The US Food and Drug Administration recently granted Emergency Use Authorization for an over-the-counter combination COVID-19 and influenza test developed by Acon Laboratories.

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its SeCore™ CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA® (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-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-approved or cleared companion diagnostic devices. Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults.1,2

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.

Agilent Technologies Inc., (NYSE: A) today announced that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy.

The US Food and Drug Administration recently granted Emergency Use Authorization for a combination COVID-19 and influenza point-of-care test developed by Nano-Ditech.

Lawmakers have told the Food and Drug Administration to suspend efforts to implement its final rule on laboratory developed tests (LDTs).

Diasorin (FTSE MIB: DIA) today announced that the Food and Drug Administration (FDA) has granted de-novo authorization for the Simplexa® C. auris Direct kit to test patients suspected of Candida auris colonization and aid in preventing potential spread in healthcare settings. This real-time polymerase chain reaction (RT-PCR) assay is used for the direct in vitro qualitative detection of C.auris DNA from a swab of axilla/groin from patients suspected of C. auris colonization, and detects the six C.auris clades that are circulating globally.

Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).

Every year 11 million people worldwide die of sepsis and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria. For clinicians to rapidly optimize therapy and improve patient care, fast and accurate antimicrobial susceptibility testing (AST) results and interpretation are critical. In addition, fast AST can enable antimicrobial stewardship (AMS) programs which has the potential to reduce antimicrobial resistance (AMR), identified as a global threat by WHO.