Abbott Diagnostics Company and Product Overview

Abbott Diagnostics
Company and Product Overview

Abbott Diagnostics Mission:

· To improve lives by providing cost-effective health care products and services

Abbott Diagnostics Vision:

u To be the world's primary source of diagnostic tests.

u Day-to-day efforts are guided by the following four priorities:

u Continually improve the quality of patient care

u Provide exceptional service to the medical community

u Create a positive working environment for employees

u Maintain a healthy growing business

Global Presence:

u Abbott Laboratories is ranked 133 of Fortune 500 companies, has 56,000 employees in 150 countries worldwide and revenues of $12.5 billion.

u Greater than $1 billion per year is devoted to the research and development of innovative health care solutions in the following areas:

u Pharmaceuticals

u Diagnostics

u Hospital Products

u Nutrition

u Chemical and Agriculture

u Abbott Diagnostics focused on advances in areas of

u Immunodiagnostics

u Hematology

u Blood Glucose Monitoring

u DNA testing

Positioning Statement:

u The goal in diagnostics is to help lower the overall cost of health care by developing tests and systems that provide early, accurate detection and management of medical conditions.

Hematology Strategy against Coulter:

u Create the perception that Coulter has "old" technology

u Position optical counting as being more accurate and precise

u Use the strength of Abbott Diagnostics products by bundling additional laboratory products - especially immunoassay

u Use the strength of Abbott Laboratories by bundling hospital and pharmaceutical products

u Use national contracts (eg. Premier)

Product Breadth and Depth:

Abbott Cell-Dyn hematology portfolio consists of 6 primary instruments (5 platforms):

u Cell-Dyn 1700

u Cell-Dyn 3200

u Cell-Dyn 3500R

u Cell-Dyn 3700

u Cell-Dyn 4000

u Cell-Dyn SlideMaker/Stainer (SMS)

u The only thing consistent about the Cell-Dyn's platform technology is their inconsistency. For example:

u CD 4000 is impedance, optical & fluorescence

u WOC, RIC, ROC, PIC & POC

u CD 3000, 3500, 3700 are impedance and optical

u WOC, RIC, & PIC (3500, 3700 adds WIC, 3700 also has NIC)

u CD 3200 is purely optical

u WOC, NOC, ROC & POC

u CD 1400, 1500, 1600 & 1700 are impedance

u WIC, RIC, & PIC

u However, Abbott effectively uses a the derivative product approach

u The 3700 is an updated 3500

Abbott's Targets:

Abbott's primary targets will be every laboratory performing hematology testing. Their overwhelming presence in the hospital as well as in laboratory (especially immunoassay) combined with the shear number of accounts representatives and specialists means that every account is a potential target. However, the aged base of CD3000's and ABC accounts will have a special emphasis.

SWOT Analysis

Abbott Diagnostics
CAP Comparisons: COULTER® HmX vs. CD3200

The following table is a modification to information originally presented in CAP TODAY, Dec. 1998. Modifications were made to both the HmX and CD3200 information in the interests of

completeness.

