. 

PathAI AISight, AIM-PD-L1 NSCLC RUO Algorithm

PathAI has launched its AISight digital pathology platform along with its AIM-PD-L1 NSCLC RUO Algorithm in an early access program. AISight was designed with input from more than 200 pathologists and can be used by physicians, academic institutions, biopharma companies, and contract research organizations to support artificial intelligence-driven research. The AIM-PD-L1 NSCLC RUO algorithm analyzes non-small cell lung cancer surgical specimens and provides quantification and visualizations of PD-L1 positivity on tumor and immune cells. It is intended for use in immune oncology research applications and was trained on a real-world dataset of more than 5,000 samples.

Cardio Diagnostics PrecisionCHD

Cardio Diagnostics has launched its PrecisionCHD test for detecting coronary heart disease. The test uses epigenetic and genetic biomarkers, as well as a proprietary machine-learning model, to detect heart disease in men and women. It also has an accompanying Actionable Clinical Intelligence, which maps a patient's biomarker profile onto modifiable risk factors like diabetes, hypertension, and smoking. The test can be administered in provider settings or at home with self-sampling and telehealth visits. The technology will be available exclusively for existing customers, with a nationwide rollout to follow.

Agilent Technologies Bravo NGS On-Deck Thermal Cycler

Agilent Technologies has launched an on-deck thermal cycler that integrates with the Agilent Bravo NGS automated liquid handling platform. The product adds thermal cycling as part of an automated protocol for next-generation sequencing, endpoint PCR, and cell-based applications, and the cycler is particularly helpful for applications such as library preparation and target enrichment during NGS workflows, Agilent said.

Roche IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody, ATRX Rabbit Polyclonal Antibody

Roche has launched two new antibodies, the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody, to identify mutations in patients with brain cancer. The IDH1 antibody can detect the IDH1 R132H mutation in adult-type gliomas and in acute myeloid leukemia, which is associated with relatively favorable prognosis and can help stratify patients in clinical trials. The ATRX antibody detects a mutation in the ATRX gene. Both products are fully automated on Roche's BenchMark instruments and are available in the US. 

iGene Laboratory FetalExome Test

Singapore-based molecular diagnostics firm iGene Laboratory, a subsidiary of Inex Innovate, has launched the FetalExome test, a whole-exome sequencing test for pregnant women with prenatal ultrasound imaging that shows fetal structural anomalies suggestive of genetic causes. The test is offered as a trio analysis, where exome sequencing is performed on both parents and the fetus.

Biological Dynamics' ExoVita Pancreas

Biological Dynamics said this week that it has validated and launched a laboratory-developed test, ExoVita Pancreas, through the company's CLIA-certified and CAP-accredited lab. The firm's assay platform involves isolation of exosomes with particular protein biomarkers from a standard blood sample, in this case to detect stage 1 and stage 2 pancreatic ductal adenoma carcinomas.

Biological Dynamics said that it intends to further validate the assay in a trial called ExoLuminate, which is currently enrolling patients with a high risk for pancreatic cancer. Eligible patients include those with a known familial or genetic predisposition, or certain clinical symptoms.