US 12,444,483 B2
Qualification of sequencing instruments and reagents for use in molecular diagnostic methods
Samuel V. Angiuoli, Baltimore, MD (US); and David Riley, Baltimore, MD (US)
Assigned to PERSONAL GENOME DIAGNOSTICS INC., Baltimore, MD (US)
Filed by PERSONAL GENOME DIAGNOSTICS INC., Baltimore, MD (US)
Filed on Jan. 6, 2020, as Appl. No. 16/735,517.
Claims priority of provisional application 62/845,564, filed on May 9, 2019.
Claims priority of provisional application 62/789,421, filed on Jan. 7, 2019.
Prior Publication US 2020/0219594 A1, Jul. 9, 2020
Int. Cl. G16H 10/40 (2018.01); G01N 35/00 (2006.01)
CPC G16H 10/40 (2018.01) [G01N 35/00712 (2013.01); G01N 35/00871 (2013.01); G01N 2035/00673 (2013.01)] 21 Claims
OG exemplary drawing
 
1. A system comprising:
a memory configured to store identifiers of sequencing apparatuses and associated statuses of the sequencing apparatuses, identifiers of reagents and associated statuses of the reagents, and identifiers of approved software for the sequencing apparatuses;
a network interface configured to communicate with a sequencing apparatus and a client terminal; and
a processor configured to:
receive a report from the sequencing apparatus via the network interface for a sequencing run performed on the sequencing apparatus, wherein the report comprises an identifier of the sequencing apparatus, an identifier of a reagent used in the sequencing run, an identifier of software installed in the sequencing apparatus, and a result of the sequencing run;
determine whether the sequencing run is designated as a qualification run based on a user designation in a user interface or an analysis plan;
when it is determined that the sequencing run is designated as the qualification run, the processor is further configured to:
compare the identifier of the software in the report with the identifiers of the approved software in the memory, wherein
when there is no match between the identifier of the software in the report and the identifiers of the approved software in the memory, the software installed in the sequencing apparatus is determined to be not approved, and the associated status for the sequencing apparatus or the reagent is determined to be unqualified, and;
when there is a match between the identifier of the software in the report and the identifiers of the approved software in the memory, the software installed in the sequencing apparatus is determined to be approved, and the result of the sequencing run is examined to determine whether the sequencing apparatus or the reagent is qualified; and
update the associated status in the memory for at least one of the sequencing apparatus and the reagent in response to examination;
when it is determined that at least one of the sequencing apparatus and the reagent is qualified, the processor is further configured to transmit via the network interface a notification to the client terminal that (i) the sequencing apparatus is qualified when the sequencing apparatus is determined to be qualified, and (ii) the reagent is qualified when the reagent is determined to be qualified; and
when it is determined that the at least one of the sequencing apparatus and the reagent is unqualified, the processor is further configured to:
(i) transmit via the network interface a notification to the client terminal that the sequencing apparatus is unqualified when the sequencing apparatus is determined to be unqualified, and
cause a selection of a diagnostic mode analysis using the sequencing apparatus to be disabled on the client terminal; and
(ii) transmit via the network interface a notification to the client terminal that the reagent is unqualified when the reagent is determined to be unqualified, and
update the analysis plan by removing the reagent from a list of available reagents to be included in the analysis plan from a location where the analysis plan is stored.