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Pathway Genomics Gets FDA Registration for Collection Kit

NEW YORK (GenomeWeb News) – Pathway Genomics today said that the US Food and Drug Administration has classified and registered its saliva collection kit as a Class I exempt device.

The device is used to collect samples for the firm's genetic testing services.

The San Diego-based firm said last week that it had received a CLIA Certificate of Accreditation for its lab from the US Department of Health and Human Services' Centers for Medicare and Medicaid. It also recently received accreditation last month from the College of American Pathologists.

The Scan

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.

Sequencing Study Leads to Vaccine Target in Bacteria Behind Neonatal Meningitis

Researchers eBioMedicine track down potential vaccine targets with transposon sequencing on mutant bacteria causing neonatal meningitis in mouse models of the disease.

Multiple Myeloma Progression Influenced by Immune Microenvironment Expression

Researchers in NPJ Genomic Medicine compare RNA sequencing profiles of 102,207 individual cells in bone marrow samples from 18 individuals with rapid or non-progressing multiple myeloma.

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.