IP Library › Granted Patent US 12,428,674
Granted Patent B2
US 12,428,674 · App. 18/437,399 · Granted Sep 30, 2025

System and self-metering cartridges for point of care bioassays

Inventors: Arturo M. Escajeda (Oakland, CA); Huyen Tran (San Jose, CA); Ming X. Tan (San Ramon, CA)
Assignee: Wainamics, Inc.
C12Q1/6844B01L3/502715B01L7/52B01L2200/04B01L2200/16B01L2300/0654B01L2300/087B01L2300/0883B01L2300/1805B01L2400/0481B01L2400/049B01L2400/0677
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,428,674
App. No.
18/437,399
Granted
Sep 30, 2025
Kind
B2
Abstract

The invention is directed to devices and methods for performing rapid low-cost bioassays in self-contained disposable cartridges that provide efficient mixing of sample and reactants under a layer of liquid wax. Some embodiments additionally use gravity assisted distribution of sample and assay reagents in conjunction with an appliance containing all necessary valves, pneumatic sources, heat sources and detection stations.

Claims (10)

1. A device for performing a bioassay for one or more target polynucleotides comprising:

a sample chamber comprising a first inlet for accepting a biological sample, a vent port allowing the passage of air but not liquid, and an outlet connected to a first conduit;

a metering chamber comprising a metering vent port and connected to and in fluid communication with the outlet of the sample chamber through the first conduit;

a reagent chamber capable of containing assay reagents, the reagent chamber being connected to the metering chamber by a passage and connected to a reagent vent port allowing the passage of air but not liquid;

a mixing chamber for mixing the biological sample with one or more assay reagents to form a reaction mixture, the mixing chamber having a top and a bottom and being in fluid communication with the metering chamber by a passage connecting the bottom of the mixing chamber to the metering chamber, the mixing chamber being connected at its top to a vent port that allows the passage of air but not liquid, wherein the reaction mixture is mixed by forcing air from a vent port of the metering chamber or the reaction chamber into the the bottom of the mixing chamber; and

a detection chamber in fluid communication with the mixing chamber by a passage connected to the bottom of the mixing chamber.

2. The device of claim 1 wherein said mixing chamber or said reagent chamber or both said chambers contain a predetermined quantity of wax having a melting temperature such that the wax forms a bubble-preventing layer on said reaction mixture whenever said mixing chamber is above the melting temperature.

3. The device of claim 2 wherein said passage connecting said detection chamber to said bottom of said mixing chamber comprises an amplification chamber.

4. The device of claim 3 wherein said amplification chamber is configured to produce a predetermined temperature in the range of from 55° C. to 70° C.

