Waltham, MA, United States
Waltham, MA, United States

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A biochip for the integration of all steps in a complex process from the insertion of a sample to the generation of a result, performed without operator intervention includes microfluidic and macrofluidic features that are acted on by instrument subsystems in a series of scripted processing steps. Methods for fabricating these complex biochips of high feature density by injection molding are also provided.


Patent
NetBio, Inc. | Date: 2015-01-13

Plastic electrophoresis separation chips are provided comprising a plurality of microfluidic channels and a detection window, where the detection window comprises a thin plastic; and the detection window comprises a detection region of each microfluidic channel. Such chips can be bonded to a support provided an aperture is provided in the support to allow detection of samples in the electrophoresis chip at the thin plastic detection window. Further, methods for electrophoretically separating and detecting a plurality of samples on the plastic electrophoresis separation chip are described.


In an apparatus that comprises a test module holder (20), an electrophoresis device (30) and a fluorescence xcitation and detection system (40), a processor is equipped with a lanefinding software for optically determining the positions of the separation channels (110) of the test module (55).


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 3.00M | Year: 2012

DESCRIPTION (provided by applicant): Improved diagnosis of Chlamydia trachomatis (Ct) infections represents a critical unmet medical need. Ct is the most common cause of bacterial sexually transmitted diseases (STD) worldwide, and the Centers for Disease Control and Prevention estimate that there are 2.8 million US cases annually. Currently, 40% of women with untreated infection will develop pelvic inflammatory disease (PID), 20% of whom will become infertile, 18% will experience debilitating, chronic pelvic pain, and 9% will have a life-threatenig ectopic pregnancy. If an infected pregnant woman is not treated, her baby has a 50% chance of developing conjunctivitis and a 20% chance of pneumonia in the first six months of life. Ct is also a risk factor for invasive squamous-cell carcinoma of the cervix and a complicating factor in HIV-1 infection and transmission. In males, the clinical presentation includes proctitis, genital ulcer and/or inguinal lymphadenopathy. The main obstacle to stemming this epidemicis the lack of an inexpensive nucleic acid-based point-of-care (POC) diagnostic for screening. Current chlamydial diagnostics are primarily based on nucleic acid amplification tests (NAAT) that lack concordance across the different NAATs, vary in sensitivity (although specificity is high), are expensive, require technical expertise, take days for results, and cannot be performed at the POC. They are also unable to differentiate between invasive lymphogranuloma venereum (LGV) versus non-invasive strains, the former of which require weeks of antibiotic therapy for eradication. Our overall SBIR goal is to develop a rapid, cost-effective, sensitive and specific Ct POC diagnostic system to increase early detection, inform appropriate treatment, reduce the rateof infections, and thereby reduce sequelae. In SBIR Phase I, we developed an initial microfluidic NAAT and demonstrated that its sensitivity and specificity are superior to those of a commercial NAAT. In SBIR Phase II, we propose to: 1) Optimize our assaybased on information gained by whole genome sequencing clinical Ct strains; 2) incorporate all assay processes in an easy-to operate breadboard instrument; and 3) do a head-to-head comparison of the optimized system against two commercially available assays. Given the genomic expertise of Dr. Tim Read and the chlamydial STD expertise of Dr. Dean, and the molecular biological and microfluidic expertise of Dr. Selden, the application provides a unique collaborative opportunity to finally obtain a rapid nucleic-acid based POC diagnostic for C. trachomatis. PUBLIC HEALTH RELEVANCE: Chlamydia trachomatis is the leading bacterial cause of sexually transmitted diseases in the US. Many of these infections are asymptomatic and go undetected, which leads toincreased transmission and the sequelae of pelvic inflammatory disease, infertility and ectopic pregnancy. Current diagnostics require extensive technical expertise, are expensive and take days for results, leading to loss of follow up. NetBio is developing an easy to use, cost effective diagnostic that detects C. trachomatis within one hour at the point-of-care.


The invention provides methods and systems for ruggedizing a nucleic acid analyzing apparatus. The ruggedized apparatus can be used reliably and effectively in uncontrolled environments, such as, for example at a crime scene to collect and analyze forensic data, as well as in semi-controlled environments, such as, for example at a point of care location.


Patent
NetBio, Inc. | Date: 2015-06-02

A self-contained apparatus for isolating nucleic acid, cell lysates and cell suspensions from unprocessed samples apparatus, to be used with an instrument, includes at least one input, and: (i) a macrofluidic component, including a chamber for receiving an unprocessed sample from a collection device and at least one filled liquid purification reagent storage reservoir; and (ii) a microfluidic component in communication with the macrofluidic component through at least one microfluidic element, the microfluidic component further comprising at least one nucleic acid purification matrix; and (iii) at least one interface port to a drive mechanism on the instrument for driving said liquid purification reagent, through the microfluidic element and the nucleic acid purification matrix, wherein the only inputs to the apparatus are through the chamber and the interface port to the drive mechanism.


The invention provides methods and systems for ruggedizing a nucleic acid analyzing apparatus. The ruggedized apparatus can be used reliably and effectively in uncontrolled environments, such as, for example at a crime scene to collect and analyze forensic data, as well as in semi-controlled environments, such as, for example at a point of care location.


Patent
NetBio, Inc. | Date: 2016-06-15

Plastic electrophoresis separation chips are provided comprising a plurality of microfluidic channels and a detection window, where the detection window comprises a thin plastic; and the detection window comprises a detection region of each microfluidic channel. Such chips can be bonded to a support provided an aperture is provided in the support to allow detection of samples in the electrophoresis chip at the thin plastic detection window. Further, methods for electrophoretically separating and detecting a plurality of samples on the plastic electrophoresis separation chip described.


A biochip for the integration of all steps in a complex process from the insertion of a sample to the generation of a result, performed without operator intervention includes microfluidic and macrofluidic features that are acted on by instrument subsystems in a series of scripted processing steps. Methods for fabricating these complex biochips of high feature density by injection molding are also provided.


A biochip for the integration of all steps in a complex process from the insertion of a sample to the generation of a result, performed without operator intervention includes microfluidic and macrofluidic features that are acted on by instrument subsystems in a series of scripted processing steps. Methods for fabricating these complex biochips of high feature density by injection molding are also provided.

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