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Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center

CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Pillar Biosciences.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Thursday, October 1, 2026 1 PM-2 PM ET
This presentation will explore the value of in-house CGP, offer insights into the benefits and drawbacks of incorporation, and provide information about important practical factors when considering in-house implementation of CGP.

Webinar presenter Allison M. Cushman-Vokoun, MD, PhD, FCAP, Medical Director, Molecular Diagnostics and Personalized Medicine Laboratory, Director, Division of Diagnostic Molecular Pathology and Human Genetics, Henry F. Krous Professor of Pathology, University of Nebraska Medical Center

CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Illumina.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Tuesday, October 20, 2026 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.

Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology, Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center

CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Roche.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Tuesday, November 3, 2026 1 PM-2 PM ET
Hear an expert discuss the challenges of detecting NRG1 fusions and how RNA-based testing can support more comprehensive fusion identification in clinical practice.

Webinar presenter Benjamin Weinberg, MD, Associate Professor of Medicine and Attending Physician
specializing in gastrointestinal medical oncology

CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Diaceutics.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Subspecialties

Interactive Product Guides

Product Spotlight

Werfen

ACL AcuStar

Company

Werfen

Instrument name

ACL AcuStar

Contact

Annie Lopatin   

City State

Bedford, MA

Phone

800-955-9525

Website

https://www.werfen.com

First year sold

2010

List price/Model type

—/benchtop

Dimensions (H × W × D)/Weight/Instrument footprint

21 × 34 × 24 in./170 lbs./10 sq. ft.

No. of units in clinical use in U.S./Outside U.S.

5/196 (available in most countries)

Composition of installs: Hospital lab/Reference lab/Other

100%/0/0

Targeted daily, monthly, annual test volume

daily: 20–150; monthly: 600–4, 500; annual: 36, 000–54, 000

Operational type

random access

Country where analyzer designed/Manufactured

U.S./U.S.

Company manufactures instrument

no

FDA-approved clotting-based tests

—

FDA-approved chromogenic tests

—

FDA-approved immunologic tests

heparin-induced thrombocytopenia IgG, domain 1, anticardiolipin IgG, anticardiolipin IgM, B2GPI IgG, B2GPI IgM

Other FDA-approved tests

—

User-defined tests in clinical use

—

Tests in development or awaiting FDA 510(k) clearance

ADAMTS13, von Willebrand factor ristocetin cofactor, von Willebrand antigen

Methodologies supported

immunologic (chemiluminescent)

Number of different measured assays onboard simultaneously

20

Number of different assays programmed and calib. at one time

20

No. of user-definable (open) channels/No. active simultaneously

0/0

Factor assays require manual manipulation or dilutions

—

Test throughput per hour/Assay run time

60 (1 test in throughput)/30 min.

Design of sample-handling system

samples loaded into carousel rack

Operates on whole blood or spun plasma

spun plasma

Reagent type

self-contained multiuse cartridges (liquid)

Reagent barcode-reading capability

yes, for all tests

No. of reagent containers held onboard/Reagents ready to use

20/yes

Reagent lot tracking/Reagent inventory/Reagents refrigerated onboard

yes/yes/yes

Reagents, consumables loaded without interrupting testing

yes (reagents and consumables)

Instrument uses proprietary or third-party reagents

proprietary reagents

Maximum time same lot number of reagents can be used

6 months

Walkaway capability/Walkaway duration

yes/30 specimens or 280 tests

Min.–max. specimen volume that can be aspirated at one time

2–250 µL

Min. sample volume required for PT/PTT/Factor VIII activity

50 µL/50 µL/50 µL

Types of disposables used

cuvettes, trigger, solutions

Primary tube sampling supported/Pierces caps on primary tubes

yes/no

Accommodates most standard tube sizes/Nonstandard sizes

yes/no

Sample barcode-reading capability/Autodiscrimination

yes/yes

Auto tracks product volume/Measures number of tests remaining

yes/yes

Short sample detection

yes

Clot detection as preanalytical variable in plasma sample

no

Auto detects adequate reagents for aspiration or analysis

yes (aspiration and analysis)

Detection or quantitation for hemolysis, turbidity, icterus, lipemia 

—

Dilutes patient samples onboard

yes

Automatic rerun capability/Auto reflex testing capability

yes/yes

Lag time during which hypercoagulable sample not detected

—

User can adjust reagent volumes/Sample volumes

no/no

User can adjust No. of reagents/Sources of reagents

no/no

User can adjust incubation times/Reading times

no/no

Autocalibration/Calibrants stored onboard

no/no

Multipoint calibration supported/Recommended frequency

yes/6 months

• PT alone

—

• PT, PTT

—

• Fibrinogen

—

• Factor VIII activity assay

—

• D-dimer

—

Time delay from ordering stat to aspiration of sample

<1 minute

How labs get LOINC codes for results

functionality not provided

Onboard real-time QC/Onboard software capability to review QC

yes/yes

Information that can be barcode-scanned on instrument

specimen identifier, reagent lot No.

Compatible with laboratory automation systems

no

Data-management capability/LIS or EHR systems interfaced

onboard/Meditech

Interface supplied by instrument vendor

contract dependent

Results transferred to LIS as soon as test time complete

yes

Bidirectional interface capability

yes (broadcast download and host query)

Remote servicing provided/UPS backup power supply

no/yes

Instrument connections to transfer information

data-management system, which in turn connects to LIS; directly to LIS; commercial middleware (Werfen, Beckman Coulter)

Interface standards supported

ASTM 1394-91

Information transferred to data-management software

specimen ID

Avg. time for basic user training

4 days (at customer site)

Approximate scheduled maintenance time

daily: 5 minutes; weekly: 5 minutes

Maintenance records kept onboard

yes

Warranty with purchase/Annual service contract cost (24/7)

yes/— (cost dependent on contract)

Distinguishing features (supplied by company)

on-demand heparin-induced thrombocytopenia IgG testing with results available in 30 minutes; uses sensitive chemiluminescent technology, improving sensitivity; reagents are ready to use with onboard stability up to 12 weeks

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