Hologic Genius User manual

Operator’s Manual
Genius™
Image Management Server
Dashboard

Genius ™
Image Management Server
Dashboard User’s Manual
For Use With Version 1.x.y Software MAN-08020-001
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Tel: [phone]
1-508-263-2900
Fax: [phone]
Web: www.hologic.com
Hologic BV
Da Vincilaan 5
1930 Zaventem
Belgium
Australian Sponsor:
Hologic (Australia and
New Zealand) Pty Ltd
Suite 302, Level 3
2 Lyon Park Road
Macquarie Park NSW 2113
Australia
Tel: [phone]

The Genius™ Digital Diagnostics System is a PC-based automated imaging and review system for
use with ThinPrep cervical cytology sample slides. The Genius Digital Diagnostics System is
intended to help a cytotechnologist or pathologist highlight objects on a slide for further professional
review. The Product is not a replacement for professional review. Determination of slide adequacy
and patient diagnosis is at the sole discretion of the cytotechnologists and pathologists trained by
Hologic to evaluate ThinPrep-prepared slides.
© Hologic, Inc., 2021 All rights reserved. No part of this publication may be reproduced, transmitted,
transcribed, stored in a retrieval system, or translated into any language or computer language, in
any form, or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or
otherwise, without the prior written permission of Hologic, 250 Campus Drive, Marlborough,
Massachusetts, 01752, United States of America.
Although this guide has been prepared with every precaution to ensure accuracy, Hologic assumes no
liability for any errors or omissions, nor for any damages resulting from the application or use of this
information.
This product may be covered by one or more U.S. patents identified at
hologic.com/patentinformation
Hologic and Genius are trademarks and/or registered trademarks of Hologic, Inc. in the United
States and other countries. All other trademarks are the property of their respective companies.
Changes or modifications to this unit not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment. Use of the Genius™ Image
Management Server not in accordance with these instructions may void the warranty.
Document Number: AW-22965-001 Rev. 001
3-2021

Genius Digital
Diagnostics System
Genius Digital
Diagnostics System

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 1/13
Genius™ Digital Diagnostics System
Instructions for Use

