WO2002064826A2 - Network for evaluating data obtained in a biochip measurement device - Google Patents
Network for evaluating data obtained in a biochip measurement device Download PDFInfo
- Publication number
- WO2002064826A2 WO2002064826A2 PCT/EP2002/001565 EP0201565W WO02064826A2 WO 2002064826 A2 WO2002064826 A2 WO 2002064826A2 EP 0201565 W EP0201565 W EP 0201565W WO 02064826 A2 WO02064826 A2 WO 02064826A2
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- WO
- WIPO (PCT)
- Prior art keywords
- point
- data
- care
- patient
- diagnostic
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Classifications
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16B50/00—ICT programming tools or database systems specially adapted for bioinformatics
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16B40/00—ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
- G16B40/20—Supervised data analysis
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16B40/00—ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
Definitions
- the present invention is directed to an arrangement for reading and evaluating data from a biosensor array (biochip) for medical diagnostic purposes.
- biomolecules such as a particular protein, antibody or DNA fragment
- a medical diagnosis based on identification of the presence of these biomolecules.
- the relevant biomolecule is referred to as a diagnostic marker for the' pathology.
- the pathological reaction chain is very complex, and involves a large number of different biomolecules which, in turn, also may play a role in the pathophysiology of another disease.
- a single marker is not always sufficient in order to unequivocally diagnose a particular disease. Often, it is only through an evaluation protocol involving several combined markers that a diagnosis can be made. For example, if a concentration is high for a first marker, low for a second marker, and a third marker is absent, then a particular disease can be diagnosed.
- the measurement of single markers or multiple markers is referred to as an in vitro diagnostic test.
- the development of markers for such diagnostic tests is very cost intensive and time intensive, and the development of expert rules for such tests is even more cost intensive and time intensive.
- the establishment of a marker rule or a multi-marker rule requires a procedure known as a clinical test or clinical study (sometimes merely called a "clini- cal").
- the clinical study includes measuring candidate markers in a large number of patients, usually hundreds to thousands of patients. From such data, a diagnosis standard is established, which will always have a certain error associated therewith. In order to determine whether the error is within an acceptable range, as well as to determine whether refinements or modifications in the standard reduces the error, it is necessary to retrospectively correct results which are ⁇ predicted" by the standard with actual follow-up examinations of the patients.
- the results from such a clinical study are the basis for approval of such a diagnostic test by a national authority, such as the FDA in the United States .
- the above object is achieved in accordance with the principles of the present invention in a network and a method for collecting data and diagnostic testing wherein a biochip with a multi-marker diagnostic test is employed.
- the biochip has a marker array, which can include *hidden" markers in addition to approved markers, the N hidden" markers not being used for making a current diagnostic decision with the approved markers.
- EPR electronic patient record
- a central data s s: Hi ⁇ ⁇ ⁇ -3 o pu pu H ⁇ pu rt O O ⁇ - ⁇ -3 cn J ⁇ a tr i ) rt a a rt rt 3 3 ⁇ - ⁇ rt ⁇ tr ⁇ - ⁇ - ⁇ -1 ⁇ ⁇ - tr tr a P ⁇ i- 13- ⁇ Hi a a tr pu O O pu pu a ⁇ i i ET ⁇ i ⁇ a ⁇ - tr a pu r+ rr ⁇ ft ⁇ - rt ⁇ ⁇ ⁇ - ⁇ rt ⁇ 3 a P " ⁇ Q a l- 1 H
- FIG 1 shows the basic steps and components in the method and network of the invention.
- FIG. 2 is a flowchart of an exemplary information exchange procedure in accordance with the invention.
- the present invention makes use of currently available biosensor arrays (biochips) and Electronic Patient Records (EPR) .
- biosensor arrays A new generation of biosensor arrays has been developed and is about to enter widespread use in the medical diagnostic market. Instead of conducting multiple measurements of multiple markers with a number of different devices, or using highly sophisticated robots in a centralized diagnostic laboratory, the new generation of biosensor arrays are able to measure, in a fully automated manner, a large number of markers simultaneously, up to thousands of different markers on the same chip, without a need for further human interaction. Moreover, such measurement are made outside of a formal laboratory environment. Almost all known types of biomolecular markers (e.g. DNA fragments, proteins, enzymes, antibodies, etc.) can be measured simultaneously on the same chip.
- biomolecular markers e.g. DNA fragments, proteins, enzymes, antibodies, etc.
- biochips are particularly suited for immediately conducting the diagnostic test at a point of care (POC) site, such as a hospital bedside, a physician's office, or even at the patient's home.
