Devices and methods for nucleic acid extraction
Inventors
Swenson, David D. • Loney, Gregory C. • REVILLA, Valeria • LAM, Adrienne C. • Huang, Helen • Kelly, Colin • Briones, Victor • Ciopyk, Brian • Andreyev, Boris • De La Zerda, Adam • Moravick, Keith • Ching, Jesus • Albrecht, Jennifer • CENA, Ryan • BIBA, Edward • Hong, Jonathan
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Assignees
Member
Visby MedicalVisby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Visby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Publication Number
US-11193119-B2
Publication Date
2021-12-07
Expiration Date
Abstract
Disclosed herein are methods and devices for preparing a sample of nucleic acid molecules from a biological sample. The methods and devices may perform similarly to or better than standard sample preparation methods. The nucleic acid molecules prepared using the methods and devices provided herein may be utilized for downstream applications, including polymerase chain reaction (PCR).
Core Innovation
The invention relates to devices and methods for rapid nucleic-acid extraction from a biological sample in a molecular diagnostic test device. The method conveys a biological sample into a sample input module and actuates the device to convey the biological sample to a lysing module that includes a heater. The lysing module defines a first reaction volume and a second reaction volume, and an input solution containing the biological sample and a lysis buffer is maintained within the first reaction volume to lyse at least a portion of the biological sample for extracting a plurality of nucleic acid molecules.
A heater is activated to heat a portion of the lysing module to produce an inactivation temperature zone within the second reaction volume. A flow of the input solution is produced within the second reaction volume such that a volume of the input solution is heated within the inactivation temperature zone to inactivate an enzyme within the input solution. The device architecture is described as point-of-care, handheld, single-use, and includes sample input, wash, elution, and lysing/inactivation modules integrated within the molecular diagnostic test device.
The described system further includes downstream amplification and detection modules for molecular diagnostic testing, including PCR/amplification and a detection module. The content also describes physical features for fluid handling and temperature control during lysing/inactivation, including an inactivation temperature zone created using a heater and a flow path/channel, and vent and check-valve elements for regulating fluid flow. Optional fluid sensing/probes for detecting liquid presence are described as part of the lysing module operation.
Claims Coverage
The partial content includes one independent claim. The independent claim covers a nucleic-acid extraction method in a molecular diagnostic test device using defined first and second reaction volumes for lysis and enzyme inactivation, respectively, by heater-driven creation of an inactivation temperature zone and flowing the input solution through that zone.
Heater-driven inactivation temperature zone using first and second reaction volumes
A method in a molecular diagnostic test device conveying a biological sample to a lysing module that defines a first reaction volume and a second reaction volume, maintaining an input solution and lysis buffer in the first reaction volume to lyse and extract nucleic acid molecules, and actuating a heater to produce an inactivation temperature zone within the second reaction volume and flowing the input solution so a volume heated within the inactivation temperature zone inactivates an enzyme.
Across the provided partial claim set, the core inventive coverage centers on lysing in a first reaction volume while creating and using a heater-produced inactivation temperature zone in a second reaction volume via flow, in order to inactivate an enzyme during nucleic-acid extraction in a molecular diagnostic test device.
Stated Advantages
Rapid nucleic-acid extraction from biological samples in a point-of-care, handheld, single-use device architecture.
Produces PCR-compatible nucleic-acid quality suitable for downstream amplification and detection, including real-time PCR.
Demonstrates tolerance to PCR inhibition conditions using buffer/inhibition testing with spiked samples.
Documented Applications
Real-time PCR and PCR performed on multiple clinical samples, including clinical samples containing N. gonorrhoeae and C. trachomatis.
Molecular diagnostic testing using the described nucleic-acid extraction followed by amplification (PCR/qPCR) and detection.
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