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IP Watch: BioFire Diagnostics, SpeeDx, IntegenX, Life Technologies, Stanford Among US Patent Winners

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SpeeDx of Eveleigh, Australia, has been awarded US Patent No. 8,394,946, "Multicomponent nucleic acid enzymes and methods for their use."

Alison Todd, Donald Birkett, Tram Doan, and Elisa Mokany are named as inventors.

Relates to multicomponent nucleic acid enzymes, or MNAzymes, and methods for their use. MNAzymes comprise two or more oligonucleotide components that self-assemble in the presence of one or more MNAzyme assembly facilitator molecules to form a catalytically active structure. The patent provides compositions for making MNAzymes and collections of MNAzymes. The patent also provides methods for using MNAzymes to detect, identify, and/or quantify one or more targets. The methods can be practiced in solution-based assays or in assays where one or more reaction components are attached to a support structure. The methods allow for multiplexing the MNAzyme detection to detect multiple targets in a single reaction. The patent also provides kits for making the compositions and for practicing the described methods.


Medical Diagnostic Laboratories has been awarded US Patent No. 8,394,936, "Methods and compositions for detecting serotypes of Chlamydia trachomatis capable of causing lymphogranuloma venereum."

Jason Trama, Eli Mordechai, and Martin Adelson are named as inventors.

Discloses methods and compositions for conducting PCR assays on samples to detect serotypes of Chlamydia trachomatis capable of causing lymphogranuloma venereum, or LGV. The assays take advantage of a deletion occurring in the cytotoxin gene locus specific to the L I, L II, and L serotypes. Each of the assays employs a first primer having a nucleotide sequence flanking one side of the deletion point and a second primer having a nucleotide sequence flanking the other side of the deletion point, wherein the first and second primers are capable of hybridizing respectively to the plus and minus strands of the Chlamydia trachomatis genome during PCR. Synthesis during the PCR of a sequence-specific amplicon containing this deletion point indicates that the sample contains nucleic acid specific to an LGV-causing serotype of Chlamydia trachomatis.


IntegenX has been awarded US Patent No. 8,394,642, "Universal sample preparation system and use in an integrated analysis system."

Stevan Jovanovich, William Nielsen, David Cohen, Michael Recknor, Mattias Vangbo, Ezra Van Gelder, Lars Majlof, and Omar El-Sissi are named as inventors.

Provides a system that can process a raw biological sample, perform a biochemical reaction, and provide an analysis readout. For example, the system can extract DNA from a swab, amplify short tandem repeat loci from the DNA, and analyze the amplified loci and STR markers in the sample. The system integrates these functions by using microfluidic components to connect what can be macrofluidic function. In one embodiment the system includes a sample purification module, a reaction module, a post-reaction clean-up module, a capillary electrophoresis module, and a computer. In certain embodiments, the system includes a disposable cartridge for performing analyte capture. The cartridge can comprise a fluidic manifold having macrofluidic chambers mated with microfluidic chips that route the liquids between chambers. The system fits within an enclosure of no more than 10 ft3, and can be closed, portable, and/or battery operated. The system can be used to go from raw sample to analysis in less than four hours.


Life Technologies has been awarded US Patent No. 8,394,609, "Primers and methods for the detection and discrimination of nucleic acids."

Irina Nazarenko, Ayoub Rashtchian, Joseph Solus, Richard Pires, Marlene Darfler, Gulilat Gebeyehu, and Mekbib Astatke are named as inventors.

Provides novel primers and methods for the detection of specific nucleic acid sequences. The primers and methods are useful in a wide variety of molecular biology applications and are particularly useful in allele-specific PCR, the patent abstract states.

Life Technologies has also been awarded US Patent No. 8,394,585, "DNA methylation detection methods."

Shoulian Dong and Junko Stevens are named as inventors.

Provides DNA methylation quantification methods that avoid bisulfite treatment of DNA. Methylation-specific binding proteins (MeDNA binding proteins) and non-methylation specific binding proteins (non-MeDNA binding proteins) are employed in various embodiments to modulate the accessibility of nucleic acids to primer extension reactions. After selectively removing the target nucleic acids, the extension products can be analyzed and methylation quantitated. In some embodiments, the analysis comprises real-time PCR.


BioFire Diagnostics has been awarded US Patent No. 8,394,608, "Self-contained biological analysis."

Kirk Ririe, Michael Newswander, Randy Rasmussen, Mark Poritz, Stewart Smith, David Jones, and Gary Kessler are named as inventors.

Provides devices, containers, and methods for performing biological analysis in a closed environment. Illustrative biological analyses include nucleic acid amplification and detection and immuno-PCR.


Wako Pure Chemical Industries of Tokyo has been awarded US Patent No. 8,394,324, "Microchip large-volume PCR with integrated real-time CE detection."

Luc Bousse and Jian-ping Zhang are named as inventors.

Describes a microfluidic device with appropriate integrated structures to conduct large-volume PCR and end-point or real-time capillary electrophoresis detection. The microfluidic device includes a substrate having an amplification chamber of a volume of nucleic acid, wells disposed on the substrate, flow channels connecting the wells and the chamber and enabling solution flow through the chamber, and one or more separation channels connected to the chamber for separating and detecting a fraction of the amplified nucleic acid. The chamber, the flow channels, and the one or more separation channels are configured such that the hydrodynamic flow resistance of the chambers and the flow channels combined is at least 103 times smaller than the hydrodynamic flow resistance in the one or more separation channels. The microfluidic device can achieve a very high detection sensitivity while being highly cost effective, the patent's abstract states.


Stanford University has been awarded US Patent No. 8,394,251, "Control of chemical reactions using isotachophoresis."

Juan Santiago and Alexandre Persat are named as inventors.

Isotachophoresis, or ITP, is exploited to control various aspects of chemical reactions. In a first aspect, at least one of the reactants of a chemical reaction is confined to an ITP zone, but the resulting product of the reaction is separated from this zone by the ITP process. In a second aspect, one or more reactants of a reaction are confined to an ITP zone, and one or more other reactants of are not confined to this zone. In a third aspect, ITP is employed to confine at least one reactant of a chemical reaction to an ITP zone, and at least one reactant is delivered to the ITP zone in two or more discrete doses. These aspects are especially relevant to performing PCR using chemical denaturants as opposed to thermal cycling, the patent abstract states.

The Scan

Review of Approval Process

Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug.

Not Quite Right

A new analysis has found hundreds of studies with incorrect nucleotide sequences reported in their methods, according to Nature News.

CRISPR and mRNA Together

Time magazine reports on the use of mRNA to deliver CRISPR machinery.

Nature Papers Present Smartphone Platform for DNA Diagnosis of Malaria, Mouse Lines for Epigenomic Editing

In Nature this week: a low-cost tool to detect infectious diseases like malaria, and more.