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American Association
for Clinical Chemistry


Booth #631  |  Chicago  |  July 29–Aug 2

Bio-Rad

Exhibitor Spotlight Presentation – featuring ddPCR



Droplet Digital PCR and the Power of Partitioning: Advanced Applications for Liquid Biopsy and Single Cell RNA-Seq

Exhibit Hall A – McCormick Place South (Level 3)


Tuesday, April 17th 12:30 PM
Lunch will be served

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (CP199) Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service Deanna Brown, M.T. (ASCP)1, Mandy Madole, M.T. (ASCP)1, Dr. Elizabeth Jack, M.D.1, Melissa J.A. Laufer, BS, BB, SBB (ASCP)2, Marianne M Zollman, MS, MBA2, Candace Williams, MT(ASCP)SBB2 1) Carson Tahoe Regional Medical Center, 2) Bio-Rad Laboratories San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA







Industry Workshop

Raise the Bar: Elevate Staff Training On Key QC Concepts

Wednesday, August 1, 2018 7:00–8:30 AM
Location: Hyatt Regency McCormick Place - Ballroom B
Breakfast reception: 6:30–7:00 AM
CEU Information: Participants will receive 1.5 CEU units

Add to Calendar ▸ 08/01/2018 07:00 AM 08/01/2018 08:30 AM America/Chicago Raise the Bar: Elevate Staff Training On Key QC Concepts We all expect lab staff to have a strong working knowledge of QC, but time and cost constraints limit educational opportunities. When they are well-educated about the logic behind QC processes, data interpretation and application is elevated, leading to overall improved quality performance. Join Bio-Rad for a presentation and panel discussion with three AACC educators who will share practical approaches to QC and their ideas for improving your team's knowledge base. Hyatt Regency McCormick Place - Ballroom A Bio-Rad false 08/01/2018


We all expect lab staff to have a strong working knowledge of QC, but time and cost constraints limit educational opportunities. When they are well-educated about the logic behind QC processes, data interpretation and application is elevated, leading to overall improved quality performance. Join Bio-Rad for a presentation and panel discussion with three AACC educators who will share practical approaches to QC and their ideas for improving your team's knowledge base.



Presenters:

Greg Miller, Ph.D, DABCC
Professor of Pathology
Virginia Commonwealth University Health System
_
_
_


Laura Pamas, PhD, DABCC, FACB
Senior Scientific Affairs Manager
Roche Diagnostics





David Grenache, PhD 
TriCore Reference Laboratories
Chief Scientific Officer, Core Lab Scientific Director



Moderator:

Robert McGonnagle
Publisher
CAP Today
_
_
_



Objectives:

At the completion of the presentation, the audience will be able to:

  • Identify the concepts that AACC educators feel are core to basic QC education
  • Explain the need for a laboratory's QC procedures to be fit for intended use and factors that can render a test unsuitable
  • Share the rationale behind a common QC practice, such as why a rule is selected or the way means and ranges are determined


Register for Workshop




Lecture Series Theater Presentation



Droplet Digital PCR: A Gold Standard for Quantification and Liquid Biopsy Disease Monitoring

Wednesday, August 1, 2018, 11:30–11:50 AM
Location: McCormick Convention Center, Exhibit Hall — Theater 2

Add to Calendar ▸ 08/01/2018 11:30 AM 08/01/2018 11:50 AM America/Chicago Droplet Digital PCR: A Gold Standard for Quantification and Liquid Biopsy Disease Monitoring Personalized cancer care increasingly depends on detecting and monitoring mutPersonalized cancer care increasingly depends on detecting and monitoring mutations in oncogenes and tumor suppressors with extreme sensitivity. Digital platforms like NGS and droplet digital PCR (ddPCR) are being used to identify cancer subtypes, optimize drug treatment plans, monitor residual disease, and study tumor evolution. This information is being used for diagnostic, prognostic, and treatment purposes. Of especial note, ddPCR's increased sensitivity and precision offer critical advantages in the field of liquid biopsies, or non-invasive blood testing. ddPCR easily measures circulating nucleic acids (cfDNA, RNA, or cfRNA) from the blood, and can detect rare tumorigenic mutations in a high background of "normal" DNA, routinely down to 0.01% and often further. Analytical and clinical performance of the BCR-ABL %IS Monitoring kit will be presented as a model of residual disease monitoring in cancer. McCormick Convention Center - Exhibit Hall - Theater 2 Bio-Rad false 08/01/2018


Personalized cancer care increasingly depends on detecting and monitoring mutations in oncogenes and tumor suppressors with extreme sensitivity. Digital platforms like NGS and droplet digital PCR (ddPCR) are being used to identify cancer subtypes, optimize drug treatment plans, monitor residual disease, and study tumor evolution. This information is being used for diagnostic, prognostic, and treatment purposes. Of special note, ddPCR's increased sensitivity and precision offer critical advantages in the field of liquid biopsies or non-invasive blood testing. ddPCR easily measures circulating nucleic acids (cfDNA, RNA, or cfRNA) from the blood, and can detect rare tumorigenic mutations in a high background of "normal" DNA, routinely down to 0.01% and often further. Analytical and clinical performance of the BCR-ABL %IS Monitoring kit will be presented as a model of residual disease monitoring in cancer.



