The US Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific’s blood test for detecting systemic lupus erythematosus (SLE), the most common kind of lupus.
The EliA SmDP-S test can boost specificity without compromising on sensitivity, offering accurate diagnoses and lowering the number of false positives.
It leverages an innovative coating technique streamlined for attaching the synthetic SmD₃ peptide antigen, which has the most specific epitope for Sm peptide antibodies.
Thermo Fisher noted that the antibodies which react with the SmD₃ peptide do not cross-react with other Sm peptides, thereby enhancing the specificity of the test for differentiating SLE from mixed connective tissue disease (MCTD).
The US FDA also granted pre-market approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to detect patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA).
CCA is a rare, aggressive cancer of the bile ducts both inside and outside of the liver.
The next-generation sequencing (NGS)-based test is intended to be used in IDH1 patients who may require treatment with Servier Pharmaceuticals’ Tibsovo (ivosidenib tablets).
An IDH1 inhibitor, Tibsovo is indicated for treating adult patients with already treated, locally advanced or metastatic CCA with an IDH1 mutation.
The Oncomine Dx Target Test offers strong and reproducible results in the IDH1 gene clinically linked to CCA.
In 2017, the test initially received approval from the FDA as a CDx and it is currently approved for four targeted treatments for non-small cell lung cancer (NSCLC) and one targeted therapy for CCA in the US.
Thermo Fisher Scientific clinical NGS and oncology president Garret Hampton said: “With the FDA approval of Oncomine Dx Target Test as a companion diagnostic for Tibsovo, healthcare providers across the US can now match patients with this critically needed therapy.
“Advances in genetic profiling through NGS have enabled identification of an increasing number of cancer-driving genomic variations, opening the door for the development of more targeted treatment options.”
Currently, the test is approved in more than 15 countries, including the US, Japan and South Korea as well as certain countries in Europe and the Middle East.
Last week, Thermo Fisher Scientific received emergency use authorization (EUA) from the FDA for two of its next-generation Covid-19 assays.