Gen-probe, Inc.

Theranos, Inc.

Life Technologies Corporation

Labrador Diagnostics LLC

Ventana Medical Systems, Inc.

Keith Moravick

Bruce J Richardson

David Opalsky

David A Buse

Norbert D Hagen

David Howard Combs

Tyler Moore

Anita Prasad

Byron J Knight

Elizabeth A Holmes

Ian Gibbons

Shaunak Roy

Edmond Ku

Chris Todd

Jeff Fenton

Anthony Delacruz

Bruce Johnson

Shize Daniel Qi

Melissa Takahashi

Uwe Springborn

Thomas Michael Baer

David P Moriconi

David F Head

Robert H Reamey

Jason F Rhubottom

Raphael Hebert

Derrick A Richardson

Gregory C Loney

Bruce Richardson

An apparatus for incubating the contents of a plurality of receptacles and for detecting a signal emitted by the contents of each of the receptacle includes a plurality of receptacle holders configured to incubate the contents of each a plurality of receptacles held by each of the receptacle holders. A controller is coupled to each of the receptacle holders and is configured to independently control an incubation temperature of each of the receptacle holders to independently control a temperature at which the receptacles held by each of the receptacle holders is incubated. At least one signal detector is configured to detect a signal emitted by the contents of each of the receptacles held in each of the receptacle holders, and a signal detector indexer is configured to successively optically couple each signal detector with each of the receptacles held in each of the receptacle holders to detect optical emissions from each successively coupled receptacle.

Apparatus for incubating receptacles and detecting optical signals emitted by the contents of the receptacles

An apparatus for performing nucleic acid amplification reactions includes a thermally-conductive receptacle holder that includes multiple receptacle wells. Each well can receive a receptacle and has a through-hole extending from an inner surface of the well to an outer surface of the holder. The apparatus includes multiple optical fibers, and each optical fiber has a first end in optical communication with an associated well and a second end in optical communication with an excitation signal source and/or an emission signal detector. The first end of each optical fiber is moveable with respect to the through-hole. A cover is movable between an open position and a closed position relative to the receptacle holder, and the first end of each optical fiber moves with respect to the through-hole of the associated well as the cover moves to the open or closed position or when the cover moves into or out of contact with any receptacles within the wells.

Apparatus for applying thermal energy to a receptacle and detecting an emission signal from the receptacle

A first time/temperature data set includes temperatures and time stamps recorded at time intervals during a first thermal cycling process and a time stamp for each time interval, and a second time/temperature data set includes temperatures and time stamps recorded at time intervals during a second thermal cycling process. Signal emissions at different signal detecting positions are sequentially measured at different time intervals to generate first and second time/signal emission data sets for receptacles subject to the first and second thermal cycling processes, respectively. Signal emissions of receptacles subject to the first thermal cycling process are synchronized with specific temperatures of the first thermal cycling process by comparing time stamps of the first time/signal emission data set for each receptacle with the time stamps of the first time/temperature data set that correspond with the specific temperature. Signal emissions of receptacles subject to the second thermal cycling process are synchronized with specific temperatures of the second thermal cycling process by comparing time stamps of the second time/signal emission data set for each receptacle with the time stamps of the second time/temperature data set that correspond with the specific temperature.

Determining temperature-varying signal emissions during automated, random-access thermal cycling processes

Multiple receptacles containing a reaction mixture are transported to corresponding receptacle wells of a thermally-conductive receptacle holder in thermal communication with a support that is in thermal communication with a heat sink. The heat sink is pre-heated to a temperature above ambient temperature, and the temperature of the receptacle holder is cycled. Optical communication is established between each of the receptacle wells and an excitation signal source and an emission signal detector during cycling, and whether an emission signal is emitted from any of the receptacles is determined as an indication of the presence of a target nucleic acid.