Speaker:

Dawne N. Shelton, Ph.D
R&D Manager for IVD Products, Digital Biology Center
Bio-Rad Laboratories
_ _ _

*Bio-Rad's QX200™ Droplet Digital PCR System is for Research Use Only in the US. Not approved for IVD testing in the US

Exhibitor Spotlight 



Droplet Digital PCR and the Power of Partitioning: Advanced Applications for Liquid Biopsy and Single Cell RNA-Seq

Exhibit Hall A – McCormick Place South (Level 3)


Tuesday, April 17th 12:30 PM
Lunch will be served

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (CP199) Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service Deanna Brown, M.T. (ASCP)1, Mandy Madole, M.T. (ASCP)1, Dr. Elizabeth Jack, M.D.1, Melissa J.A. Laufer, BS, BB, SBB (ASCP)2, Marianne M Zollman, MS, MBA2, Candace Williams, MT(ASCP)SBB2 1) Carson Tahoe Regional Medical Center, 2) Bio-Rad Laboratories San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA




Industry Workshop



Raise the Bar: Elevate Staff Training On Key QC Concepts

Wednesday, August 1, 2018, 7:00–8:30 AM
Location: Hyatt Regency McCormick Place — Regency Ballroom A, Second Floor
Breakfast reception: 6:30–7:00 AM
CEU Information: Participants will receive 1.5 CEU units

Add to Calendar ▸ 08/01/2018 07:00 AM 08/01/2018 08:30 AM America/Chicago Raise the Bar: Elevate Staff Training On Key QC Concepts We all expect lab staff to have a strong working knowledge of QC, but time and cost constraints limit educational opportunities. When they are well-educated about the logic behind QC processes, data interpretation and application is elevated, leading to overall improved quality performance. Join Bio-Rad for a presentation and panel discussion with three AACC educators who will share practical approaches to QC and their ideas for improving your team's knowledge base. Hyatt Regency McCormick Place — Regency Ballroom A, Second Floor Bio-Rad false 08/01/2018


We all expect lab staff to have a strong working knowledge of QC, but time and cost constraints limit educational opportunities. When they are well-educated about the logic behind QC processes, data interpretation and application is elevated, leading to overall improved quality performance. Join Bio-Rad for a presentation and panel discussion with three AACC educators who will share practical approaches to QC and their ideas for improving your team's knowledge base.



Presenters:

Greg Miller, Ph.D, DABCC
Professor of Pathology
Virginia Commonwealth University Health System
_
_
_


Laura Parnas, PhD, DABCC, FACB
Senior Scientific Affairs Manager
Roche Diagnostics
_
_
_


David Grenache, PhD
Chief Scientific Officer, Core Lab Scientific Director
TriCore Reference Laboratories
_
_


Moderator:

Robert McGonnagle
Publisher
CAP Today
_



Objectives:

At the completion of the presentation, the audience will be able to:

  • Identify the concepts that AACC educators feel are core to basic QC education
  • Explain the need for a laboratory's QC procedures to be fit for intended use and factors that can render a test unsuitable
  • Share the rationale behind a common QC practice, such as why a rule is selected or the way means and ranges are determined







Key Poster Presentations 


Tuesday, July 31 | 9:30 AM–5:00 PM

Session: Automation/Computer Applications

Poster #A-043

Implementation of a web-based Quality Control Management System for Clinical Chemistry Laboratories in a Standardized Healthcare System

A. Batista Velazquez et al | Florida Hospital, Orlando, FL

Add to Calendar ▸ 07/31/2018 09:30 AM 07/31/2018 05:00 PM America/Chicago Implementation of a web-based Quality Control Management System for Clinical Chemistry Laboratories in a Standardized Healthcare System A. Batista Velazquez et al/ Florida Hospital, Orlando, FL Poster #A-043 Bio-Rad false 07/31/2018


Session: Factors Affecting Test Results

Poster #A-309

HbA1c Platforms are Variably Affected by Increasing Lipemia

M. L. Parker et al | University of Toronto, Toronto, ON, Canada

Add to Calendar ▸ 07/31/2018 09:30 AM 07/31/2018 05:00 PM America/Chicago HbA1c Platforms are Variably Affected by Increasing Lipemia M. L. Parker et al / University of Toronto, Toronto, ON, Canada Poster #A-309 Bio-Rad false 07/31/2018


Wednesday, August 1 | 9:30 AM–5:00 PM

Session: Infectious Disease

Poster #B-008

Clinical Performance of the Bio-Rad BioPlex 2200 Toxoplasma gondii IgM assay

Melanie L. Yarbrough et al | Washington University School of Medicine, St. Louis, Missouri, USA

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Clinical Performance of the Bio-Rad BioPlex 2200 Toxoplasma gondii IgM assay Melanie L. Yarbrough et al / Washington University School of Medicine in St. Louis, Missouri, USA Poster #B-008 Bio-Rad false 08/01/2018


Poster #B-044

Performance of Bio-Rad Laboratories HIV Quality Controls on the VITROS® Immunodiagnostics Products Combo Assay

