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In Brief This Week: Qiagen, Cue Health, Co-Diagnostics, Vela Diagnostics, and More

NEW YORK – Qiagen said this week that its QuantiFeron-TB Gold assay for detection of latent TB was recently expanded by the US Food and Drug Administration to include individuals with weakened immune systems, pregnant women, and children following changes to US Centers for Disease Control and Prevention guidelines.

In addition, Qiagen noted that its battery-powered QiaReach QuantiFeron-TB test, developed in collaboration with Ellume for use in low-resource, high-burden countries, has been approved by the Global Fund's Expert Review Panel Diagnostics. This means that the test may now be procured by public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources, as well as made available through the Stop TB Partnership's Global Drug Facility, Qiagen said.

Separately, Qiagen this week also said it is collaborating with Atila BioSystems on noninvasive prenatal testing to leverage Qiagen's digital PCR technology and sample preparation. Atila has launched the iSAFE Noninvasive Prenatal Test Kit for use on the QIAcuity platform in singleton pregnancies. The research-use-only test can detect targets that may indicate trisomy 21-associated Down syndrome, trisomy 18-associated Edwards syndrome, and trisomy 13-associated Patau syndrome and fetal fractions.

Cue Health said this week that it will develop an Omicron genotyping test for COVID-19. The test, which will be for professional use at the point of care, is being developed as part of the company's ongoing work with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

The San Diego-based firm said it received additional funding from BARDA for the initiative. Cue Health did not disclose the amount of the funding but said it will go toward accelerating the development, validation, and regulatory authorization of a single-plex assay developed solely to detect the Omicron variant in nasal samples.

The test will be compatible with the Cue Health Monitoring System and the Cue Health mobile app. In March, the firm received the first US Food and Drug Administration Emergency Use Authorization for a molecular, at-home COVID-19 test for use without a doctor's prescription.

Co-Diagnostics said last week it has completed its acquisition of Idaho Molecular and Advanced Conceptions for 4.72 million shares of Co-Diagnostics' common stock and 465,000 common warrants. The total value of the deal is about $50 million.

Indian genomics company Mapmygenome said it has opened a laboratory in Delhi in order to meet demand for genomic testing, genetic counseling services, and preventive health tests in north India. The new laboratory provides COVID-19 PCR and antibody testing, blood testing, imaging, genomic testing, and genetic counseling.

Vela Diagnostics said this week that the Centers for Medicare and Medicaid Services has started reimbursing for the company's Sentosa SQ HIV-1 Genotyping Assay. Providers using the assay with the assigned descriptor for therapeutic diagnoses can expect to be reimbursed at $725 using CPT code 0219U for HIV gene analysis, the company said. The assay leverages next-generation sequencing technology on the Sentosa NGS workflow and automates extraction, library, and template preparation, as well as bioinformatics analysis with reference to the Stanford University HIV Drug Resistance Database.

Empower Clinics said this week that its subsidiary Medisure Canada has received a Health Canada Class 2 Medical Device License for the Medisure Vitamin D Rapid Test used to determine whether a patient has vitamin D deficiency. Ontario-based Medisure Canada expects to commercialize the at-home test in the first quarter of 2022.

DevLab said this week that it has obtained accreditation from the College of American Pathologists following an on-site inspection performed through the CAP Accreditation Program. The firm's CLIA-certified clinical laboratory provides diagnostic testing and supports its Contract Research Services division.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.