Instrument Name / COULTER® HmX™ /

Abbott CD3200

/
First Yr. Sold / 1999 HmX A/L
1999 HmX CP / 1997
Test Menu/Chartable / WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, PLT, MPV, lymph #&%, mono #&%, neut #&%, eo #&%, baso #&%, retic #&%, graded RBC morphology*
*Not available on the CD3200 / WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, PLT, MPV, neut #&%, mono #&%, lymph #&%, eo #&%, baso #&%
Test Menu/Flags / Comprehensive high/low, definitive and suspect messages / Band, blast, variant lymph, IG, NRBC, RRBC, NWBC, FWBC
Tests not available but sub for 510K clearance / MRV, IRF *
*Not available on the CD3200 / N/A
Other tests under development / N/A / Retic #, %, IRF
Tests used clinically outside US / PCT, PDW / PCT, PDW
Differential method(s) / Coulter's 3-D VCS technology / M.A.P.S.S.b (Multi-angle Polarized Scatter Separation
WBC method(s) / Impedance / Dual gated optical scatter
Hemoglobin method / Modified Cyanmethemoglobin / Cyanide-free colorimetric determination
Red blood cell/platelet method / Impedance / Hydrodynamic focused flow gated optical
Linearity/WBC count (109/L) / 0-99.9 / 0-250
Linearity/RBC count (1012/L) / 0-7.0 / 0-8
Linearity/Hemoglobin (g/dL) / 0-25 / 0-25
Linearity/MCV(fl)or Hct(%) / 50-150 (MCV) / 35-180 (MCV)
Linearity/Platelet / 0-999 / 0-1750
Precision/WBC count / <2.5% / <2.7%
Precision/RBC count / <2.0% / <1.5%
Precision/Hemoglobin / <1.5% / <1.0%
Precision/MCV or Hct / <2.0% (MCV) / <1.0% (MCV)
Precision/Platelet / <5.0% / <4.0%
Accuracy of automated diff compared with manual diff, per NCCLS H-20A / Lymph%=+3.0%, neut%=+2.0%, eo%=+1.0%, baso%=+1.0% / Neut #&%: >.95, lymph #&%: >.94, mono #&%: >.86, eo #&%: >.84, baso #&%: >.73
Interfering substances/WBC / Unusual RBC abnormalities that resist lysing, NRBC, fragmented WBC, any unlysed particle >35 fL, very large PLT / NRBCs, lytic-resistant RBCs, PLT clumps, cryoglobulin & cryofibrinogen, fragile WBCs
Interfering substances/RBC count / Very high WBC, high conc. of very large PLT, auto-agglut / Elevated WBC count, increased nos. giant PLTs, auto-agglut, in vitro hemolysis
Interfering substances/Platelet / Very small eryth. Or leuk., or cell fragments may cause no-fit. Chemotherapy may affect certain samples. / WBC frags., in vitro hemolysis, microcytic RBCs, cryoglobs, PLT clumping, increased nos. giant PLTs
Interfering substances: differential / High triglycerides may affect lysing / N/A
Number normal ranges for sample comparison / 1 / Patient limit sets: 6
Throughput/max CBCs/hr / 75/hr / 70/hr
Throughput/max CBCs & diff/hr / 75/hr / 70/hr
Throughput Retics/hr / 30 /hr / N/A
Microsample capability / Yes / Yes
Recommended average calibration frequency / 2 times/yr. / 6 mos verification
Modes calibrated / Primary / Open &/or closed
Parameters calibrated / WBC, RBC, Hgb, MCV, PLT, MPV / WBC, RBC, Hgb, MCV, PLT
Recommended frequency of blood controls / Once per shift / 2 levels every 8 hrs
Frequency of latex controls / Once per day / N/A
Min specimen volume open/closed / 125 µL/185 µL/50 µL predilute / 120 µL/250 µL
Sample dead volume closed / 0.5 mL / 1 mL (sample loader)
Tube sampling supported / Yes / Yes
Quality control features/Controls / 100 runs/file / X-B, SD, CV, Westgard, L-J graphs, Cell-Dyn Series Controls
Quality control features/Patient / Any QC control file / X-B, MCV, MCH, MCHC, diff-neut & lymph
Quality control features/Method redundancy / Triplicate Counting / WBC optical count (WOC)/nucleated optical count (NOC)
Quality control features/Other / XB analysis / Internal QC programs
Closed vial controls & disk loading assay values / Yes / No
Archives patient data for later comparison / Yes / Yes
Max archived data accessible when system on line / 5,000 results on line, 1,000 numeric results archived to diskette / 10,000 samples
# numeric results saved in memory at any time / 5,000 with retics / 10,000 (all results)
# graphic results saved in memory at any time / 5,000 with retics / 10,000 results, with scatterplots & histograms
Performs Delta checks / No / No
Saved results can be recalled and retransmitted / Yes / Yes
How long information is retained / 5,000 samples, FIFO / 10,000 samples, FIFO
Histogram/cytogram results stored / Yes / Yes
Saved data can be sorted for reprocessing or report transmission / Yes / Yes
Data management capability integrated / Yes / Yes
Size of patient medical record field / 12 characters / 12 characters
Tags and holds result for follow up or confirmatory test or rerun / Yes / No
Parameters for flags for holding samples defined by / User & vendor / N/A
When results held for follow-up, some can be transmitted others held / Yes, through a selective batch process / Yes
Bi-directional interface capability / Yes / Yes
Bar code symbologies / Codabar, Code 39, Code 128, Interleaved 2 of 5, NW-7 / Codabar, Code 39, Interleaved 2 of 5
Scattergram display: Cell-specific color / 4 colors/cell types / Yes
Histogram display: color with thresholds / Colors without thresholds / Yes
Choice of specimen and/or result info displayed / Yes / Yes
Prepares micro slides auto or flags problems for slide prep / Yes / Yes
Interfaces to auto lab transportation system / No / Yes
Accessories available / N/A / Yes
Units installed in US/outside US/list price / $135,000 A/L/$120,000 CP / >250/>400/$155,000-$165,000
Acquisition program based on cost-per-reportable result / Yes / Yes
Complexity rating/510(k) status / Moderate/Cleared / Moderate/Cleared
Differential sample stability (RT) / Up to 24 hours / 8 hours
Auto start load and walkaway / Yes - SmartStart™ / No
Maintenance / Zero daily routine maintenance / Extensive
Point of aspiration positive bar code ID / Yes / No
Integrated autoloader and bar code reader / Yes / No
Immediate STAT / Yes / No