William Owens et al | Bio-Rad Laboratories, CA, USA

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Performance of Bio-Rad Laboratories HIV Quality Controls on the VITROS Immunodiagnostics Products Combo Assay William Owens / Bio-Rad Laboratories Poster #B-044 Bio-Rad false 08/01/2018


Poster #B-082

Clinical Performance of the Bio-Rad BioPlex 2200 Syphilis Total and RPR assay

Merih T. Tesfazghi | Washington University School of Medicine in St. Louis, Missouri, USA

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Clinical Performance of the Bio-Rad BioPlex 2200 Syphilis Total and RPR assay Merih T. Tesfazghi/ Washington University School of Medicine in St. Louis, Missouri, USA Poster #B-082 Bio-Rad false 08/01/2018


Session: Molecular Pathology/Probes

Poster #B-248

Quantitative Detection of JAK2-V617F Mutation using Droplet Digital PCR for Molecular Diagnostics of myeloproliferative neoplasms

P. D. R. Cirillo et al | Hermes Pardini Institute (Genetics Division), Vespasiano, Brazil

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Quantitative detection of JAK2-V617F mutation using droplet digital PCR for molecular diagnostics of myeloproliferative neoplasms P. D. R. Cirillo et al / Hermes Pardini Institute (Genetics Division), Vespasiano, Brazil Poster #B-248 Bio-Rad false 08/01/2018






Download full show guide highlighting over 50 customer presentations featuring ddPCR

Key Poster Presentations 


Tuesday, July 31 | 9:30 AM–5:00 PM

Session: Automation/Computer Applications

Poster #A-043

Implementation of a web-based Quality Control Management System for Clinical Chemistry Laboratories in a Standardized Healthcare System

A. Batista Velazquez et al | Florida Hospital, Orlando, FL



Purpose: Human papillomavirus (HPV) is associated with the majority of oropharyngeal squamous cell carcinomas (OPSCC), with a rising incidence of OPSCC predominantly among middle-aged men. Tumor-derived HPV cell-free (cf)DNA can be detected and quantified in circulation with high sensitivity and specificity. Although cfDNA has limited clinical application in monitoring locoregional spread of these tumors, up to 10% of HPV+ OPSCC patients present or recur with distant, metastatic disease. The potential of HPV DNA monitoring in this setting remains largely unexplored.

Methods: We present a proof-of-concept prospective observational cohort of recurrent, metastatic (R/M) HPV+ OPSCC patients treated with standard systemic therapies. We utilized droplet digital (dd)PCR to identify and quantify HPV cfDNA (strains 16, 18, 31, 33 and 45) at multiple time points throughout treatment. We then compared HPV cfDNA concentration at various timepoints with clinical parameters such as disease burden and treatment response.

Results: Clinicopathologic data from 12 R/M patients revealed a predominantly male cohort (11/12, 92%) with a median age of 55 at diagnosis. Eight (67%) were on immunotherapy treatments and the other four on standard chemotherapy during the study period (2.5 months). Plasma HPV cfDNA was detected in 6/12 (50%) samples (range 0-4460 copies/mL) in at least one timepoint during the study. All patients with undetectable HPV cfDNA had evidence of stable, low burden disease or no measurable lesions (near-complete response) on their current therapy. HPV cfDNA levels strongly correlated with both disease burden (p < 0.01) and distant disease sites (p < 0.01). In three cases, HPV DNA levels declined prior to contrast enhanced imaging findings which later confirmed treatment response (up to 14 days prior to planned imaging).

Conclusion: Our results suggest that high sensitivity plasma HPV cfDNA levels can be an early indicator of treatment response. HPV cfDNA monitoring could significantly impact clinical decision-making and improve patient outcomes by informing treatment response or failure. Further studies are underway to validate these findings and determine how early cfDNA can detect metastatic disease.

Add to Calendar ▸ 07/31/2018 09:30 AM 07/31/2018 05:00 PM America/Chicago Implementation of a web-based Quality Control Management System for Clinical Chemistry Laboratories in a Standardized Healthcare System A. Batista Velazquez et al/ Florida Hospital, Orlando, FL Poster #A-043 Bio-Rad false 07/31/2018


Session: Factors Affecting Test Results

Poster #A-309

HbA1c platforms are variably affected by increasing lipemia

M. L. Parker et al | University of Toronto, Toronto, ON, Canada



Purpose: Human papillomavirus (HPV) is associated with the majority of oropharyngeal squamous cell carcinomas (OPSCC), with a rising incidence of OPSCC predominantly among middle-aged men. Tumor-derived HPV cell-free (cf)DNA can be detected and quantified in circulation with high sensitivity and specificity. Although cfDNA has limited clinical application in monitoring locoregional spread of these tumors, up to 10% of HPV+ OPSCC patients present or recur with distant, metastatic disease. The potential of HPV DNA monitoring in this setting remains largely unexplored.

Methods: We present a proof-of-concept prospective observational cohort of recurrent, metastatic (R/M) HPV+ OPSCC patients treated with standard systemic therapies. We utilized droplet digital (dd)PCR to identify and quantify HPV cfDNA (strains 16, 18, 31, 33 and 45) at multiple time points throughout treatment. We then compared HPV cfDNA concentration at various timepoints with clinical parameters such as disease burden and treatment response.

