Theranos, Inc.

Roche Diagnostics Operations, Inc.

Roche Diabetes Care, Inc.

Labrador Diagnostics LLC

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Theranos IP Company, LLC

Paul Patel

Elizabeth A Holmes

Ian Gibbons

Samartha Anekal

Hans List

Daniel L Young

Daniel ManHung Wong

Charles C Raney

Mark Dayel

Volker Zimmer

Joy Roy

Wolfgang Petrich

Chinmay Pangarkar

Edward P Perez

Uwe Kraemer

Gary Frenzel

Stephan-Michael Frey

John Kent Frankovich

Sunny Balwani

Alexander Loo

Christian Hoerauf

Adrit Lath

Michael Chen

Douglas Matje

Wolfgang Roedel

Timothy Smith

Swapna Joshi

Christian Vrancic

Gangakhedkar Surekha

Anekal Samartha

Reagents, assays, methods, kits, devices, and systems for rapid measurement of cholesterol and cholesterol sub-fractions from a blood sample are provided. Total cholesterol, low density lipoprotein cholesterol, and high density lipoprotein cholesterol can be measured in a single assay using kinetic measurements, under conditions in which cholesterol sub-species are converted to a detectable product at distinct rates. The detectable product is measured at different times after assay initiation. A lipase, cholesterol esterase, cholesterol oxidase and a peroxidase may be used together to produce colored product in amounts directly proportional to the quantity of cholesterol converted. Methods for calculating very-low density lipoprotein cholesterol levels by further including triglyceride measurements are disclosed. Assays may be performed in a single reaction mixture, allowing more accurate and precise cholesterol determinations, including ratios of cholesterol sub-fractions to total cholesterol, at less expense, than would be expected by performing several different assays in different reaction mixtures.

Rapid, low-sample-volume cholesterol and triglyceride assays

Compositions and methods for measuring coagulation parameters using very small volumes of blood are provided. Advantageously, the methods described herein can be performed from a single drop of blood (about 20 &#x3bc;L) while generally leaving enough sample to perform other measurements, optionally in a multiplexed format. The methods and devices do not require a skilled operator and can be performed at the point of service, which can be an important feature for managing blood coagulation disorders and treatments thereof.

Low-volume coagulation assay

Methods for improving assays of biological samples are provided, including assays of small volume biological samples, such as blood samples obtained from a fingerstick. The methods include steps of selecting a baseline assay; providing a first revised assay by altering an aspect, a reagent, or a step of the baseline assay; comparing the results of the baseline assay and first revised assay; and identifying the first revised assay as an improved assay if the results of the first revised assay are similar to, are substantially the same as, or are better than, the results of the baseline assay. The methods may be iterated. Alterations include reducing sample volume; setting temperature; reducing step number and duration; altering reagent composition and number; and altering detection. Improved assays may reduce the duration, cost, or complexity of the assay, may improve assay sensitivity, accuracy, or reliability, and may provide synergistic improvements.

Methods for improving assays of biological samples

Methods, compositions, systems, and devices are provided for performing and analyzing agglutination assays. In one aspect, methods for image analysis of agglutination assays are provided. In another aspects, methods for performing agglutination assays are provided. In one aspect, the methods may be used for the detection of various molecules, including viruses or antibodies against a virus. In another aspect, the methods can be used to determine effective immunization of a subject.

Methods for detecting and measuring aggregation

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Systems and methods for multi-analysis

Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Devices and methods for expression of bodily fluids from an incision

A system is proposed for detection of at least one analyte in a body fluid, in particular for detection of blood glucose. The system is designed to generate a sample of the body fluid and to transfer at least some of the sample to at least one test element, in particular a test panel. The system is designed such that a time period between the generation of the sample and the application to the test element is less than 1 second, preferably less than 500 ms.

Blood glucose measurement for small blood volume

Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip. The instrument has a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring surrounds a skin contact opening and is adapted for pressing against the skin such that the skin bulges into the opening for promoting expression of body fluid. The skin contact opening has an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm, and the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N and at most 8 N.

Instruments and system for producing a sample of a body fluid and for analysis thereof

Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Rapid blood expression and sampling

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Sunnyvale, CA, United States of America

Paul Patel