Devices and methods for antibiotic susceptibility testing
Inventors
Ciopyk, Brian • Dentinger, Paul • ABRAHAM, Teresa • MA, Brandon • KAJOUKE, Kamal • HUNT, Mackenzie • PHUNG, Austin • Guegler, Karl • Swenson, David • Postlethwaite, Anna H.
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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-11952636-B2
Publication Date
2024-04-09
Expiration Date
Abstract
The disclosure relates generally to molecular diagnostic devices configured to amplifying a single nucleotide polymorphism (SNP) locus and discriminate between two or more allelic variants of the SNP, indicating presence or absence of a target allele. In some embodiments, the molecular diagnostic devices are capable of detecting, at point-of-care, SNPs associated with resistance or susceptibility to antibiotic treatment of organism infections. In other aspects, the disclosure provides methods of treatment for disease or disorders (e.g. organism infections) where treatment is guided by presence or absence of an allele at a SNP locus as determined by such molecular diagnostic devices.
Core Innovation
The invention is a molecular diagnostic device for point-of-care disposable molecular diagnostic testing that detects a target organism and differentiates alleles at a single nucleotide polymorphism (SNP) locus associated with resistance and susceptibility to a treatment. The device includes a sample preparation module configured to mix a primer set with a biological sample suspected of comprising a polynucleotide from the target organism, an amplification module that produces a first amplicon comprising a first genetic locus and a second amplicon comprising a second genetic locus, and a detection module with a reagent module.
A detection module includes a first probe, a second probe, and a third probe. The first probe binds to the first genetic locus to indicate presence of the target organism, while the second probe binds to the second genetic locus when it comprises a first target allele associated with resistance and the third probe binds when it comprises a second target allele associated with susceptibility. The second probe melting temperature is different from the third probe melting temperature, and the device generates first, second, and third signals indicating organism presence, resistance-associated allele presence, and susceptibility-associated allele presence.
The disclosed detection strategy includes a flow member defining a detection channel and first, second, and third detection surfaces having probes adhered thereto. The probe set comprises non-polymorphic and polymorphic locus probes matched to resistance-associated and susceptibility-associated alleles, and the approach is described as enabling allele-specific hybridization without melting curve analysis. Results are read via separate detection surfaces and may be read visually via color products or digitally using light sources and photodetectors.
Claims Coverage
The partial content includes three independent claims. Across these independent claims, the coverage centers on a molecular diagnostic device, a detection module with three probe-bound detection surfaces in a flow channel, and a probe set for detecting target organism presence and resistance versus susceptibility alleles, with three inventive features in total.
Three-probe SNP allele discrimination with melting temperature separation
A molecular diagnostic device that prepares an input solution by mixing a primer set with a biological sample suspected of comprising a polynucleotide from a target organism; amplifies first and second genetic loci to produce first and second amplicons; uses a detection module with a first probe for the first genetic locus and a second probe and third probe for the second genetic locus to bind resistance-associated and susceptibility-associated alleles; and generates first, second, and third signals corresponding to organism presence, resistance-associated allele presence, and susceptibility-associated allele presence, wherein the second probe and third probe have different probe melting temperatures for hybridization.
Flow-channel detection module with separate probe-bound detection surfaces
A detection module of a molecular diagnostic device with a flow member defining a detection channel to receive an output solution containing first and second amplicons; having a first detection surface with a first probe to produce a first signal indicating presence of the target organism; a second detection surface with a second probe to produce a second signal indicating presence of a resistance-associated first target allele; and a third detection surface with a third probe to produce a third signal indicating presence of a susceptibility-associated second target allele within the target organism associated with susceptibility to the treatment.
Probe set for detecting organism presence and resistance versus susceptibility at a polymorphic locus
A probe set comprising a first oligonucleotide probe complementary to a non-polymorphic locus, a second oligonucleotide probe complementary to a polymorphic locus and matched to an allele associated with resistance to a drug, and a third oligonucleotide probe complementary to the polymorphic locus and matched to an allele associated with susceptibility to the drug, wherein the second and third probes have different melting temperatures for hybridization to the respective resistance and susceptibility alleles.
Overall, the claims coverage centers on a three-probe architecture that outputs distinct signals for target organism presence and SNP-associated resistance versus susceptibility alleles, with allele-specific discrimination driven by a difference in probe melting temperatures. A separate independent detection-module claim further emphasizes probe immobilization on distinct detection surfaces within a flow channel.
Stated Advantages
Facilitates production of signals indicating presence of the bound first genetic locus, presence of resistance-associated allele, and presence of susceptibility-associated allele.
Distinguishes target organism presence from resistance versus susceptibility associated alleles using separate signals based on probe binding to different SNP alleles.
Differentiates resistance-associated versus susceptibility-associated allele hybridization using different probe melting temperatures.
Enables allele-specific hybridization by using different probe melting temperatures for the resistance-associated allele and the susceptibility-associated allele.
Enables detection of the target organism and detection of at least one resistance-associated allele or susceptibility-associated allele via probe-bound detection surfaces.
Enables allele-specific hybridization without melting curve analysis.
Documented Applications
Drug susceptibility/resistance molecular diagnosis of infections associated with a target organism, including resistance versus susceptibility to a treatment.
Detection of a target organism and detection of a first target allele associated with resistance or a second target allele associated with susceptibility to the treatment.
Probe set use for detecting presence of a target organism and susceptibility to a drug by contacting the probe set with amplicons produced by amplifying loci in the target organism.
Antibiotic susceptibility testing at a point-of-care using a disposable portable single-use molecular diagnostic device.
Detection and differentiation for Neisseria gonorrhoeae and antibiotic treatment, including ciprofloxacin (CIP) using a gyrA Ser-91 (ciprofloxacin-susceptible) and gyrA codon variants associated with resistance-associated alleles.
Rationale for avoiding microarrays/SNP arrays at point-of-care by using a probe-based detection approach with separate detection surfaces and melting-temperature differences rather than melting curve analysis.
Interested in licensing this patent?