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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 

BIO-FLASH

Company

Werfen 

Name of instrument

BIO-FLASH

Email

AID.marketing.na@werfen.com

City, State

San Diego, CA

Phone

858-586-9900   

Website

http://www.werfen.com

Type of instrument

immunoassay

List price/First year sold in U.S.

—/2012

Targeted hospital bed size/Targeted test volume

—

Company manufactures instrument

yes

Other models in this family of analyzers

—

No. of units in clinical use in U.S./Outside U.S. (countries)

—/1,000

Dimensions (H × W × D)/Instrument footprint

21 × 34 × 24 in./—

Weight empty/Weight fully loaded

170 lbs./—

No. of different measured assays onboard simultaneously

20 (20 can be run and calibrated at one time)

No. of user-definable (open chemistry) channels

0

Test throughput per hour/Assay run time

60 (60 tests in throughput)/30 min.

No. of direct ion-selective electrode channels

—

Detection methods

—

Stat time until completion/specimen throughput for Ion-selective electrode

—

Stat time until completion/specimen throughput for Ion-selective electrode basic metabolic panel

—

Stat time until completion/specimen throughput for Ion-selective electrode complete metabolic panel

—

Typical time delay from ordering stat test until aspiration of sample

—

Fully automated microplate immunoassay system

no

Methodologies supported

chemiluminescence

Separation methodologies

magnetic particle, bead

Stat time until completion of a ß-hCG test

—

Stat time until completion of a cTn test

—

• Typical time delay from test order to aspiration of sample

—

Reagents refrigerated onboard/Reagents ready to use

yes/yes

Reagent lot tracking/Reagent inventory

yes/yes

Reagent form/Reagents barcoded

liquid chemistry (closed reagent system)/yes

Separate reagent pack for each specimen/for each test run

no/yes

Walkaway capability/Walkaway duration

yes/30 specimens or 140 tests

Design of sample-handling system

rack

Uses washable cuvettes/Uses disposable cuvettes

no/yes (can store up to 280 cuvettes)

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

4–250 µL

Min. reaction volume/Min. specimen volume/Min. dead volume

20 µL/5 µL/200 µL

Dedicated pediatric sample cup

yes

Primary tube sampling

yes

Accommodates most standard tube sizes/Accepts nonstandard tube sizes

yes/no

Pierces caps on primary tubes

no

Protects against probe collision

no

Detects clots/liquid level/short sample

yes/yes/yes

Detection or quantitation for hemolysis, icterus, lipemia, clots

—

Dilutes patient samples onboard/Susceptibility to carryover

yes (can be programmed to perform dilutions prior to analysis)/—

Automatic rerun capability

yes

Sample volume can be diluted to rerun out-of-linear-range high results

yes

Sample volume can be concentrated to rerun out-of-linear-range low results

no

Autocalibration/Multipoint calibration supported

no (calibrants are not stored onboard)/yes

Typical calibration frequency for ISE/therapeutic drugs/drugs of abuse/general chemistries/immunoassays

—/—/—/—/once per year

Automatic programmable start/Automatic programmable shutdown

yes (5 min. warm-up time)/yes

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

yes/yes

Supports multiple QC lot numbers per analyte

no

Waste management

automated collection onboard instrument or direct to drain

Sample barcode-reading capability/Autodiscrimination

yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes

Lab can control analyzer from remote computer

no

Instrument can diagnose its own malfunctions

no (operator intervention required to order parts)

System malfunctions can be diagnosed via remote monitoring

no

UPS backup power supply

yes

Data-management capability/LIS or EHR systems interfaced

onboard/—

LIS interface provided/Bidirectional interface capability

no/yes (broadcast download and host query)

Modem servicing provided/Service engineer on-site response time

no/24 hrs.

Mean time between failures

— (displays error codes for troubleshooting)

Average scheduled maintenance time by lab personnel

daily: performed automatically; weekly: 5 min.; monthly: 15 min.

Maintenance records kept onboard for user/vendor

some records/some records

Maintenance training demonstration module onboard

no

Training included with purchase/Avg. time for basic user training

yes/3 hrs. (at customer site)

Advanced operator training/Extra charge for follow-up or advanced training

yes (at customer or vendor site)/—

Warranty provided/Cost of annual service contract (24 h/7 d)

yes/—

Distinguishing features (supplied by company)

improves laboratory workflow and productivity; eliminates batching and reagent waste with stable onboard reagents; provides simultaneous random-access processing of all isotypes and assays from one sample on a single run; delivers results, including stat orders, in as little as 30 minutes; minimal hands-on time for user maintenance

Note

all information listed was provided to CAP TODAY in 2025; company did not provide updated information by 2026 entry deadline

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