Results: Clinicopathologic data from 12 R/M patients revealed a predominantly male cohort (11/12, 92%) with a median age of 55 at diagnosis. Eight (67%) were on immunotherapy treatments and the other four on standard chemotherapy during the study period (2.5 months). Plasma HPV cfDNA was detected in 6/12 (50%) samples (range 0-4460 copies/mL) in at least one timepoint during the study. All patients with undetectable HPV cfDNA had evidence of stable, low burden disease or no measurable lesions (near-complete response) on their current therapy. HPV cfDNA levels strongly correlated with both disease burden (p < 0.01) and distant disease sites (p < 0.01). In three cases, HPV DNA levels declined prior to contrast enhanced imaging findings which later confirmed treatment response (up to 14 days prior to planned imaging).

Conclusion: Our results suggest that high sensitivity plasma HPV cfDNA levels can be an early indicator of treatment response. HPV cfDNA monitoring could significantly impact clinical decision-making and improve patient outcomes by informing treatment response or failure. Further studies are underway to validate these findings and determine how early cfDNA can detect metastatic disease.

Add to Calendar ▸ 07/31/2018 09:30 AM 07/31/2018 05:00 PM America/Chicago HbA1c platforms are variably affected by increasing lipemia M. L. Parker et al / University of Toronto, Toronto, ON, Canada Poster #A-309 Bio-Rad false 07/31/2018


Wednesday, August 1 | 9:30 AM–5:00 PM

Session: Infectious Disease

Poster #B-008

Clinical Performance of the Bio-Rad BioPlex 2200 Toxoplasma gondii IgM assay

Melanie L. Yarbrough et al | Washington University School of Medicine, St. Louis, Missouri, USA



Purpose: Human papillomavirus (HPV) is associated with the majority of oropharyngeal squamous cell carcinomas (OPSCC), with a rising incidence of OPSCC predominantly among middle-aged men. Tumor-derived HPV cell-free (cf)DNA can be detected and quantified in circulation with high sensitivity and specificity. Although cfDNA has limited clinical application in monitoring locoregional spread of these tumors, up to 10% of HPV+ OPSCC patients present or recur with distant, metastatic disease. The potential of HPV DNA monitoring in this setting remains largely unexplored.

Methods: We present a proof-of-concept prospective observational cohort of recurrent, metastatic (R/M) HPV+ OPSCC patients treated with standard systemic therapies. We utilized droplet digital (dd)PCR to identify and quantify HPV cfDNA (strains 16, 18, 31, 33 and 45) at multiple time points throughout treatment. We then compared HPV cfDNA concentration at various timepoints with clinical parameters such as disease burden and treatment response.

Results: Clinicopathologic data from 12 R/M patients revealed a predominantly male cohort (11/12, 92%) with a median age of 55 at diagnosis. Eight (67%) were on immunotherapy treatments and the other four on standard chemotherapy during the study period (2.5 months). Plasma HPV cfDNA was detected in 6/12 (50%) samples (range 0-4460 copies/mL) in at least one timepoint during the study. All patients with undetectable HPV cfDNA had evidence of stable, low burden disease or no measurable lesions (near-complete response) on their current therapy. HPV cfDNA levels strongly correlated with both disease burden (p < 0.01) and distant disease sites (p < 0.01). In three cases, HPV DNA levels declined prior to contrast enhanced imaging findings which later confirmed treatment response (up to 14 days prior to planned imaging).

Conclusion: Our results suggest that high sensitivity plasma HPV cfDNA levels can be an early indicator of treatment response. HPV cfDNA monitoring could significantly impact clinical decision-making and improve patient outcomes by informing treatment response or failure. Further studies are underway to validate these findings and determine how early cfDNA can detect metastatic disease.

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Clinical Performance of the Bio-Rad BioPlex 2200 Toxoplasma gondii IgM assay Melanie L. Yarbrough et al / Washington University School of Medicine in St. Louis, Missouri, USA Poster #B-008 Bio-Rad false 08/01/2018


Poster #B-044

Performance of Bio-Rad Laboratories HIV Quality Controls on the VITROS Immunodiagnostics Products Combo Assay

William Owens et al | Bio-Rad Laboratories, CA, USA



Purpose: Human papillomavirus (HPV) is associated with the majority of oropharyngeal squamous cell carcinomas (OPSCC), with a rising incidence of OPSCC predominantly among middle-aged men. Tumor-derived HPV cell-free (cf)DNA can be detected and quantified in circulation with high sensitivity and specificity. Although cfDNA has limited clinical application in monitoring locoregional spread of these tumors, up to 10% of HPV+ OPSCC patients present or recur with distant, metastatic disease. The potential of HPV DNA monitoring in this setting remains largely unexplored.

Methods: We present a proof-of-concept prospective observational cohort of recurrent, metastatic (R/M) HPV+ OPSCC patients treated with standard systemic therapies. We utilized droplet digital (dd)PCR to identify and quantify HPV cfDNA (strains 16, 18, 31, 33 and 45) at multiple time points throughout treatment. We then compared HPV cfDNA concentration at various timepoints with clinical parameters such as disease burden and treatment response.

