US 11,952,636 B2
Devices and methods for antibiotic susceptibility testing
Brian Ciopyk, Santa Clara, CA (US); Paul Dentinger, Sunol, CA (US); Teresa Abraham, Washington, DC (US); Brandon Ma, Santa Clara, CA (US); Kamal Kajouke, San Jose, CA (US); Mackenzie Hunt, Santa Cruz, CA (US); Austin Phung, San Jose, CA (US); Karl Guegler, Menlo Park, CA (US); David Swenson, Santa Clara, CA (US); and Anna H. Postlethwaite, Longmont, CO (US)
Assigned to Visby Medical, Inc., San Jose, CA (US)
Filed by Visby Medical, Inc., San Jose, CA (US)
Filed on May 6, 2022, as Appl. No. 17/738,979.
Application 17/738,979 is a division of application No. 17/139,451, filed on Dec. 31, 2020, granted, now 11,352,675.
Claims priority of provisional application 62/957,068, filed on Jan. 3, 2020.
Prior Publication US 2022/0372557 A1, Nov. 24, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. C12P 19/34 (2006.01); C12Q 1/04 (2006.01); C12Q 1/18 (2006.01); C12Q 1/689 (2018.01)
CPC C12Q 1/689 (2013.01) [C12Q 1/04 (2013.01); C12Q 1/18 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A molecular diagnostic device, comprising:
a sample preparation module containing a primer set and being configured to mix the primer set with a biological sample to produce an input solution, the biological sample suspected of comprising a polynucleotide from a target organism, the primer set targeting a first genetic locus in a polynucleotide associated with the target organism and a second genetic locus in a polynucleotide associated with a single nucleotide polymorphism (SNP) locus in the polynucleotide;
an amplification module including a reaction volume and a heater, the reaction volume configured to receive the input solution, the heater configured to convey thermal energy into the reaction volume to amplify the polynucleotide to produce an output solution containing a first amplicon comprising the first genetic locus and a second amplicon comprising the second genetic locus;
a detection module including a first probe, a second probe, and a third probe, the first probe designed to bind to the first genetic locus, the second probe designed to bind to the second genetic locus if the second genetic locus comprises a first target allele associated with resistance of the target organism to a treatment, the third probe designed to bind to the second genetic locus if the second genetic locus comprises a second target allele associated with susceptibility of the target organism to the treatment; and
a reagent module containing a reagent formulated to facilitate production of a first signal, a second signal, and a third signal, the first signal indicating the presence of the bound first genetic locus, the second signal indicating the presence of the bound second genetic locus that comprises the first target allele, and the third signal indicating the presence of the bound second genetic locus that comprises the second target allele, wherein
the second probe has a second probe melting temperature for hybridization to the second genetic locus comprising the first target allele,
the third probe has a third probe melting temperature for hybridization to the second genetic locus comprising the second target allele, and
the second probe melting temperature is different from the third probe melting temperature.