Devices and methods for antibiotic susceptability testing
Inventors
Ciopyk, Brian • Dentinger, Paul • ABRAHAM, Teresa • MA, Brandon • KAJOUKE, Kamal • HUNT, Mackenzie • PHUNG, Austin
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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-11352675-B2
Publication Date
2022-06-07
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
A molecular diagnostic test device detects the presence of a target organism and determines the presence of at least one first target allele associated with resistance to a treatment or a second target allele associated with susceptibility to the treatment. A biological sample suspected of comprising a polynucleotide from the target organism is conveyed into a sample preparation module, and a locus associated with the target organism and a single nucleotide polymorphism (SNP) locus are mixed with a primer set.
The biological sample and the primer set are amplified in an amplification module to produce an output solution containing a first amplicon associated with the locus in a polynucleotide associated with the target organism and a second amplicon comprising the SNP locus. In a detection module, the first amplicon is reacted with a first probe to facilitate production of a first signal indicating the presence of the target organism.
The second amplicon is reacted with a second probe and a third probe to facilitate production of at least one second signal indicating presence of the first target allele associated with resistance to the treatment and a third signal indicating presence of the second target allele associated with susceptibility to the treatment. The second probe has a second probe melting temperature for hybridization to the second amplicon comprising the first target allele, and the third probe has a third probe melting temperature for hybridization to the second amplicon comprising the second target allele, and the second probe melting temperature is lower than the third probe melting temperature.
Claims Coverage
The independent claims cover three inventive features: SNP-locus amplification with allele-specific probe reactions, digital readout of color presence using attenuation-based calculations, and probe binding logic that distinguishes resistance-associated and susceptibility-associated alleles with ordered probe melting temperatures.
Allele-specific detection of resistance and susceptibility SNP alleles with ordered probe melting temperatures
A method that mixes a biological sample with a primer set targeting a locus associated with the target organism and an SNP locus, amplifies the polynucleotide to produce a first amplicon and a second amplicon comprising the SNP locus, reacts the first amplicon with a first probe to facilitate production of a first signal indicating the presence of the target organism, and reacts the second amplicon with a second probe and a third probe to facilitate production of at least one second signal indicating presence of a first target allele associated with resistance and a third signal indicating presence of a second target allele associated with susceptibility, wherein the second probe has a lower melting temperature than the third probe.
Digital read module determination of color presence using attenuation ratio or attenuation difference
A method wherein a digital read module determines the presence of at least one of a second color or a third color based on at least one of a ratio of the third attenuation to the second attenuation or a difference between the third attenuation and the second attenuation.
Probe binding logic for first target allele and second target allele with ordered probe melting temperatures
A method that mixes a biological sample with a primer set targeting a first genetic locus associated with the target organism and a second genetic locus in a polynucleotide associated with an SNP locus, amplifies to produce a first amplicon comprising the first genetic locus and a second amplicon comprising the second genetic locus, reacts the first amplicon with a first probe and reacts the second amplicon with a second probe and a third probe where the second probe binds when the second genetic locus comprises the first target allele and the third probe binds when the second genetic locus comprises the second target allele, and reacts the reagent with at least one of the first amplicon or the second amplicon to facilitate production of a first signal for target organism presence, a second signal for the resistance-associated allele, and a third signal for the susceptibility-associated allele, wherein the second probe has a melting temperature that is lower than the third probe melting temperature.
The independent claims collectively focus on SNP-locus amplification and allele-specific probe reactions that produce signals for target organism presence and for distinguishing resistance-associated versus susceptibility-associated alleles. At least one independent claim specifies digital determination of color presence based on attenuation ratio or attenuation difference.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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