Abstract: Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer. In some embodiments, the disclosure provides improved prostate antigen standards for quantifying levels of prostate antigens.

Abstract: Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer.

Abstract: Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer.

Abstract: Aspects of the disclosure relate to improved methods and systems for active surveillance of subject having non-aggressive prostate cancer.

Abstract: Systems and methods for analysis of samples, and in certain embodiments, microfluidic sample analyzers configured to receive a cassette containing a sample therein to perform an analysis of the sample are described. The microfluidic sample analyzers may be used to control fluid flow, mixing, and sample analysis in a variety of microfluidic systems such as microfluidic point-of-care diagnostic platforms. Advantageously, the microfluidic sample analyzers may be, in some embodiments, inexpensive, reduced in size compared to conventional bench top systems, and simple to use. Cassettes that can operate with the sample analyzers are also described.

Abstract: Fluidic devices and methods are provided.

Abstract: Articles and methods for preparing a surface for obtaining a patient sample, such as blood, are generally provided. In some embodiments, the methods involve wiping a surface of skin of a patient in preparation for obtaining a sample (e.g., a blood sample) from the patient. In some embodiments, the methods involve wiping the surface of the skin with two or more wipes. For instance, the surface of the skin may be wiped with a first wipe comprising a surfactant and a second wipe comprising an antiseptic solution. Advantageously, the use of a first wipe including a surfactant followed by a second wipe may remove a higher amount of certain contaminants (e.g., proteins, bacteria, viruses) from the surface of the skin as compared to the use of a single wipe or by hand-washing alone.

Abstract: The specification generally discloses systems and methods for mixing and delivering fluids in microfluidic systems. The fluids can contain, in some embodiments reagents that can participate in one or more chemical or biological reactions. Some embodiments relate to systems and methods employing one or more vent valves to controllably flow and/or mix portions of fluid within the microfluidic system. Advantageously, fluid control such as a sequence of fluid flow and/or a change in flow rate, can be achieved by opening and closing one or more vent valves and by applying a single source of fluid flow (e.g., a vacuum) operated at a substantially constant pressure. This can simplify the operation and use of the device by an intended user.

Abstract: Articles and methods for collecting and/or facilitating transfer of fluids are generally provided. In some embodiments, an article comprises a fluid collection region for introducing a fluid, such as a sample (e.g., blood sample) or a reagent, into a fluidic system. The articles and methods described herein may be useful for facilitating the filling of relatively small channels with a fluid, such as channels of a microfluidic device. The articles and methods may, for example, interface with a patient sample (e.g., a droplet of blood), or with a macroscopic fluid source such as a pipette or syringe. In certain embodiments, articles and methods described herein may increase the ease of collecting a fluidic sample from a patient, prevent or reduce spillage of the fluidic sample, reduce contamination of a fluidic sample, and/or prevent or reduce air from entering a fluidic sample or device compared to certain existing fluid collection devices.

Abstract: Fluidic devices and methods involving incubation and/or mixing of assay components are provided. In some embodiments, a biological and/or chemical assay may be performed in a fluidic device. The fluidic device may be designed to allow for controlled incubation and/or mixing of two or more assay components. In some such embodiments, the fluidic device may comprise an incubation channel having a relatively large cross-sectional dimension in fluid communication with a detection channel. The incubation channel may allow for adequate mixing and/or incubation of two or more assay components prior to analysis of the assay. In some embodiments, fluidic devices for performing a vitamin D assay are provided.

Abstract: Articles and methods for collecting and/or facilitating transfer of fluids are generally provided. In some embodiments, an article comprises a fluid collection region for introducing a fluid, such as a sample (e.g., blood sample) or a reagent, into a fluidic system. The articles and methods described herein may be useful for facilitating the filling of relatively small channels with a fluid, such as channels of a microfluidic device. The articles and methods may, for example, interface with a patient sample (e.g., a droplet of blood), or with a macroscopic fluid source such as a pipette or syringe. In certain embodiments, articles and methods described herein may increase the ease of collecting a fluidic sample from a patient, prevent or reduce spillage of the fluidic sample, reduce contamination of a fluidic sample, and/or prevent or reduce air from entering a fluidic sample or device compared to certain existing fluid collection devices.

