Variants of Uncertain Significance (VUS) are limiting the success of targeted therapies

Cancer research has established that tumorigenesis and tumor progression typically result from the accumulation of somatic genomic alterations over the life span of the tumor. Alterations that are integral to a tumor’s growth and survival are known as driver mutations; the others are known as passenger mutations. Mutations that are not yet characterized, VUS, may turn out to be driver mutations and, as such, may be translated to proteins that dysregulate signaling pathways (for example, actively promoting excessive replication, or inhibiting apoptosis).

Monitor the activity levels of the signaling pathways, analyze response to targeted therapies.

NGS reveals mutations, but provides no knowledge of whether the translated protein is actually aberrantly activated. This is because the functional significance of most mutations is uncertain, let alone that of networks of interacting proteins. NovellusDx monitors the activity level of signaling pathways that results from found mutations and tests how the activity responds to targeted therapies.

Fully automated, high-throughput, high-content live-cell screening straight from NGS data.

Once we receive the NGS data, we resynthesize the genes with all the mutations - driver, passenger and VUS - and express them in a cell-line. After an incubation period, the cells are scanned in a high-content microscopy system and analyzed using our proprietary algorithms to determine the localization of specific downstream reporters inside the cells. This tells us the activity level of each signaling pathway. We then repeat the process with the incubation of targeted therapies which allows us to assess drug response.

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Physician sends NovellusDx NGS data or fresh biopsy

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Patient tailored fluorescent live-cell chip is printed on slides

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Automatic high content image analysis of signaling pathways activation

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Results and data integration to actionable report for the physicians

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Physician sends NovellusDx NGS data or fresh biopsy

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Patient tailored fluorescent live-cell chip is printed on slides

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Automatic high content image analysis of signaling pathways activation

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Repeat process with targeted drugs and drug combination testing

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Results and data integration to actionable report for the physicians


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Repeat process with targeted drugs and drug combination testing

For Oncologist

NovellusDx provides clinicians and patients functional information to supplement their genomic data and tests targeted therapies efficacy on their specific genomic profiles.

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For BioPharma

NovellusDx is the trusted partner for BioPharma, providing services and support for functional genomic informed oncology drug development and commercialization.

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FAQ

WHAT CELL-LINES DO YOU USE?

We use a highly controlled HeLa cell-line. By transfecting groups of cells with WT and known driver mutations we remove all cell-line specific background activity.

 

 

IS THIS AN EXPRESSION ASSAY?

No. We don’t monitor the expression levels of the genes but rather monitor their effect on the localization of specific downstream proteins that constitute the signaling pathway.

WHAT IS YOUR TURNAROUND TIME?

Our turnaround time is about 14 days.

WHAT DO I NEED TO SEND YOU? DO I NEED TO SEND YOU THE BIOPSY?

The only thing we need is the NGS data, any format is acceptable. We will synthesize the mutated genes and test them.

WHICH DRUGS CAN YOU TEST?

We test most existing targeted therapies (see list below) and we are excited about working on new drug candidates.

Ado-trastuzumab emtansine (Kadcyla), Afatinib (Gilotrif), Alectinib (Alecensa), Axitinib (Inlyta), Buparlisib, Cabozantinib, Ceritinib (Zykadia), Cetuximab (Erbitux), Cobimetinib (Cotellic), Crizotinib (Xalkori), Dabrafenib (Tafinlar), Dactolisib (Investigational Drug), Erlotinib (Tarceva), Everolimus (Afinitor), Foretinib (Investigational Drug), Gefitinib (Iressa), Herceptin (Trastuzumab), Idelalisib (Zydelig), Imatinib (Gleevec), Lapatinib (Tykerb), Lestaurtinib, Necitumumab (Portrazza), Neratinib, Osimertinib (Tagrisso), Pacritinib, Panitumumab (Vectibix), Pazopanib (Votrient), Ponatinib (Iclusig), Regorafenib (Stivarga), Selumetinib, Sorafenib (Nexavar), Sunitinib (Sutent), Temsirolimus (Torisel), Tivantinib, Trametinib (Mekinist), Vemurafenib (Zelboraf)

WHAT TYPE OF REGULATORY APPROVAL DO YOU HAVE?

Our lab is both CMS and CLIA certified. In November 2015, the lab received ISO 13485:2003 for the “development of diagnostic solutions for personalized medicine”. This allows us to serve patients from the US and internationally.