Method for applying thermal energy to a receptacle and detecting an emission signal from the receptacle

An apparatus for performing nucleic acid amplification reactions includes a thermally-conductive receptacle holder with front and back surfaces. The front surface includes a row of receptacle wells, and an outer surface of each well has a frustoconical shape, an inner surface of each well receives a receptacle, and each well has a through-hole extending between the inner and outer surfaces thereof. One or more thermal elements in contact with the back surface of the holder alter a temperature(s) of the holder. The apparatus includes multiple optical fibers, and each optical fiber provides optical communication between one of the wells and an excitation signal source and/or an emission signal detector. A first end of each optical fiber is disposed outside, within, or extends through the through-hole of a corresponding well, and a second end of each optical fiber is in optical communication with the excitation signal source and/or the emission signal detector.

An apparatus for performing nucleic acid amplification reactions includes a thermally-conductive receptacle holder with multiple receptacle wells. Each well has a through-hole extending from an inner surface of the well to an outer surface of the holder. A cover is rotatable between an open position and a closed position relative to the holder and is configured to exert a force onto any receptacles in the wells when the cover is in the closed position. The apparatus includes multiple optical fibers, and each of the optical fibers provides optical communication between one of the wells and an excitation signal source and/or an emission signal detector. A thermal element is positioned between a thermally-conductive support and the receptacle holder.

A method for performing a nucleic acid amplification assay employs a thermally-conductive receptacle holder with one or more receptacle wells, each conforming to an outer surface of a lower portion of a vial. A through-hole extends from an inner surface of each well to an outer surface of the holder. A thermal element is positioned proximal to the holder for altering a temperature of the holder. A signal detection module is configured to generate an excitation signal directed through the through-hole of the well and detect an optical emission from a fluid contained in the vial supported by the well. At least one well supports a capped vial containing a reagent for a nucleic acid amplification assay and including an opaque cap sealing an open end of the vial. The lower portion of the vial is contained within a well, and the cap is situated above a top surface of the holder.

Method for conducting an assay

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Systems and methods of sample processing and fluid control in a fluidic system

A system for performing a nucleic acid amplification assay that includes a receptacle holder formed from a thermally conductive material and having a receptacle well for receiving a lower portion of a vial; a thermal element for cycling the temperature of the receptacle holder; a signal detection module in optical communication with the receptacle well; and a robotic pipettor. The receptacle holder supports a capped vial having a plastic, opaque cap in a snap-fit with a single plastic vial containing a nucleic acid amplification reagent. An upper portion of the cap includes a probe recess that is configured to be removably engaged by an end of a probe of the robotic pipettor. A lower portion of the vial is contained within the receptacle well, and the cap is situated above a top surface of the receptacle holder.

System and method for conducting an assay

Receptacles containing a reaction mixture are transported to receptacle wells of a thermally conductive receptacle holder, and the temperature of the holder is cycled with a thermoelectric device situated between a support and a first side of the holder while a first force is applied onto a second side of the holder. Optical communication between each well and an excitation signal source and an emission signal detector is established to determine whether an emission signal is emitted from any of the receptacles during temperature cycling as an indication of the presence of a target nucleic acid. The thermoelectric device may be situated between an upright portion of the support and the first side of the holder. A second force may be applied onto a top end of each receptacle in the holder by a cover moveable with respect to the receptacles between an open position and a closed position.

A thermally conductive receptacle holder includes a plurality of wells that each receive a receptacle. A cross-brace is mounted to a support to exert a force onto an outer surface of a compressive housing such that the compressive housing exerts a force onto the receptacle holder. An optical fiber associated with each well provides optical communication between the receptacle well and an excitation signal source and/or an emission signal detector.

Apparatus for holding a receptacle and applying thermal energy to the receptacle

First and second sets of receptacles containing reagents for first and second amplification reactions, respectively, are placed in first and second receptacle holders, each associated with a thermal element. The receptacles are subjected to different first and second incubation processes resulting in the first and second amplification reactions in each of the first and second sets of receptacles that contain a first or a second target nucleic acid, respectively. The presence or absence of the first or second target nucleic acid, if any, is determined for each receptacle of the first and second sets of receptacles.

Method for simultaneously performing a plurality of different amplification reactions

System, apparatus, and method for cycling the temperature of at least one receptacle holder that is adapted for use in an automated instrument capable of performing nucleic acid-based amplification tests. Also provided are methods for conducting automated, random-access incubation processes using the same.

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Palo Alto, CA, United States of America

Keith Moravick