Patent Issued for Systems and methods for multi-analysis (USPTO 11162936): Labrador Diagnostics LLC

2021 NOV 18 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Holmes, Elizabeth A. (Palo Alto, CA, US), Loo, Alexander (Redwood City, CA, US), Roy, Joy (San Jose, CA, US), Smith, Timothy (San Ramon, CA, US), Young, Daniel (San Francisco, CA, US), filed on May 15, 2017, was published online on November 2, 2021.

The patent’s assignee for patent number 11162936 is Labrador Diagnostics LLC (Wilmington, Delaware, United States).

News editors obtained the following quote from the background information supplied by the inventors: “The majority of clinical decisions are based on laboratory and health test data, yet the methods and infrastructure for collecting such data severely limit the quality and utility of the data itself. Almost all errors in laboratory testing are associated with human or pre-analytic processing errors, and the testing process can take days to weeks to complete. Often times by the time a practicing physician gets the data to effectively treat a patient or determine the most appropriate intervention, he or she has generally already been forced to treat a patient empirically or prophylactically as the data was not available at the time of the visit or patient triage. Earlier access to higher quality testing information at the time of patient triage enables earlier interventions and better management of disease progression to improve outcomes and lower the cost of care.

“Existing systems and methods for clinical testing suffer major drawbacks from the perspectives of patients, medical care professionals, taxpayers, and insurance companies. Today, consumers can undergo certain specialized tests at clinics or other specialized locations. If a test is to be conducted and the result of which is to be eventually relied on by a doctor, physical samples are transported to a location which performs the test on the samples. For example, these samples may comprise blood from a venous draw and are typically collected from a subject at the specialized locations. Accessibility of these locations and the venipuncture process in and of itself is a major barrier in compliance and frequency of testing. Availability for visiting a blood collection site, the fear of needles-especially in children and elderly persons who, for example, often have rolling veins, and the difficulty associated with drawing large amounts of blood drives people away from getting tested even when it is needed. Thus, the conventional sampling and testing approach is cumbersome and requires a significant amount of time to provide test results. Such methods are not only hampered by scheduling difficulties and/or limited accessibility to collection sites for subjects to provide physical samples but also by the batch processing of samples in centralized laboratories and the associated turn around time in running laboratory tests. As a result, the overall turn around time involved in getting to the collection site, acquiring the sample, transporting the sample, testing the sample and reporting and delivering results becomes prohibitive and severely limits the timely provision of the most informed care from a medical professional. This often results in treatment of symptoms as opposed to underlying disease conditions or mechanisms of disease progression.

“In addition, traditional techniques are problematic for certain diagnoses. Some tests may be critically time sensitive, but take days or weeks to complete. Over such a time, a disease can progress past the point of treatment. In some instances, follow-up tests are required after initial results, which take additional time as the patient has to return to the specialized locations. This impairs a medical professional’s ability to provide effective care. Furthermore, conducting tests at only limited locations and/or infrequently reduces the likelihood that a patient’s status can be regularly monitored or that the patient will be able to provide the samples quickly or as frequently as needed. For certain diagnoses or conditions, these deficiencies inevitably cause inadequate medical responses to changing and deteriorating physiological conditions. Traditional systems and methods also affect the integrity and quality of a clinical test due to degradation of a sample that often occurs while transporting such sample from the site of collection to the place where analysis of the sample is performed. For example, analytes decay at a certain rate, and the time delay for analysis can result in loss of sample integrity. Different laboratories also work with different quality standards which can result in varying degrees of error. Additionally, preparation and analysis of samples by hand permits upfront human error to occur at various sample collection sites and laboratories. These and other drawbacks inherent in the conventional setup make it difficult to perform longitudinal analyses, especially for chronic disease management, with high quality and reliability

“Furthermore, such conventional analytical techniques are often not cost effective. Excessive time lags in obtaining test results lead to delays in diagnoses and treatments that can have a deleterious effect on a patient’s health; as a disease progresses further, the patient then needs additional treatment and too often ends up unexpectedly seeing some form of hospitalization. Payers, such as health insurance companies and taxpayers contributing to governmental health programs, end up paying more to treat problems that could have been averted with more accessible and faster clinical test results.”

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors’ summary information for this patent: “Being able to detect a disease or the onset of a disease in time to manage and treat it is a capability deeply sought after by patients and providers alike but one that has yet to be realized in the current healthcare system where detection too often coincides with fatal prognoses.