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 2/13
INTENDED USE
The Genius™ Digital Diagnostics System, when used with the Genius™ Cervical AI algorithm, is
indicated for assisting in cervical cancer screening of ThinPrep® Pap test slides, for the presence
of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous
Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma, as well as
all other cytological categories, including adenocarcinoma, as defined by The Bethesda System
for Reporting Cervical Cytology1.
The Genius Digital Diagnostics System can also be used with ThinPrep® non-gynecological
microscope slides and ThinPrep® UroCyte® microscope slides to provide a digital image of the
whole cell spot for screening.
The Genius Digital Diagnostics System includes the Genius™ Digital Imager, the Genius™ Image
Management Server (IMS), and the Genius™ Review Station. The system is for the creation and
viewing of digital images of scanned ThinPrep glass slides that would otherwise be appropriate
for manual visualization by conventional light microscopy. It is the responsibility of a qualified
pathologist to employ appropriate procedures and safeguards to assure the validity of the
interpretation of images obtained using this system.
For professional use.
SUMMARY AND EXPLANATION OF THE SYSTEM
Slides that have been prepared for screening are loaded into slide carriers which are placed into
the Digital Imager. The operator uses a touch screen on the Digital Imager to interact with the
instrument via a graphic, menu-driven interface.
A slide ID reader scans the slide’s accession ID and locates the position of the cell spot. Then the
Digital Imager scans the entire ThinPrep cell spot, creating an in-focus, whole slide image.
For ThinPrep® Pap test patient sample slides, the Genius Cervical AI algorithm identifies objects
of interest found on the slide. The objects classified as most clinically relevant are presented in a
gallery to a cytotechnologist (CT) or pathologist for review in a gallery of images. The slide image
data, the slide ID and its associated data record are transmitted to the Image Management
Server, and the slide is returned to its slide carrier.
The Image Management Server acts as the central data manager for the Genius Digital
Diagnostics System. As slides are imaged by the Digital Imager and reviewed at the Review
Station, the server stores, retrieves and transmits information based on the case ID.
The CT or pathologist reviews cases at the Review Station. The Review Station is a dedicated
computer running a Review Station software application, with a monitor suitable for diagnostic
review of objects of interest and/or whole slide images. The Review Station is connected to a
keyboard and mouse. When a valid case accession ID has been identified at the Review Station,
the server sends the images for that ID. The CT or pathologist is presented with a gallery of
images of objects of interest for that slide.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 3/13
When any image is being reviewed, the CT or pathologist has the option to electronically mark
objects of interest and include the marks in the slide review. The reviewer always has the option
to move and zoom through a view of the whole slide image, which provides complete freedom to
move any portion of the cell spot into the field of view for examination.
LIMITATIONS
•Only personnel who have been appropriately trained should operate the Genius Digital
Imager or Review Station.
•The Genius Cervical AI algorithm is only indicated for use with the ThinPrep Pap test.
•The laboratory Technical Supervisor should establish individual workload limits for
personnel using the Genius Digital Diagnostics System.
•ThinPrep microscope slides appropriate for the sample type must be used.
•Slides must be stained using the ThinPrep Stain according to the applicable ThinPrep®
Imaging System slide staining protocol.
•Slides should be clean and free of debris before being placed on the system.
•The slide coverslip should be dry and located correctly.
•Slides that are broken or poorly coverslipped should not be used.
•Slides used with the Genius Digital Imager must contain properly formatted accession
number identification information as described in the operator’s manual.
•The performance of the Genius Digital Diagnostics System using slides prepared from
reprocessed sample vials has not been evaluated.
•The monitor and graphics card for the Review Station are those supplied by Hologic
specifically for the Genius Digital Diagnostics System. They are required for proper
performance of the system and cannot be substituted.
WARNINGS
•For In Vitro Diagnostic Use
•The Digital Imager generates, uses, and can radiate radio frequency energy and may
cause interference to radio communications.
•Glass. The Digital Imager uses microscope slides, which have sharp edges. In addition,
the slides may be broken in their storage packaging or on the instrument. Use caution
when handling glass slides and when cleaning the instrument.
•Service Installation Only. The system must be installed by trained Hologic personnel only.
PRECAUTIONS
•Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 4/13
Digital Imager, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
•Care should be taken to assure that slides are correctly oriented in the Digital Imager
slide carrier to prevent rejection by the system.
•The Digital Imager should be placed on a flat, sturdy surface away from any vibrating
machinery to assure proper operation.
PERFORMANCE CHARACTERISTICS
OBJECTS OF INTEREST (OOI) STUDY
A laboratory study was conducted to demonstrate that the Genius Cervical AI algorithm
accurately selects OOIs. An OOI is a cell or cluster of cells on a slide preparation that most likely
contains clinically relevant information for diagnostic purposes. The study compared OOIs
selected by the GeniusCervical AI algorithm to the same samples imaged and reviewed by CTs
using the ThinPrep Imaging System (TIS-assisted review). The study evaluated the performance
of the Genius Cervical AI algorithm to present images suitable for diagnosing abnormal cervical
cases, for detecting the presence of common infectious organisms in a case, and for detecting
the presence of endocervical component (ECC) in a normal case. The study also measured
reproducibility of the Genius Digital Diagnostics System.
In the study, 260 ThinPrep slides were enrolled, made from individual residual ThinPrep Pap test
specimens, covering the full range of abnormal diagnostic categories as defined in The Bethesda
System for Reporting Cervical Cytology. The slides were imaged once on the ThinPrep Imaging
System, and the same slides were imaged three times on three different Genius Digital Imagers.
Slides were reviewed by CTs using the ThinPrep Imaging System (TIS-assisted review), and, after
a washout period, the same CT reviewed the nine runs of that same case on the Genius Digital
Diagnostics System. In each review on the Genius Digital Diagnostics System, the CT recorded
what the CT observed in every tile in the gallery for the case on the Review Station. The CT
reviews were conducted per standard laboratory procedure, recording the diagnostic result, the
presences or absence of endocervical component (ECC) and the presence of any infectious
organisms, such as trichomonas, candida, coccobacillus, for the TIS-assisted review.
The accuracy and reproducibility of the algorithm were measured by comparison to the TIS-
assisted diagnoses. The average and standard deviation across runs leading to the same
diagnosis or higher was the metric used.
OOI Study: Specimen Enrollment
Table 1 shows the nominal enrollment diagnoses (base on donor lab results) for the slides in the
study. In this study there was no independent truth standard, so the study did not measure