Results: Clinicopathologic data from 12 R/M patients revealed a predominantly male cohort (11/12, 92%) with a median age of 55 at diagnosis. Eight (67%) were on immunotherapy treatments and the other four on standard chemotherapy during the study period (2.5 months). Plasma HPV cfDNA was detected in 6/12 (50%) samples (range 0-4460 copies/mL) in at least one timepoint during the study. All patients with undetectable HPV cfDNA had evidence of stable, low burden disease or no measurable lesions (near-complete response) on their current therapy. HPV cfDNA levels strongly correlated with both disease burden (p < 0.01) and distant disease sites (p < 0.01). In three cases, HPV DNA levels declined prior to contrast enhanced imaging findings which later confirmed treatment response (up to 14 days prior to planned imaging).

Conclusion: Our results suggest that high sensitivity plasma HPV cfDNA levels can be an early indicator of treatment response. HPV cfDNA monitoring could significantly impact clinical decision-making and improve patient outcomes by informing treatment response or failure. Further studies are underway to validate these findings and determine how early cfDNA can detect metastatic disease.

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Performance of Bio-Rad Laboratories HIV Quality Controls on the VITROS Immunodiagnostics Products Combo Assay William Owens / Bio-Rad Laboratories Poster #B-044 Bio-Rad false 08/01/2018


Poster #B-082

Clinical performance of the Bio-Rad BioPlex 2200 Syphilis Total and RPR assay

Merih T. Tesfazghi | Washington University School of Medicine in St. Louis, Missouri, USA



Purpose: Human papillomavirus (HPV) is associated with the majority of oropharyngeal squamous cell carcinomas (OPSCC), with a rising incidence of OPSCC predominantly among middle-aged men. Tumor-derived HPV cell-free (cf)DNA can be detected and quantified in circulation with high sensitivity and specificity. Although cfDNA has limited clinical application in monitoring locoregional spread of these tumors, up to 10% of HPV+ OPSCC patients present or recur with distant, metastatic disease. The potential of HPV DNA monitoring in this setting remains largely unexplored.

Methods: We present a proof-of-concept prospective observational cohort of recurrent, metastatic (R/M) HPV+ OPSCC patients treated with standard systemic therapies. We utilized droplet digital (dd)PCR to identify and quantify HPV cfDNA (strains 16, 18, 31, 33 and 45) at multiple time points throughout treatment. We then compared HPV cfDNA concentration at various timepoints with clinical parameters such as disease burden and treatment response.

Results: Clinicopathologic data from 12 R/M patients revealed a predominantly male cohort (11/12, 92%) with a median age of 55 at diagnosis. Eight (67%) were on immunotherapy treatments and the other four on standard chemotherapy during the study period (2.5 months). Plasma HPV cfDNA was detected in 6/12 (50%) samples (range 0-4460 copies/mL) in at least one timepoint during the study. All patients with undetectable HPV cfDNA had evidence of stable, low burden disease or no measurable lesions (near-complete response) on their current therapy. HPV cfDNA levels strongly correlated with both disease burden (p < 0.01) and distant disease sites (p < 0.01). In three cases, HPV DNA levels declined prior to contrast enhanced imaging findings which later confirmed treatment response (up to 14 days prior to planned imaging).

Conclusion: Our results suggest that high sensitivity plasma HPV cfDNA levels can be an early indicator of treatment response. HPV cfDNA monitoring could significantly impact clinical decision-making and improve patient outcomes by informing treatment response or failure. Further studies are underway to validate these findings and determine how early cfDNA can detect metastatic disease.

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Clinical performance of the Bio-Rad BioPlex 2200 Syphilis Total and RPR assay Merih T. Tesfazghi/ Washington University School of Medicine in St. Louis, Missouri, USA Poster #B-082 Bio-Rad false 08/01/2018


Session: Infectious Disease

Poster #B-248

Quantitative detection of JAK2-V617F mutation using droplet digital PCR for molecular diagnostics of myeloproliferative neoplasms

P. D. R. Cirillo et al | Hermes Pardini Institute (Genetics Division), Vespasiano, Brazil



Purpose: Human papillomavirus (HPV) is associated with the majority of oropharyngeal squamous cell carcinomas (OPSCC), with a rising incidence of OPSCC predominantly among middle-aged men. Tumor-derived HPV cell-free (cf)DNA can be detected and quantified in circulation with high sensitivity and specificity. Although cfDNA has limited clinical application in monitoring locoregional spread of these tumors, up to 10% of HPV+ OPSCC patients present or recur with distant, metastatic disease. The potential of HPV DNA monitoring in this setting remains largely unexplored.

Methods: We present a proof-of-concept prospective observational cohort of recurrent, metastatic (R/M) HPV+ OPSCC patients treated with standard systemic therapies. We utilized droplet digital (dd)PCR to identify and quantify HPV cfDNA (strains 16, 18, 31, 33 and 45) at multiple time points throughout treatment. We then compared HPV cfDNA concentration at various timepoints with clinical parameters such as disease burden and treatment response.

