Exact Sciences has developed a reagent mixture for detecting specific mutant copies of the KRAS gene, including 34A, 34C, 34T, 35A, 35C, 35T, and 38A mutations. The mixture includes multiplexed amplification and flap assay reagents, enabling detection in a single reaction. GlobalData’s report on Exact Sciences gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Exact Sciences, Personalized medicine biomarkers was a key innovation area identified from patents. Exact Sciences's grant share as of July 2024 was 44%. Grant share is based on the ratio of number of grants to total number of patents.

Kras gene mutation detection reagent mixture and methods

Source: United States Patent and Trademark Office (USPTO). Credit: Exact Sciences Corp

The patent US12060620B2 describes a reagent mixture designed for the amplification and detection of specific point mutations in the KRAS gene, which are significant in various cancers. The mixture includes amplification reagents such as a thermostable polymerase, nucleotides, and a set of at least seven forward primers, each targeting different point mutations (34A, 34C, 34T, 35A, 35C, 35T, and 38A) in the KRAS gene. Each forward primer is engineered to be complementary to the KRAS gene sequence, with a single base mismatch near the 3' terminal nucleotide, allowing for selective amplification of mutant alleles. Additionally, the mixture incorporates flap assay reagents, including a flap endonuclease and two distinguishable FRET cassettes that emit different fluorescent signals upon cleavage, facilitating the detection of the amplified mutations.

Furthermore, the patent outlines the composition of a kit that includes these reagents, which can also amplify and detect a control sequence from a gene other than KRAS, such as the ß-actin gene. The kit is designed to work effectively even in samples with a high excess of wild-type KRAS gene copies, ensuring the detection of mutant copies. The FRET cassettes are specified to include sequences that enhance the assay's sensitivity and specificity. This innovative reagent mixture and kit provide a valuable tool for researchers and clinicians in the detection of KRAS mutations, which are critical for understanding cancer biology and guiding treatment decisions.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies across the world’s largest industries.