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 5/13
absolute accuracy; the study compared TIS-assisted review with the OOIs on the Genius Digital
Diagnostics System.
Table 1. Slides Enrolled in the OOI Study
Category # of slides
NILM 99
ASCUS 6
LSIL 60
ASC-H 8
AGUS 10
HSIL 60
CANCER 16
Study Results: Cervical Cytology Diagnostic Categories
The highest OOI category for any case across the nine runs of the case on the Genius Digital
Diagnostics System was compared to the diagnostic category for the same slide in the TIS-
assisted review. Table 2 shows the relationship between the Genius Digital Diagnostic System
results and the TIS-assisted results.
Table 2. TIS-assisted Results vs. Genius Digital Diagnostic System OOIs
TIS
UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL CANCER Total
OOI
NILM 2 83 4 0 0 2 0 0 91
ASCUS 0 10 6 3 1 0 0 0 20
LSIL 0 0 5 27 0 0 1 0 33
ASC-H 0 1 5 11 2 0 7 0 26
AGUS 0 2 0 0 0 5 1 1 9
HSIL 0 0 2 2 2 1 49 5 61
CANCER 0 0 0 0 1 1 6 9 17
2 96 22 43 6 9 64 15
The study showed an average of 6.8 OOIs in tiles per case on the Genius Digital Diagnostic
System matched the TIS-assisted diagnosis. The standard deviation was 1.3. These results
demonstrate that the Genius Digital Diagnostic System accurately selects OOIs of most interest
for diagnosis. And, the results are repeatable across multiple instruments and multiple runs.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 6/13
Study Results: ECC Detection on Normal Cases
Endocervical component (ECC) presence is noted during slide review to confirm adequate
cellular sampling. ECC consists of either endocervical or squamous metaplastic cells. Because
the Genius Digital Diagnostics cervical cancer algorithm prioritizes the presentation of abnormal
cells when they are present, ECC detection was assessed in this study on the subset of slides
deemed normal (NILM) by TIS-assisted review.
Table 3 shows the relationship of ECC presence on TIS-assisted versus OOI gallery review. In
each case, the “+” or “-” corresponds to ECC present or absent, respectively. The count of slides
in each category is shown in the table.
Table 3. ECC Detection on Normal Cases:
Agreement between TIS-assisted Review and OOI Study Results
ECC TIS
- +
OOI - 4 2
+ 31 59
Agreement
Rates
PPA 97% (89%, 99%)
NPA 11% (5%, 26%)
Detection
Rates
TIS 64% (54%, 72%)
OOI 94% (89%, 99%)
(Diff) -30% (-40%, -20%)
The positive and negative percent agreement (PPA and NPA) were calculated with reference to
the TIS-assisted result. In addition, the detection rates and difference have also been provided.
Confidence intervals for the proportions are calculated using the Newcombe score method and
account for correlation between the matched pairs.
The ECC detection rate for OOI review was 94%, compared to 64% for TIS-assisted review. There
were 31 NILM slides for which ECC was marked as present in the OOI gallery but not noted in
TIS-assisted review. Upon further inspection of those cases, the ECC consisted of rare squamous
metaplastic cells, which were not noted during the TIS-assisted review.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 7/13
Infectious Organism Detection
The presence of infectious organisms is noted as part of slide review to help in the clinical
assessment of the case. In this study, slides were enrolled that included three classes of
organism: Trichomonas, Candida, and Coccobacilli. The tables below compare the detection of
each organism on TIS-assisted review and review of OOIs in the gallery of a Genius Digital
Diagnostic Review Station. For each table, the positive and negative agreement rates with
reference to the TIS-assisted result are provided. The overall detection rate for each organism
and the difference in detection rates (TIS – OOI) are also included.
Table 4. Trichomonas Detection:
Agreement between TIS-assisted Review and OOI Study Results
TRICH TIS
- +
OOI - 246 1
+ 2 8
Agreement
Rates
PPA 89% (57%, 98%)
NPA 99% (97%, 100%)
Detection
Rates
TIS 3.5% (1.9%, 6.5%)
OOI 3.9% (2.1%, 7.0%)
(Diff) -0.4% (-2.5%, 1.6%)
The detection rate for Trichomonas for the Genius Digital Diagnostics System was 3.9%,
compared to 3.5% for TIS-assisted review.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 8/13
Table 5. Candida Detection:
Agreement between TIS-assisted Review and OOI Study Results
CAND TIS
- +
OOI - 232 5
+ 3 17
Agreement
Rates
PPA 77% (57%, 90%)
NPA 99% (96%, 100%)
Detection
Rates
TIS 8.6% (5.7%, 12.6%)
OOI 7.8% (5.1%, 11.7%)
(Diff) 0.8% (-1.8%, 3.4%)
The detection rate for Candida for the Genius Digital Diagnostics System was 7.8%, compared to
8.6% for TIS-assisted review.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 9/13
Table 6. Coccobacilli Detection:
Agreement between TIS-assisted Review and OOI Study Results
COCCO TIS
- +
OOI - 203 5
+ 21 28
Agreement
Rates
PPA 85% (69%, 93%)
NPA 91% (86%, 94%)
Detection
Rates
TIS 12.8% (9.3%, 17.5%)
OOI 19.1% (14.7%, 24.3%)
(Diff) -6.2% (-10.3%, -2.3%)
The detection rate for Coccobacilli for the Genius Digital Diagnostics System was 19.1%,
compared to 12.8% for TIS-assisted review. Further inspection of these cases indicated that
bacteria were indeed present in moderate quantities on some cells. In this study, the CTs were
required to mark the type of each OOI presented, so Coccobacilli would be noted if any normal
cells with bacteria overlaid were presented in the gallery. During a TIS-assisted review, and in
clinical practice, bacterial infection is typically noted only when it is considered of possible clinical
significance (so-called “clue” cells or a large number of infected cells). The difference in detection
rates in the study is due to this difference in counting methodology and would not necessarily be
reflected in clinical practice.
Overall, the presentation of infectious organisms by the algorithm is equivalent or higher than
with TIS-assisted review.
CELL COUNT STUDY
A study was conducted to evaluate the performance of the cell count metric produced by the
Genius Cervical AI algorithm compared to a manual cell count.
ThinPrep Pap test patient sample slides were prepared on a ThinPrep processor, stained and
coverslipped. The same slides were imaged on three Genius Digital Imagers three separate
times. To obtain the manual cell count for the slides in the study, a CT viewed the whole slide
image presented on the Genius Review Station, counted the cells presented in a portion of the
cell spot image, and estimated the total number of cells based on the portion, similar to the
normal process for counting cells on slides viewed on a microscope. The cell counts derived on
each Digital Imager by the algorithm in the Genius Digital Diagnostics system were compared to
the manual cell count estimate.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 10/13
A total of 50 specimens, including at least 8 slides with counts near the clinically critical threshold
of 5000 cells, were enrolled in the study. The slides covered a range of cellularity typical of a
clinical environment. Figure 1 compares the cell counts between the Genius Cervical AI algorithm
and a manual cell count method for each specimen.
Figure 1: Deming Regression
Cell Count: Digital Imager vs. Manual
Manual cell count
Digital Imager cell count
Cell counts

