According to the company, KEYTRUDA has been approved to treat patients with locally advanced or metastatic NSCLC whose tumors express PD-L1, as determined by the companion diagnostic assay
, and who have received at least one prior chemotherapy regimen.
Amarantus Diagnostics' MSPrecise is a neuroimmunology-based next-gen sequencing diagnostic assay
for multiple sclerosis.
Under the terms of the expanded collaboration agreement, NanoString continues the flexibility to independently develop and commercialize additional indications for the resulting diagnostic assay
Millipore's OEM Healthcare Division offers one of the largest selections of membranes, manufactured to the highest standards of quality and consistency, for clinical diagnostic assays
Graham Mullis, CEO of Lab21, commented: "We are pleased to enter into a new companion diagnostic assay
partnership with a major pharma company to develop and co-brand this assay.
Diagnostic products company Hologic (NasdaqGS:HOLX) revealed on Monday that it has received US Food and Drug Administration (FDA) emergency use authorisation for its new, diagnostic assay
for Zika virus infection, called Aptima Zika Virus assay.
Finally, an important aspect in developing a diagnostic assay
is to use a rapid and easily automated system that works on virtually all persons who carry the disease.
Molecular information company Foundation Medicine (NasdaqGS:FMI) revealed on Friday the launch of a definitive agreement to develop a novel companion diagnostic assay
for Lynparza (olaparib) to support its global development programme in partnership with AstraZeneca.
Food and Drug Administration (FDA) approval of a new companion diagnostic assay
that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment.
The Company's diagnostic product portfolio consists of the first-ever validated microRNA diagnostic assay
for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, innovative genetic testing solutions for the fragile X mental retardation (FMR1) gene, Signature[R] Oncology products for the qualitative detection of gene translocations and mutations in a variety of hematological and solid tumors, RNA stabilization technologies, and industry-leading controls and standards engineered using its patented Armored RNA[R] technology.
M2 PHARMA-October 6, 2015-US FDA approves Dako's new companion diagnostic assay
for lung cancer
The new VENTANA ALK IHC companion diagnostic assay
brins a highly effective, standardized, and cost-efficient testing method to patients and lab professionals for the evaluation of ALK protein expression.
Fujirebio Diagnostics, a world leader in cancer diagnostics and biomarker assays, announced today it has acquired American Biological Technologies, the Seguin, Texas-based manufacturer of in vitro diagnostic assay
controls and calibrators.
Amarantus Diagnostics' MSPrecise neuroimmunology-based next-gen sequencing diagnostic assay
for multiple sclerosis offers a potentially highly accurate and actionable result that will substantially improve upon the high mis-diagnosis rate of this degenerative disease.
M2 PHARMA-October 5, 2015-Dako awarded US FDA approval for PD-L1 IHC 22C3 pharmDx diagnostic assay
for lung cancer