“A need exists for improved systems and methods for sample collection, sample preparation, assay, and/or detection. A further need exists for systems and devices that perform one or more of the sample collection, preparation, assay, or detection steps. Systems and methods are needed at the time and place in which care is provided for rapid, frequent and/or more accurate diagnoses, ongoing monitoring, and facilitation and guidance of treatment. Systems and methods disclosed herein meet this and related needs.

“In accordance with an aspect of the invention, a system may comprise: a plurality of modules mounted on a support structure, wherein an individual module of said plurality of modules comprises a sample preparation station, assay station, and/or detection station, wherein the system is configured to perform (a) at least one sample preparation procedure selected from the group consisting of sample processing, centrifugation, separation, and chemical processing, and (b) multiple types of assays selected from the group consisting of immunoassay, nucleic acid assay, receptor-based assay, cytometric assay, colorimetric assay, enzymatic assay, electrophoretic assay, electrochemical assay, spectroscopic assay, chromatographic assay, microscopic assay, topographic assay, calorimetric assay, turbidimetric assay, agglutination assay, radioisotope assay, viscometric assay, coagulation assay, clotting time assay, protein synthesis assay, histological assay, culture assay, osmolarity assay, and combinations thereof; and wherein the multiple types of assays are performed with the aid of isolated (including but not limited to fluidically) assay units contained within the system. In some embodiments, separation includes magnetic separation.

“Additional aspects of the invention may be directed to a system, comprising: a plurality of modules mounted on a support structure, wherein an individual module of said plurality of modules comprises a sample preparation station, assay station, and/or detection station, wherein the system is configured to perform (a) at least one sample preparation procedure selected from the group consisting of sample processing, centrifugation, separation, and chemical processing, and (b) one or more types of assays selected from the group consisting of immunoassay, nucleic acid assay, receptor-based assay, cytometric assay, colorimetric assay, enzymatic assay, electrophoretic assay, electrochemical assay, spectroscopic assay, chromatographic assay, microscopic assay, topographic assay, calorimetric assay, turbidimetric assay, agglutination assay, radioisotope assay, viscometric assay, coagulation assay, clotting time assay, protein synthesis assay, histological assay, culture assay, osmolarity assay, and combinations thereof; and wherein the system is configured to process or assay a sample having a volume less than or equal to 250 and the system has a coefficient of variation less than or equal to 15%. In some embodiments, separation includes magnetic separation.

“A system may be provided in accordance with another aspect of the invention, said system comprising: a preparation station configured to perform sample preparation; and an assay station configured to perform multiple types of assays selected from the group consisting of immunoassay, nucleic acid assay, receptor-based assay, cytometric assay, colorimetric assay, enzymatic assay, electrophoretic assay, electrochemical assay, spectroscopic assay, chromatographic assay, microscopic assay, topographic assay, calorimetric assay, turbidimetric assay, agglutination assay, radioisotope assay, viscometric assay, coagulation assay, clotting time assay, protein synthesis assay, histological assay, culture assay, osmolarity assay, and combinations thereof; and wherein the system is configured to perform said sample preparation and said multiple types of assays within 4 hours or less.”

The claims supplied by the inventors are:

“1. A method for performing multiple assays with a biological sample, the method comprising: providing a point-of-service, benchtop biological sample processing device comprising a housing containing therein: an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle; a cartridge comprising a microscopy cuvette, a pipette tip, a reagent, a diluent, a vessel, and a microfluidic cartridge, said microfluidic cartridge having a planar configuration and is removable from the cartridge by the fluid handling apparatus so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use, wherein said nozzle of the fluid handling apparatus configured to: a) engage and hold a pipette tip and b) to engage and hold a microscopy cuvette, wherein said microscopy cuvette is configured to engage said pipette nozzle; a first detection station comprising an electronic optical sensor; a second detection station comprising a light source and an electronic optical sensor; and a nucleic acid assay station, transferring, by the fluid handling apparatus of the automated sample handling system, the microfluidic cartridge from the cartridge, so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use; transferring by the automated sample handling system at least a portion of the biological sample to each of a first unit, second assay unit, and third assay unit of the cartridge; transferring by the automated sample handling system the first assay unit containing biological sample to the first detection station; transferring by the automated sample handling system the second assay unit containing biological sample to the second detection station; transferring by the automated sample handling system the third assay unit containing biological sample to the nucleic acid assay station; and transferring from the cartridge to the first assay unit, second assay unit, and third assay unit, respectively, all reagents required for the performance of first, second, and third assays to the respective assay units.

“2. The method of claim 1, wherein the biological sample has a volume of no greater than 500 microliters.

“3. The method of claim 1, wherein a turbidimetric assay is performed in the second assay unit, and wherein the turbidity of the turbidimetric assay is measured over a period of time.