5. The device of claim 3 wherein said amplification chamber is configured to produce a predetermined temperature in the range of from 30° C. to 60° C.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2025
From: ESCAJEDA, ARTURO; TRAN, HUYEN; TAN, MING X.
To: WAINAMICS, INC.
Reel/Frame 072410/0234 →
Continuity (5)
Continuation 18016630
Continuation In Part 17158130 · Jan 26, 2021
Continuation In Part 17129783 · Dec 21, 2020
Provisional Application 63058535 · Jul 30, 2020
Related Publication 20240360497A1 · Oct 31, 2024
References Cited (51)
US 5096669A · Lauks · 1992 [cited by applicant]
US 6379929B1 · Burns · 2002 [cited by applicant]
US 6410278B1 · Notomi · 2002 [cited by applicant]
US 7264932B2 · Latham · 2007 [cited by applicant]
US 8673567B2 · Wang · 2014 [cited by applicant]
US 9133024B2 · Phan · 2015 [cited by applicant]
US 9731297B2 · Glezer · 2017 [cited by applicant]
US 9797006B2 · Niemz · 2017 [cited by applicant]
US 9797899B2 · Bornheimer · 2017 [cited by applicant]
US 9962698B2 · Ingber · 2018 [cited by applicant]
US 10073093B2 · Bornheimer · 2018 [cited by applicant]
US 10107797B2 · Battrell · 2018 [cited by applicant]
US 10807093B2 · Belotserkovsky · 2020 [cited by applicant]
US 11898197B2 · Escajeda · 2024 [cited by examiner]
US 11904315B2 · Escajeda · 2024 [cited by examiner]
US 20020168671A1 · Burns · 2002 [cited by applicant]
US 20080026451A1 · Braman · 2008 [cited by applicant]
US 20080182312A1 · Pack · 2008 [cited by applicant]
US 20100035349A1 · Bau · 2010 [cited by examiner]
US 20130344563A1 · Raines · 2013 [cited by applicant]
US 20150125882A1 · Bornheimer · 2015 [cited by applicant]
US 20160175840A1 · Ingber · 2016 [cited by applicant]
US 20180016537A1 · Levner · 2018 [cited by applicant]
US 20180236446A1 · Malkin et al. · 2018 [cited by applicant]
US 20190232284A1 · Travi · 2019 [cited by applicant]
WO WO2016073415 · 2016 [cited by applicant]
WO WO2018175169 · 2018 [cited by applicant]
WO WO2022026670 · 2022 [cited by applicant]
Chen et al, “An integrated, self-contained microfluidic cassette for isolation, amplification, and detection of nucleic acids,” Biomed. Microdevices, 12(4): 705-719 (2010). [cited by applicant]
Chin et al, “Commercialization of microfluidic point-of-care diagnostic devices,” LabChip, 12: 2118-2134 (2012). [cited by applicant]
Findlay et al, “Automated closed-vessel system for in vitro diagnostics based on polymerase chain reaction,” Clin. Chem., 39(9): 1927-1933 (1993). [cited by applicant]
Gadkar et al, “Real-time detection and monitoring of loop mediated amplification (LAMP) reaction using self-quenching and de-quenching fluorogenic probes,” Scientific Reports, 8:5548 (2018). [cited by applicant]
Gill et al, “Nucleic acid isothermal amplification technologies,” Nucleosides, Nucleotides, and Nucleic Acids, 27: 224-243 (2008). [cited by applicant]
Goto et al, “Colorimetric detection of loop-mediated isothermal amplification reaction by using hydroxyl naphthol blue,” BioTechniques, 46: 167-172 (2009). [cited by applicant]
Haeberle et al, “Microfluidic platforms for lab-on-a-chip applications,” LabChip, 7: 1094-1110 (2007). [cited by applicant]
Hardinge et al, “Reduced false positives and improved reporting of loop-mediated isothermal amplification using quenched fluorescent primers,” Scientific Reports, 9:7400 (2019). [cited by applicant]
Hitzbleck et al, “Reagents in microfluidics: an ‘in’ and ‘out’ challenge,” Chem. Soc. Rev., 42: 8494 (2013). [cited by applicant]
Karami et al, “A review of the current isothermal amplification techniques: applications, advantages and disadvantages,” J. Global Infectious Diseases, 3(3): 293-302 (2011). [cited by applicant]
Kim et al, “Microfluidic sample preparation: cell lysis and nucleic acid purification,” Integrative Biology, 1: 574-586 (2009). [cited by applicant]
Lee et al, “Bubble-free rapid microfluidic PCR,” Biosensors and Bioelectronics, 126: 725-733 (2019). [cited by applicant]
Lochovsky, “Trapping and removal of bubbles in a microfluidic format,” Thesis, Institute of Biomaterials and Biomedical Engineering, University of Toronto (2012). [cited by applicant]
Nge et al, “Advances in microfluidic materials, functions, integration and applications,” Chem. Rev., 113(4): 2550-2583 (2013). [cited by applicant]
Nie et al, “Evaluation of Alere i influenza A&B for rapid detection of influenza viruses A and B,” J. Clinical Microbiology, 52(9): 3339-3344 (2014). [cited by applicant]
Oscorbin et al, “Comparison of fluorescent intercalating dyes for quantitative loop-mediated isothermal amplification (LAMP)” BioTechniques, 61(1): 20-25 (2016). [cited by applicant]
Periero et al, “Nip the bubble in the bud: a guide to avoid gas nucleation in microfluidics,” LabChip, 19: 2296-2314 (2019). [cited by applicant]
Quyen et al, “Classification of multiple DNA dyes based on inhibition effects on real-time loop-mediated isothermal amplification (LAMP): Prospect for point of care setting,” Frontiers in Microbiology, 10:2234, doi: 10.… [cited by applicant]
Ren et al, “Materials for microfluidic chip fabrication,” Accounts of Chemical Research, 46(11): 2396-2406 (2013). [cited by applicant]
Smith et al, “Blister pouches for effective reagent storage on microfluidics chips for blood cell counting,” Microfluid Nanofluid, 20: 163 (2016). [cited by applicant]
Svec et al, “Direct cell lysis for single-cell gene expression profiling,” Frontiers in Oncology, 3: article 274 (2013). [cited by applicant]
Zhang et al, “Rapid molecular detection of SARS-CoV-2 (COVID-2) virus RNA using colorimetric LAMP,” medRxiv, doi.org/10.1101/2020.02.26.20028373 (Feb. 29, 2020). [cited by applicant]
Zhu et al, “Development of a new method for turbidity measurement using two NIR digital cameras,” ACS Omega, 5: 5421-5428 (2020). [cited by applicant]