Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that its Elecsys® Neurofilament Light Chain (NfL) test has received CE mark approval for the detection of neuroinflammation in patients diagnosed with relapsing remitting multiple sclerosis (RRMS).1 The test brings meaningful innovation to MS disease management, offering clinicians a minimally invasive way to monitor the biological damage caused by multiple sclerosis. Using a simple blood test to measure NfL – a protein released during nerve cell injury – Elecsys NfL provides a picture of the neuroinflammation associated with multiple sclerosis, and could help to make more regular monitoring a reality for more people living with the disease.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Roche (SIX: RO, ROG; OTCQX: RHHBY) unveiled today its proprietary, breakthrough sequencing by expansion (SBX) technology, establishing a new category of next-generation sequencing. SBX chemistry, combined with an innovative sensor module, offers ultra-rapid, high-throughput sequencing that is both flexible and scalable for a broad range of applications.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the commercial launch of the first in a family of high-throughput, robotics-compatible reagent kits that will enable automation to ensure greater consistency and increased efficiency of large-scale, single-cell discovery studies.
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
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.
Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, announced that effective today it has acquired Fluent BioSciences, developer of an emerging and highly differentiated single-cell technology.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the first clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection.
QIAGEN announced today the expansion of its digital PCR (dPCR) offering for the development of cell and gene therapies in the biopharma industry.
Tempus, a leader in artificial intelligence and precision medicine, today announced a new collaboration to develop a companion diagnostic (CDx) test with TScan Therapeutics, a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of cancer patients.
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