- POC point of care
- Such biochips also, of course, can be used in a professional centralized laboratory.
- a well documented trend in healthcare systems is the increasing establishment and use of electronic patient records, i.e., electronic media wherein all medically relevant information for a particular patient are stored. Such information can include, for example, diagnoses, measurement results, x- ray images or other medical images, records of therapeutic actions taken, surgical interventions, vaccinations, prescribed medications, etc.
- the data can be stored at distributed locations, usually at the site where the data or infor- mation was created or entered. With increasing access to the Internet, there is a known trend to connect such distributed sites for EPRs via a central server, which regulates access rights to the data relating to respective patients.
- the present invention makes use of such biosensor arrays and EPRs to allow data to be collected, and to allow expert rules to be optimized, in the context of a clinical study with the goal of obtaining regulatory approval, such as through the FDA.
- the inventive apparatus includes a biochip measurement device, for use with a number of multi-parameter biochips .
- a biochip measurement device for use with a number of multi-parameter biochips .
- an EPR segment 1 containing biochip data is produced for each of a number of patients (patient 1, patient 2, patient 3, etc.) .
- the apparatus also includes a user interface for entering medical diagnostic data, collectively referred to herein as clinical data, which includes diagnostic data and/or patient history data.
- clinical data which includes diagnostic data and/or patient history data.
- the user interface produces, for each patient, an EPR segment 2 containing the diagnostic and/or patient history data.
- the EPR segments 1 and the EPR segments 2 are electronically transmitted to a database in a central server, wherein they are stored.
- the central server also includes a unit for evaluation and testing of the information in the database, according to algorithms for performing statistical analysis.
- the central server is connected to a user interface, at which expert rules, such as for a measurement protocol for a selected pathology, are displayed as a result of the evaluation and testing conducted in the central server.
- the user interface also makes available information regarding biochip test sensitivity and specificity, and if necessary, documentation for approval of the measurement protocol.
- the expert rule can be modified.
- Figure 2 shows an example of an information exchanges for ex- plaining the manner by which such biosensor arrays and EPRs are used in the inventive network and procedure, assume that a diagnostic test for a certain disease, such as cervical cancer, using five different biomolecular markers, is approved and is regularly practiced in the daily routine in a physician's office to diagnose women with the suspicion of developing this type of cancer, or a screening tool for women who may be at risk from a certain age to develop cervical cancer. A 'cervical cancer biochip" is then available for conducting all of the diagnostic tests which are a part of the approved routine for the five markers.
- a diagnostic test for a certain disease such as cervical cancer
- five different biomolecular markers is approved and is regularly practiced in the daily routine in a physician's office to diagnose women with the suspicion of developing this type of cancer, or a screening tool for women who may be at risk from a certain age to develop cervical cancer.
- a 'cervical cancer biochip is then available for conducting all of the diagnostic tests which are a part of
- a disposable biochip with an appropriate sample from the patient is obtained, and the disposable chip with the patient sample is inserted into a suitable point of care test device, such as at the physician's office (step 1 in Figure 2) .
- the diagnostic test is conducted, possibly with the point of care test device requesting measurement protocols for conducting the tests via a communication link with a remote server (step 2 in Figure 2) . If such a request is made, the remote server, from a data bank of measurement protocols, selects the ap- intestinalte measurement protocol and transmits it back via the data link to the point of care test device (step 3 in Figure 2) .
- the protocol can be stored in the device itself, in which case there is no need to estab- lish communication at the time of the test with the remote server.
- a ⁇ protocol not only specifies a pro- cedure, but also the markers which are to be considered in the procedure.
- the results of the diagnostic test conducted using the " cer- vical cancer biochip" are entered into and stored in the EPR of the patient, which is accessible at the point of care site via a data entry station. Since no medical diagnostic test can be unequivocally stated to have a 100% accuracy, there will always be the possibility of a false positive result or a false negative result. In false positive cases, the patient (as a result of the false positive diagnosis) will be referred to a clinic for further evaluation, such as for conducting a biopsy. The biopsy analysis will show that there is, in fact, no cancer present, and this will also be indi- cated in the patient's EPR.