Abstract: Fluidic connectors, methods, and devices for performing analyses (e.g., immunoassays) in microfluidic systems are provided. In some embodiments, a fluidic connector having a fluid path is used to connect two independent channels formed in a substrate so as to allow fluid communication between the two independent channels. One or both of the independent channels may be pre-filled with reagents (e.g., antibody solutions, washing buffers and amplification reagents), which can be used to perform the analysis. These reagents may be stored in the channels of the substrate for long periods amounts of time (e.g., 1 year) prior to use.

Abstract: Fluidic devices and methods associated with mixing of fluids in fluidic devices are provided. In some embodiments, a method may involve the mixing of two or more fluids in a channel segment of a fluidic device. The fluids may be in the form of, for example, at least first, second and third fluid plugs, composed of first, second, and third fluids, respectively. The second fluid may be immiscible with the first and third fluids. In certain embodiments, the fluid plugs may be flowed in series in the channel segment, e.g., in linear order, causing the first and third fluids to mix without the use of active components such as mixers. The mixing of fluids in a channel segment as described herein may allow for improved performance and simplification in the design and operations of fluidic devices that rely on mixing of fluids.

Abstract: Methods and apparatuses for conducting analyses are provided.

Abstract: Fluidic devices and methods including those that provide storage and/or facilitate fluid handling of reagents are provided. Fluidic devices described herein may include channel segments positioned on two sides of an article, optionally connected by an intervening channel passing through the article. The channel segments may be used to store reagents in the device prior to first use by an end user. The stored reagents may include fluid plugs positioned in linear order so that during use, as fluids flow to a reaction site, they are delivered in a predetermined sequence. The specific geometries of the channel segments and the positions of the channel segments within the fluidic devices described herein may allow fluid reagents to be stored for extended periods of time without mixing, even during routine handling of the devices such as during shipping of the devices, and when the devices are subjected to physical shock or vibration.

Abstract: Systems and methods for analysis of samples, and in certain embodiments, microfluidic sample analyzers configured to receive a cassette containing a sample therein to perform an analysis of the sample are described. The microfluidic sample analyzers may be used to control fluid flow, mixing, and sample analysis in a variety of microfluidic systems such as microfluidic point-of-care diagnostic platforms. Advantageously, the microfluidic sample analyzers may be, in some embodiments, inexpensive, reduced in size compared to conventional bench top systems, and simple to use. Cassettes that can operate with the sample analyzers are also described.

Abstract: Fluidic devices and methods are provided.

Abstract: Systems and methods for analysis of samples, and in certain embodiments, microfluidic sample analyzers configured to receive a cassette containing a sample therein to perform an analysis of the sample are described. The microfluidic sample analyzers may be used to control fluid flow, mixing, and sample analysis in a variety of microfluidic systems such as microfluidic point-of-care diagnostic platforms. Advantageously, the microfluidic sample analyzers may be, in some embodiments, inexpensive, reduced in size compared to conventional bench top systems, and simple to use. Cassettes that can operate with the sample analyzers are also described.

Abstract: The specification generally discloses systems and methods for mixing and delivering fluids in microfluidic systems. The fluids can contain, in some embodiments reagents that can participate in one or more chemical or biological reactions.

Abstract: Fluidic connectors, methods, and devices for performing analyses (e.g., immunoassays) in microfluidic systems are provided. In some embodiments, a fluidic connector having a fluid path is used to connect two independent channels formed in a substrate so as to allow fluid communication between the two independent channels. One or both of the independent channels may be pre-filled with reagents (e.g., antibody solutions, washing buffers and amplification reagents), which can be used to perform the analysis. These reagents may be stored in the channels of the substrate for long periods amounts of time (e.g., 1 year) prior to use.