Devices and methods for antibiotic susceptibility testing
Inventors
Swenson, David • CAO, Phoebe • Schoolnik, Gary • KNYSH, Bryan D. • ABRAHAM, Teresa M.
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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-12239993-B2
Publication Date
2025-03-04
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 bacterial infections. In other aspects, the disclosure provides methods of treatment for disease or disorders (e.g. bacterial 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 relates to a molecular diagnostic device for detecting a drug-resistance allele within a polynucleotide by SNP locus discrimination. The device includes a sample preparation module configured to receive a biological sample comprising a polynucleotide, a reagent module containing a primer set targeting a single nucleotide polymorphism (SNP) locus, and an amplification module that amplifies the polynucleotide to produce a target amplicon containing the SNP locus.
The detection module receives the target amplicon and includes a probe configured to bind the SNP locus of the target amplicon if the SNP locus comprises a target allele, while minimizing binding if the SNP locus comprises an alternative allele. The target allele is a drug-resistance allele, and the molecular diagnostic device specifically detects the drug-resistance allele in the biological sample.
The disclosed embodiments include gyrA SNP allele discrimination, including the gyrA 91 locus and the Ser-91/Phe-91 site associated with ciprofloxacin-sensitive and ciprofloxacin-resistant genotypes. The assay is described as avoiding reliance on melting-curve analysis, and the probe and primer design are configured for allele discrimination using thermodynamic evaluation and intentional mismatches to minimize cross-binding.
Claims Coverage
Independent claim coverage centers on 5 inventive features: sample preparation of a biological sample comprising a polynucleotide, amplification of an SNP locus using a primer set targeting the SNP locus, detection using a probe that preferentially binds the target allele while minimizing binding to an alternative allele, and specific detection of a drug-resistance allele.
Snp locus targeted sample preparation for polynucleotide amplification
A sample preparation module configured to receive a biological sample comprising a polynucleotide.
Primer set targeting a single nucleotide polymorphism locus
A reagent module containing a primer set targeting a single nucleotide polymorphism (SNP) locus in the polynucleotide.
Heated amplification module producing output containing SNP locus amplicon
An amplification module configured to amplify the polynucleotide to produce a target amplicon comprising the SNP locus.
Allele-specific probe minimizing cross-binding to alternative alleles
A detection module including a probe designed to bind to the SNP locus of the target amplicon if the SNP locus comprises a target allele, while minimizing binding if the SNP locus comprises an alternative allele.
Drug-resistance allele detection at the SNP locus
The molecular diagnostic device wherein the target allele is a drug-resistance allele, and the device specifically detects the drug-resistance allele in the biological sample.
The claim set centers on amplifying a single SNP locus from a polynucleotide in a biological sample and detecting a drug-resistance allele at that SNP locus using a probe engineered to preferentially bind the target allele while minimizing binding to an alternative allele.
Stated Advantages
Specifically detects a drug-resistance allele in the biological sample by preferential probe binding at the SNP locus.
Minimizes probe binding to the SNP locus when the SNP locus comprises an alternative allele.
Discriminates ciprofloxacin-sensitive Ser-91 genotype and ciprofloxacin-resistant Phe-91 based on SNP locus composition.
Documented Applications
Detecting susceptibility versus resistance associated with a drug, including antibiotic choice, by identifying drug-resistance or drug-sensitivity alleles at an SNP locus.
Point-of-care molecular diagnostic for antibiotic susceptibility testing using amplification of a SNP locus and discrimination of target versus alternative alleles to support genotype-guided treatment decisions, including ciprofloxacin susceptibility and drug-resistance detection.
Assay use for Neisseria gonorrhoeae in an NG/gyrA SNP context, discriminating ciprofloxacin-sensitive and ciprofloxacin-resistant genotypes at the gyrA Ser-91/Phe-91 site.
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