“4. The method of claim 1, wherein the electronic optical sensor is selected from the group of electronic optical sensors consisting of photodiodes, photomultiplier tubes (PMTs), Charge-Coupled Devices (CCDs), super-cooled CCD arrays, CMOS sensors, photodetectors, photon counting detectors, avalanche photodiodes, avalanche photodiode arrays, pin diodes, spectrophotometers, and electronic cameras.

“5. The method of claim 1, wherein the biological sample is from a subject, and wherein prior to insertion of the cartridge into the biological sample processing device, the subject’s insurance coverage is checked.

“6. The method of claim 1, wherein the biological sample processing device further comprises a third detection station, wherein the cartridge further contains a fourth assay unit, wherein the fourth assay unit comprises gear teeth, and wherein the method further comprises transporting the fourth assay unit to the third detection station by rotation of a gear mechanism, wherein rotation of the gear mechanism engages the gear teeth in the fourth assay unit and moves the fourth assay unit into the third detection station.

“7. The method of claim 1, wherein the cartridge comprises a lid and a locking feature, wherein the lid comprises an engagement feature which is configured to optionally engage the locking feature in the cartridge, and wherein the engagement feature does not engage the locking feature in the cartridge upon insertion of the cartridge into the sample processing device.

“8. The method of claim 1, wherein the second detection station comprises a cytometry station, wherein the light source and electronic optical sensor or sensing device of the second detection station are contained within the cytometry station.

“9. The method of claim 1 wherein the nucleic acid assay station comprises a heater.

“10. A method for performing multiple assays with a biological sample, the method comprising: providing a point-of-service, benchtop biological sample processing device comprising a housing containing therein: an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle; a cartridge comprising a microscopy cuvette, a pipette tip, a reagent, a diluent, a vessel, and a microfluidic cartridge; a first detection station comprising an electronic optical sensor; a second detection station comprising a light source and an electronic optical sensor; and a nucleic acid assay station, transferring, by the fluid handling apparatus of the automated sample handling system, the microfluidic cartridge from the cartridge, so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use; transferring by the automated sample handling system at least a portion of the biological sample to the vessel; transferring by the automated sample handling system the vessel containing biological sample to the first detection station.

“11. The method of claim 10, wherein the biological sample has a volume of no greater than 500 microliters.

“12. The method of claim 10, wherein the electronic optical sensor is selected from the group of electronic optical sensors consisting of photodiodes, photomultiplier tubes (PMTs), Charge-Coupled Devices (CCDs), super-cooled CCD arrays, CMOS sensors, photodetectors, photon counting detectors, avalanche photodiodes, avalanche photodiode arrays, pin diodes, spectrophotometers, and electronic cameras.

“13. The method of claim 10, wherein the biological sample is from a subject, and wherein prior to insertion of the cartridge into the biological sample processing device, the subject’s insurance coverage is checked.

“14. The method of claim 10, wherein the biological sample processing device further comprises a third detection station.

“15. The method of claim 10, wherein the cartridge comprises a lid and a locking feature, wherein the lid comprises an engagement feature which is configured to optionally engage the locking feature in the cartridge, and wherein the engagement feature does not engage the locking feature in the cartridge upon insertion of the cartridge into the sample processing device.

“16. The method of claim 10, wherein the second detection station comprises a cytometry station, wherein the light source and electronic optical sensor or sensing device of the second detection station are contained within the cytometry station.

“17. The method of claim 10 wherein the nucleic acid assay station comprises a heater.

“18. A method for performing multiple assays with a biological sample, the method comprising: providing a point-of-service, benchtop biological sample processing device comprising a housing containing therein: an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle; a cartridge comprising a microscopy cuvette, a pipette tip, a reagent, a diluent, a vessel, and a microfluidic cartridge; a first detection station comprising an electronic optical sensor; a second detection station comprising a light source and an electronic optical sensor; and a nucleic acid assay station, transferring, by the fluid handling apparatus of the automated sample handling system, the microfluidic cartridge from the cartridge, so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use; transferring, by the automated sample handling system, at least a portion of the biological sample to the vessel; transferring, by the automated sample handling system, the vessel containing biological sample to the nucleic acid assay station; and performing nucleic acid amplification using said nucleic acid assay station.

“19. The method of claim 18, wherein said nucleic acid amplification uses isothermal heating.

“20. The method of claim 18, wherein said nucleic acid amplification uses thermocycling.”

For additional information on this patent, see: Holmes, Elizabeth A. Systems and methods for multi-analysis. U.S. Patent Number 11162936, filed May 15, 2017, and published online on November 2, 2021. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=11162936.PN.&OS=PN/11162936RS=PN/11162936

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