Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio™ plasma focus Dx – the industry’s first and only kitted, pan-solid tumor liquid biopsy test. PGDx elio plasma focus Dx builds on the success of PGDx elio™ tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable. PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay targets guideline-recommended biomarkers to enable more accurate clinical assessments and is coupled with automated bioinformatics… 

Today, the U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices. Synovial sarcoma is a rare form of cancer in which malignant cells develop and form a tumor in soft tissues of the body. This type of cancer can occur in many parts of the body, most commonly developing in the extremities. The cancerous cells may also spread to other parts of the body. Each year, synovial sarcoma impacts about 1,000 people in the U.S. and most often occurs in adult males in their 30s or younger. Treatment typically involves surgery to remove the tumor and… 

Philips hat am Montag Klage gegen PSN Labs eingereicht und behauptet, das Unternehmen habe bei seiner Risikoanalyse des Schallschutzschaums, der in Philips Schlafapnoe-Geräten verwendet wird, Fehler gemacht. Das berichtet MedTech Dive.. Ohne die Ergebnisse von PSN hätte Philips seinen massiven Rückruf von Schlaf- und Atemgeräten anders angegangen, heiße es in der Klage, die beim US-Bezirksgericht für den westlichen Bezirk von Pennsylvania eingereicht wurde. In der Beschwerde behaupte Philips, dass PSN bei seinen Tests und Analysen „zahlreiche eklatante Fehler“ begangen habe und dass PSN sich geweigert habe, die Rohtestdaten an Philips weiterzugeben, mit der Begründung, dass dies die Unabhängigkeit des Testunternehmens beeinträchtigen würde.