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 11/13
The study calculated the average cell count generated by the Genius Cervical AI algorithm
for each case across the three runs on each of the three Digital Imagers in the study. The
intra-instrument %CV in the study was 0.6%. The inter-instrument %CV in the study was 2.7%.
The study also estimated the systematic bias of the cell count generated by the Genius
Cervical AI algorithm as compared to the manual count, at a count of 5000 cells, the clinical
threshold for diagnosis. In the Bethesda System1, specimens with fewer than 5000 cells are
considered unsatisfactory for screening. The count bias in the study was 528, with a 95% CI
of -323 to 1379.
The results of the study demonstrate that the cell counts generated by the Genius Cervical
AI algorithm are comparable to a manual cell count performed by a cytotechnologist.
CONCLUSIONS
•89.3% of abnormal slides have OOIs matching or exceeding the TIS-assisted review result.
•On average, there are 6.8 OOIs that match or exceed the TIS-assisted result for abnormal
slides.
•The standard deviation of number of matching OOIs is 1.3, for abnormal slides.
•Endocervical component (ECC) is detected in the OOI gallery at an equal or higher rate
than in TIS-assisted reviews.
•Trichomonas is detected in the OOI gallery at an equal or higher rate than in TIS-assisted
reviews.
•Candida is detected in the OOI gallery at an equal or higher rate than in TIS-assisted
reviews.
•Coccobacilli are detected in the OOI gallery at an equal or higher rate than in TIS-assisted
reviews.
•The Genius Digital Diagnostics System provides cell counts adequate for determining if
specimen adequacy is sufficient for evaluating patient cases.
The data from the studies conducted on the Genius Digital Diagnostics System demonstrate that
the Genius Digital Diagnostics System, when used with the Genius Cervical AI algorithm, is
effective for assisting in cervical cancer screening of ThinPrep® Pap test slides, imaged on the
Genius Digital Imager for the presence of atypical cells, cervical neoplasia, including its precursor
lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial
Lesions), and carcinoma as well as all other cytological criteria, including adenocarcinoma, as
defined by The Bethesda System for Reporting Cervical Cytology1.