Results: Clinicopathologic data from 12 R/M patients revealed a predominantly male cohort (11/12, 92%) with a median age of 55 at diagnosis. Eight (67%) were on immunotherapy treatments and the other four on standard chemotherapy during the study period (2.5 months). Plasma HPV cfDNA was detected in 6/12 (50%) samples (range 0-4460 copies/mL) in at least one timepoint during the study. All patients with undetectable HPV cfDNA had evidence of stable, low burden disease or no measurable lesions (near-complete response) on their current therapy. HPV cfDNA levels strongly correlated with both disease burden (p < 0.01) and distant disease sites (p < 0.01). In three cases, HPV DNA levels declined prior to contrast enhanced imaging findings which later confirmed treatment response (up to 14 days prior to planned imaging).

Conclusion: Our results suggest that high sensitivity plasma HPV cfDNA levels can be an early indicator of treatment response. HPV cfDNA monitoring could significantly impact clinical decision-making and improve patient outcomes by informing treatment response or failure. Further studies are underway to validate these findings and determine how early cfDNA can detect metastatic disease.

Add to Calendar ▸ 08/01/2018 09:30 AM 08/01/2018 05:00 PM America/Chicago Quantitative detection of JAK2-V617F mutation using droplet digital PCR for molecular diagnostics of myeloproliferative neoplasms P. D. R. Cirillo et al / Hermes Pardini Institute (Genetics Division), Vespasiano, Brazil Poster #B-248 Bio-Rad false 08/01/2018


Customer Presentations 



Abstract Poster Luncheon

Hall E

Saturday, October 7, Noon–2:00 PM


CP199

Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service

Deanna Brown, MT, et al | Carson Tahoe Regional Medical Center

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (CP199) Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service Deanna Brown, M.T. (ASCP)1, Mandy Madole, M.T. (ASCP)1, Dr. Elizabeth Jack, M.D.1, Melissa J.A. Laufer, BS, BB, SBB (ASCP)2, Marianne M Zollman, MS, MBA2, Candace Williams, MT(ASCP)SBB2 1) Carson Tahoe Regional Medical Center, 2) Bio-Rad Laboratories San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA


AP31

Automated Verification of Immunohematology Results and the Impact to Donor Testing

Barbara J. Bachman, MS, MT, SBB, MBB, et al | Bio-Rad Laboratories

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (AP31) Automated Verification of Immunohematology Results and the Impact to Donor Testing Staffing challenges in today’s blood banks require instrumentation with minimal operator intervention, and should include the option of automated result verification. IH-Com™ V5.0, the data management and result interpretation software currently used in the United States for immunohematology testing on the IH-1000™, can analyze reaction images, manage sample, QC and reagent data, and perform automatic result verification. IH-Com V5.0 may be used with a standalone IH-1000, with multiple IH-1000s, and connected to a Laboratory Information System. San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA


AP37

Workflow Comparison of Two Gel Analyzers in a Large Transfusion Service

J. Peter Pelletier, et al | University of Florida College of Medicine

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (AP37) Workflow Comparison of Two Gel Analyzers in a Large Transfusion Service Vendor-assisted workflow studies are becoming more popular as a means to evaluate if immunohematology analyzer capabilities are a match for a specific facility’s needs. The purpose of this study was to evaluate quality, speed and cost workflow properties for the ProVue® (Ortho Clinical Diagnostics) and the IH-1000™ (Bio-Rad Laboratories, Inc.) in a large volume transfusion service using Lean Six Sigma process flow and roadmap. San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA


AP38

Workflow Comparison of Two High Volume, High Throughput Analyzers

Aaron Samson, MBA, MB, et al | Clinical Pathology Labs

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (AP38) Workflow Comparison of Two High Volume, High Throughput Analyzers Few workflow studies have been performed on high volume, high throughput blood bank analyzers in large volume testing facilities. This study was designed to specifically evaluate the operational efficiencies of the Galileo® Neo (Immucor) against the IH-1000™ (Bio-Rad Laboratories, Inc.) using LEAN process flow & Six Sigma methodology. San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA


AP39

Workflow Impact of Automated Result Verification for Patient and Donor Blood Typing

Barbara J. Bachman, MS, MT, SBB, MBB, et al | Bio-Rad Laboratories

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (AP39) Workflow Impact of Automated Result Verification for Patient and Donor Blood Typing Immunohematology facilities face many challenges including standardization, process control, productivity, staffing and patient safety. To alleviate these challenges, the IH-1000™ instrument and complimentary IH-Com™ Data Management System (DMS) were designed to provide lean automation to enhance blood testing facility workflow. The enhanced result management options in IH-Com provides laboratories the ability to automate the release of routine, non-discrepant, acceptable test results to the LIS without operators having to visually inspect all result images. Each facility has flexibility to establish their site-specific result verification rules during system implementation.San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA



