This product tests genomic DNA. DNA can be extracted from the following specimens:

1. 5cc of peripheral blood, bone marrow biopsy, or bone marrow aspirate anti-coagulated with heparin or EDTA; OR,
2. Minimum 5mm cube of tissue shipped frozen, at room temperature, or on ice in RPMI 1640; OR,
3. Formalin-fixed paraffin embedded tissue or slides.

United States Patent number 6,846,630 (licensed exclusively to Invivoscribe Technologies, Inc. and owned by Takara Bio, Inc.) governs testing for the FLT3 mutation within the United States or where importation of test results to the United States for clinical use is facilitated. No license is conveyed by purchase and sale of this product for any such United States related product use where compensation for test results is charged or where test results are utilized for patient diagnosis or prognosis or added to patient files. Instead, a separate license is required for any such use. These licenses contain significant restrictions and may not be available in all circumstances.

European Patent number 0959132 (licensed exclusively to Invivoscribe Technologies, Inc. and owned by Takara Bio, Inc.) governs testing for the FLT3 mutation within Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, The Netherlands, Portugal, Spain, Sweden and Switzerland. The same patent governs testing elsewhere where importation of test results into any of these listed European countries for clinical use is facilitated.

A patent license is required for any product use governed by European Patent 0959132 as described above, if (i) compensation for test results is charged or if (ii) test results are utilized for patient diagnosis or prognosis or added to patient files. Included with the purchase price of this kit when sold to purchasers located within any of the European countries listed above is a limited license to perform no more than fifteen (15) tests requiring a European Patent license. Concurrent testing of positive, negative and blank controls do not count towards this total. Issuance of this limited license is contingent upon (i) maintaining and making available on reasonable notice records that reasonably demonstrate number of patent covered tests performed, and (ii) including this information (in the language of the test report) in any test report form: “This test was performed pursuant to a license to European Patent 0959132, owned by Takara Bio Inc. of Otsu, Japan and licensed through Invivoscribe Technologies, Inc. of San Diego, USA.”

For patent related reasons, this FLT3 assay is not currently available for shipment to, or use in, Japan.

These methods also require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). No license to use the PCR process or associated enzymes is conveyed expressly or by implication by the purchase of these products.

For additional patent information, contact our legal department by email at legal@Invivoscribe.com, or by telephone in the United States: +1 (858) 224-6600.