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 12/13
MATERIALS REQUIRED
MATERIALS PROVIDED
•Genius Digital Imager
oDigital Imager
oDigital Imager computer
oSlide carriers
•Genius Review Station
oMonitor
oReview Station computer*
•Genius Image Management Server
oServer*
oNetwork switch
*In some configurations of the system, the laboratory may supply the Review Station
computer into which Hologic installs a Hologic-supplied graphics card. In some configurations
of the system, a laboratory may supply the server hardware.
MATERIALS REQUIRED BUT NOT PROVIDED
•Slide staining racks
•Monitor, keyboard, mouse for the Image Management Server
•Keyboard and mouse for each Review Station
STORAGE
•Refer to the Technical Specifications included in the Digital Imager operator’s manual.
•Additional storage requirements may apply. Refer to the documentation provided with the
server, monitors and computers.
BIBLIOGRAPHY
1. Nayar R, Wilbur DC. (eds), The Bethesda System for Reporting Cervical Cytology:
Definitions, Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015

Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 13/13
TECHNICAL SERVICE AND PRODUCT INFORMATION
For technical service and assistance related to use of the Genius Digital Diagnostics System,
contact Hologic:
Telephone: [phone]
Fax: [phone]
For international or toll-free blocked calls, please contact 1-508-263-2900.
Email: [email protected]
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752
1-800-442-9892
www.hologic.com
Hologic BV
Da Vincilaan 5
1930 Zaventem
Belgium
©2021 Hologic, Inc. All rights reserved.

Table of Contents
Table of Contents

Genius™ Image Management Server User’s Manual i
Table of Contents
Contents
Chapter One
Introduction
Overview .......................................................................................1.1
The Genius Digital Diagnostics System ....................................1.2
Image Management Server Technical Specifications...............1.5
Internal Quality Control ..............................................................1.7
Genius Image Management Server Hazards............................1.8
Disposal........................................................................................1.11
Chapter Two
Installation
General ...........................................................................................2.1
Action upon Delivery...................................................................2.1
Preparation prior to Installation.................................................2.2
Moving the Image Management Server....................................2.3
Connecting Image Management Server Components ............2.3
Power on the Server .....................................................................2.4
Storage and Handling - Post Installation..................................2.5
System Shutdown.........................................................................2.5
Chapter Three
Image Management Server Dashboard
Overview .......................................................................................3.1
System ............................................................................................3.2
Archiver and Retriever ................................................................3.4
Review Station ............................................................................3.10
Network .......................................................................................3.11

ii Genius™ Image Management Server User’s Manual
Time Server..................................................................................3.12
Imager Service.............................................................................3.13
ThinPrep DB................................................................................3.14
Settings .........................................................................................3.18
Chapter Four
Maintenance...............................................................................................4.1
Chapter Five
Troubleshooting ........................................................................................5.1
Red Status Indicator on System Dashboard .............................5.1
Chapter Six
Service Information..................................................................................6.1
Chapter Seven
Ordering Information ..............................................................................7.1
Index