- testing can be undertaken using stored ( ⁇ old") data from EPRs, or EPRs which are continuously updated, and increasing in number, can be used.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002565137A JP2004527825A (en) | 2001-02-15 | 2002-02-14 | Network for evaluating data obtained from biochip measurement devices |
EP02740081A EP1370695A2 (en) | 2001-02-15 | 2002-02-14 | Network for evaluating data obtained in a biochip measurement device |
CA002438343A CA2438343A1 (en) | 2001-02-15 | 2002-02-14 | Network for evaluating data obtained in a biochip measurement device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/784,720 | 2001-02-15 | ||
US09/784,720 US7315784B2 (en) | 2001-02-15 | 2001-02-15 | Network for evaluating data obtained in a biochip measurement device |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002064826A2 true WO2002064826A2 (en) | 2002-08-22 |
WO2002064826A3 WO2002064826A3 (en) | 2003-10-09 |
Family
ID=25133324
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2002/001565 WO2002064826A2 (en) | 2001-02-15 | 2002-02-14 | Network for evaluating data obtained in a biochip measurement device |
Country Status (5)
Country | Link |
---|---|
US (1) | US7315784B2 (en) |
EP (1) | EP1370695A2 (en) |
JP (1) | JP2004527825A (en) |
CA (1) | CA2438343A1 (en) |
WO (1) | WO2002064826A2 (en) |
Cited By (12)
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WO2007113468A1 (en) * | 2006-03-30 | 2007-10-11 | Randox Laboratories Limited | Method and apparatus for monitoring the properties of a biological or chemical sample |
US7516351B2 (en) | 2003-09-17 | 2009-04-07 | Hitachi, Ltd. | Distributed testing apparatus and host testing apparatus |
US10533994B2 (en) | 2006-03-24 | 2020-01-14 | Theranos Ip Company, Llc | Systems and methods of sample processing and fluid control in a fluidic system |
US10557786B2 (en) | 2011-01-21 | 2020-02-11 | Theranos Ip Company, Llc | Systems and methods for sample use maximization |
US10634667B2 (en) | 2007-10-02 | 2020-04-28 | Theranos Ip Company, Llc | Modular point-of-care devices, systems, and uses thereof |
US10761030B2 (en) | 2005-05-09 | 2020-09-01 | Labrador Diagnostics Llc | System and methods for analyte detection |
US11139084B2 (en) | 2009-10-19 | 2021-10-05 | Labrador Diagnostics Llc | Integrated health data capture and analysis system |
US11162947B2 (en) | 2006-05-10 | 2021-11-02 | Labrador Diagnostics Llc | Real-time detection of influenza virus |
US11215610B2 (en) | 2006-10-13 | 2022-01-04 | Labrador Diagnostics Llc | Reducing optical interference in a fluidic device |
US11287421B2 (en) | 2006-03-24 | 2022-03-29 | Labrador Diagnostics Llc | Systems and methods of sample processing and fluid control in a fluidic system |
US11754554B2 (en) | 2007-08-06 | 2023-09-12 | Labrador Diagnostics Llc | Systems and methods of fluidic sample processing |
US11802882B2 (en) | 2006-11-14 | 2023-10-31 | Labrador Diagnostics Llc | Methods for the detection of analytes in small-volume blood samples |
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US20030097222A1 (en) * | 2000-01-25 | 2003-05-22 | Craford David M. | Method, system, and computer software for providing a genomic web portal |
US20020183936A1 (en) * | 2001-01-24 | 2002-12-05 | Affymetrix, Inc. | Method, system, and computer software for providing a genomic web portal |
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US20140025809A1 (en) * | 2012-07-19 | 2014-01-23 | Cepheid | Remote monitoring of medical devices |
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- 2002-02-14 WO PCT/EP2002/001565 patent/WO2002064826A2/en not_active Application Discontinuation
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- 2002-02-14 JP JP2002565137A patent/JP2004527825A/en active Pending
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US10533994B2 (en) | 2006-03-24 | 2020-01-14 | Theranos Ip Company, Llc | Systems and methods of sample processing and fluid control in a fluidic system |
US11287421B2 (en) | 2006-03-24 | 2022-03-29 | Labrador Diagnostics Llc | Systems and methods of sample processing and fluid control in a fluidic system |
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WO2007113468A1 (en) * | 2006-03-30 | 2007-10-11 | Randox Laboratories Limited | Method and apparatus for monitoring the properties of a biological or chemical sample |
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Also Published As
Publication number | Publication date |
---|---|
US7315784B2 (en) | 2008-01-01 |
WO2002064826A3 (en) | 2003-10-09 |
US20020120183A1 (en) | 2002-08-29 |
JP2004527825A (en) | 2004-09-09 |
EP1370695A2 (en) | 2003-12-17 |
CA2438343A1 (en) | 2002-08-22 |
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