Oncomine Precision Assay receives breakthrough Apparatus designation from the U.S FDA

Oncomine Precision Assay receives breakthrough Apparatus designation from the U.S FDA


  • Post By : Kumar Jeetendra

  • Source: Microbioz India

  • Date: 30 Jun,2020

Thermo Fisher recently expanded its strategic partnership arrangement with Agios Pharmaceuticals into co-develop the company diagnostic (CDx) to get vorasidenib, an investigational, oral, brain-penetrant, double inhibitor of mutant IDH1 and IDH2 enzymes now under examination at the Stage 3 INDIGO research for IDH mutant LGG. As time passes, Thermo Fisher attempts to get premarket approval (PMA) for its Oncomine Precision Assay for a companion diagnostic for numerous treatments, in addition to approval for fluid biopsy tumor profiling in lung cancer and strong tissue tumor profiling in several cancer types.

In November 2019, the Oncomine Precision assay was initially introduced as a study product to operate on Ion Torrent Genexus System –the world’s first completely automatic next-generation sequencing (NGS) system using a specimen-to-report workflow which produces comprehensive genomic profiling leads to a single moment.

Mr. Amit Chopra, managing director, India and Middle East,” Thermo Fisher Scientific, stated”Quick accessibility to detailed genomic profiling information will open a whole lot of chances to research accurate therapy choices in the present treatment regimes. The multi-biomarker profiling that’s generated on site and available in roughly a day is game-changing for health care professionals, by hastening their evaluation and prescribe the most appropriate treatment for their patients quicker than previously.”

“We’ve taken a fantastic step ahead by equipping the healthcare sector with quicker access to detailed genomic data, which illustrates our Mission to empower our clients to make the world healthier, safer and cleaner.” He included.

The Ion Torrent Genexus System is the primary turnkey next-generation sequencing (NGS) solution that simplifies the specimen-to-report workflow and provides results in one day with two consumer touch points. The Oncomine Precision Assay about the Ion Torrent Genexus System is a next-generation genomic profiling alternative that may permit every lab to deliver a genomic profile using a one time, hands-free workflow.

When coupled with all the Genexus System, molecular testing labs can create extensive NGS results within precisely the exact same interval as single-gene tests. Furthermore, these characteristics set the platform for molecular pathologists from the long run to analyze NGS info in parallel using first-line testing methods, such as immunohistochemistry (IHC).

Using its unprecedented rate to outcomes, the Genexus System is set to accelerate a wide array of program areas, such as oncology, infectious disease, inherited disorder and reproductive health, amongst others. Since its launching in November 2019 as a study sole option, the integrated sequencer has also been permitted to examine SARS-CoV-2 samples to encourage epidemiology or contact tracing studies.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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