Poster sessions 




Abstract Poster Luncheon

Hall E

Saturday, October 7, Noon–2:00 PM


CP199

Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service

Deanna Brown, MT, et al | Carson Tahoe Regional Medical Center

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (CP199) Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service Deanna Brown, M.T. (ASCP)1, Mandy Madole, M.T. (ASCP)1, Dr. Elizabeth Jack, M.D.1, Melissa J.A. Laufer, BS, BB, SBB (ASCP)2, Marianne M Zollman, MS, MBA2, Candace Williams, MT(ASCP)SBB2 1) Carson Tahoe Regional Medical Center, 2) Bio-Rad Laboratories San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA

Poster sessions – featuring ddPCR




Abstract Poster Luncheon

Hall E

Saturday, October 7, Noon–2:00 PM


CP199

Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service

Deanna Brown, MT, et al | Carson Tahoe Regional Medical Center

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (CP199) Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service Deanna Brown, M.T. (ASCP)1, Mandy Madole, M.T. (ASCP)1, Dr. Elizabeth Jack, M.D.1, Melissa J.A. Laufer, BS, BB, SBB (ASCP)2, Marianne M Zollman, MS, MBA2, Candace Williams, MT(ASCP)SBB2 1) Carson Tahoe Regional Medical Center, 2) Bio-Rad Laboratories San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA






Exhibited Products 




Quality Control





Workflow Efficiency Controls



The shape of things to come!
InteliQ is going to be your trusted Bio- Rad, independent Liquichek controls in barcoded, load-and-go tubes, with access to advanced Unity data management tools. This new configuration helps optimize workflow efficiency and improves your risk management.
Learn More at Bio-Rad booth


AMH Control

AMH Control

AMH (anti-Müllerian hormone) Control is a liquid, assayed quality control serum with clinically significant levels for monitoring ovarian reserve test procedures.
Learn More


Molecular Quality Controls

Molecular Quality Controls

Multianalyte Amplichek I, Amplichek II & Amplichek STI monitor the performance of in vitro nucleic acid amplification methods for viral load assays, healthcare associated infections and sexually transmitted infections
Learn more


A1c Testing





D-100 Hemoglobin Testing System

D-100

Fast, high quality system for A1c testing with limited hands-on time providing a thorough review of every result. HPLC system that delivers an A1c result every 45 seconds and includes variant detection.  Suitable for a bench top.  Ideal for mid to high volume laboratories.

* Interferences from common heterozygous hemoglobin variants: HbS, HbC, HbD, and HbE were tested. Based on net performance criteria the results were acceptable.


Learn More


D-10 Hemoglobin Testing System

D-10

Simple and efficient operation, ideal for clinics, physician offices or clinical laboratories. Small footprint system for A1c and B-Thalassemia testing.
Learn More


VARIANT II TURBO Hemoglobin Testing System

VARIANT II TURBO Hemoglobin Testing System

Fully automated HPLC system for A1c testing designed for mid to high volume laboratories. Sysmex trackline version VARIANT II TURBO Link available for laboratories requiring TLA capabilities.
Learn more


Infectious Disease Testing





BioPlex 2200 Syphilis Total and RPR Assay

BioPlex 2200 Syphilis Total and RPR Assay

Fully automated, simultaneous detection of Total (IgG/IgM) antibodies to T. pallidum and RPR antibodies for improved workflow
Learn More


BioPlex 2200 ToRC IgM Assay

BioPlex 2200 ToRC IgM Assay

Simultaneous detection and differentiation of IgM antibodies to T. gondii, Rubella and CMV for determining serological status
Learn More


Geenius HIV 1/2 Supplemental Test



Automated reading and interpretation for confirmation and differentiation of HIV-1 and HIV-2 antibodies 
Learn more


Flow Cytometry



Increase your experimental speed and reproducibility with Bio-Rad's flow cytometers. Our cytometers give researcher's the confidence they need in order to expand their research capabilities.
Learn more






Poster sessions – featuring ddPCR



Saturday, October 7, Noon–2:00 PM


CP199

Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service

Deanna Brown, MT, et al | Carson Tahoe Regional Medical Center

Abstract |  2017-10-07 12:00:00 2017-10-07 14:00:00 America/Los_Angeles (CP199) Evaluation of the IH-1000™ Immunohematology Gel System for Use in a Hospital Transfusion Service Deanna Brown, M.T. (ASCP)1, Mandy Madole, M.T. (ASCP)1, Dr. Elizabeth Jack, M.D.1, Melissa J.A. Laufer, BS, BB, SBB (ASCP)2, Marianne M Zollman, MS, MBA2, Candace Williams, MT(ASCP)SBB2 1) Carson Tahoe Regional Medical Center, 2) Bio-Rad Laboratories San Diego Convention Center – Hall E 111 W Harbor Drive San Diego, CA





Exhibited Products



Quality Control



Workflow Efficiency Controls

AMH Control

Molecular Quality Controls




The shape of things to come!
InteliQ is going to be your trusted
Bio-Rad, independent Liquichek controls in barcoded, load-and-go tubes, with access to advanced Unity data management tools. This new configuration helps optimize workflow efficiency and improves your risk management.  
Learn More at Bio-Rad booth
AMH (anti-Müllerian hormone) Control is a liquid, assayed quality control serum with clinically significant levels for monitoring ovarian reserve test procedures
Learn More
Multianalyte Amplichek I, Amplichek II & Amplichek STI monitor the performance of in vitro nucleic acid amplification methods for viral load assays, healthcare-associated infections and sexually transmitted infections
Learn more


A1c Testing



D-100 Hemoglobin Testing System

D-10 Hemoglobin Testing System

VARIANT II TURBO Hemoglobin Testing System




Fast, high-quality system for A1c testing with limited hands-on time providing a thorough review of every result. HPLC system that delivers an A1c result every 45 seconds and includes variant* detection. Suitable for a bench top. Ideal for mid to high volume laboratories.

* Interferences from common heterozygous hemoglobin variants: HbS, HbC, HbD, and HbE were tested. Based on net performance criteria the results were acceptable.

Learn More
Simple and efficient operation, ideal for clinics, physician offices or clinical laboratories. Small footprint system for A1c and B-Thalassemia testing.
Learn More
Fully automated HPLC system for A1c testing designed for mid to high volume laboratories. Sysmex track line version VARIANT II TURBO Link available for laboratories requiring TLA capabilities.
Learn more


Infectious Disease Testing



BioPlex 2200 Syphilis Total and RPR Assay

BioPlex 2200 ToRC IgM Assay

Geenius HIV 1/2 Supplemental Test



Geenius HIV 1/2 Supplemental Test
Fully automated, simultaneous detection of Total (IgG/IgM) antibodies to T. pallidum and RPR antibodies for improved workflow
Learn More
Simultaneous detection and differentiation of IgM antibodies to T. gondii, Rubella and CMV for determining serological status
Learn More
Automated reading and interpretation for confirmation and differentiation of HIV-1 and HIV-2 antibodies 
Learn more


Blood Bank Testing



IH-1000

TANGO infinity

Flexible, Low-Volume Options
IH-Centrifuge L,
IH-Incubator L




Able to work independently for a minimum of 6–9 hours, allows sample loading whenever you want, and provides its own backup system to ensure fast, automated sample processing at all times.
Learn More
Automates all routine immunohematology testing procedures including blood grouping, antibody screening and identification for patients, donors and cord blood samples.
Learn More
The small but powerful members of the IH‑Complete family allow labs of all sizes to standardize gel and tube applications.
Learn more


Liquid Biopsy Analysis



Droplet Digital PCR*


Liquid biopsy promises a new level of precision in disease profiling and drug resistance monitoring. See how a promising new technology lets you use this method to give clinicians insights that can guide personalized cancer treatments and save lives.
*Bio-Rad's QX200™ Droplet Digital PCR System is for Research Use Only in the US. Not approved for IVD testing in the US
Learn More




Blood Bank Testing





IH-1000



Able to work independently for a minimum of 6— 9 hours, allows sample loading whenever you want, and provides its own back-up system to ensure fast, automated sample processing at all times.
Learn More


Tango infinity

TANGO infinity

Automates all routine immunohematology testing procedures including blood grouping, antibody screening and identification for patients, donors and cord blood samples.
Learn More


Flexible, Low-Volume Options IH-Centrifuge L, IH-Incubator L



The small but powerful members of the IH‑Complete family allow labs of all sizes to standardize gel and tube applications.
Learn more


Liquid Biopsy Analysis





Droplet Digital PCR*



Liquid biopsy promises a new level of precision in disease profiling and drug resistance monitoring. See how a promising new technology lets you use this method to give clinicians insights that can guide personalized cancer treatments and save lives.
*Bio-Rad's QX200™ Droplet Digital PCR System is for Research Use Only in the US. Not approved for IVD testing in the US
Learn More
Add to Calendar ▸ 04/17/2018 12:30 PM 04/17/2018 1:30 PM America/Los_Angeles Bio-Rad Spotlight Presentation – featuring ddPCR™ 12:30– 1:00 PM
A key role for circulating nucleic acids as predictive biomarkers of response in immunotherapy and targeted treatments
Lunch provided
Marzia Del Re, PharmD, PhD
Pharmacogenetics Research Assistant
Clinical Biochemist
Clinical Pharmacology and Pharmacogenetic Unit
Department of Clinical and Experimental Medicine
University Hospital Pisa, Italy

1:00– 1:30 PM
ctDNA as a biomarker for early tumor response assessment in lung cancer patients treated with immunotherapyEd Schuuring, PhD
Full professor in Molecular Oncological Pathology
Senior Clinical Scientist in Molecular Pathology
Department of Pathology (HPC EA10)
University Medical Center Groningen, Netherlands
Exhibit Hall A – McCormick Place South (Level 3) AACR false 04/17/2018


Blood Bank Testing



QX ONE Droplet Digital PCR System

TANGO infinity

QX ONE Droplet Digital PCR System




Able to work independently for a minimum of 6—9 hours, allows sample loading whenever you want, and provides its own back-up system to ensure fast, automated sample processing at all times.
Learn More
Automates all routine immunohematology testing procedures including blood grouping, antibody screening and identification for patients, donors and cord blood samples.
Learn More
The small but powerful members of the IH‑Complete family allow labs of all sizes to standardize gel and tube applications. *Not cleared in the US for gel card use.
Learn more

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