Abbott
So they say . . . : COULTER® HmX vs. CD3200

What Abbott is saying:

It’s amazing how often people are prepared to accept things at face value from our competitors, but seldom from us. Why is that? It’s probably that we haven’t given you the right information – this section addresses the issue. No claim from a competitor should be left unchallenged. We must place the burden of proof back on them, for if we allow the claim to stand, we ADD to its credibility.

Abbott says… / Truth is… /
Laser technology is new and exciting- Coulter has old technology
Target: Pathologists, Lab Managers / Yes, the CD3200 is laser based for counting and sizing. However, the Coulter TPS (Two Population Sorter marketed in Europe by Coulter) was the first instrument to utilize laser light scatter. Even Ortho used this technology in the ELT8 back in 1980. So the use of a laser is neither new or exciting. The newest technology introduced to the market was in 1987 - when Coulter introduced the VCS. Coulter has always used advanced and proven technologies to perform CBCs and differentials. The funny thing is, Abbott seems to be just realizing this. How do we know? Just take a look at their new CD3700 brochure - it refers to two advanced technologies, that of proven impedance and high resolution flow cytometry.
Cell-Dyn 3200 has a more accurate WBC count and differential
Target: Lab Manager, Technologists / Abbott says their WBC is better because they use two independent laser counts (WOC and NOC). The HmX uses three independent impedance counts (triplicate counting) - the reference method for counting and sizing particles. However, the one thing that is true is that the WBC linearity range on the CD3200 is higher than the HmX. Abbott also states that it has no interference from NRBCs or non WBC (eg. Platelet clumps) and automatically corrects for NRBCs. The reality is that the CD3200 does have interference and flags for NRBCs, NWBCs and RRBCs (see reference material - CD3200 Flags). If the flag is present, the operator is told to Review stained smear. So much for no interference! (By the way - if you have a difficult time finding the flag - it is located next to the MONO%). As for the automatic WBC correction, this is based on the % of cells below the WBC threshold on the 00/100 scatter plot (the region for stroma). (see reference material - CD Scatter Plots) Can you really assume that all cells are NRBCs, or that all fall below the threshold? The obvious potential is for over or under correction of the white count. The phrases "no interference" and automatic correction of NRBCs" sounds good, but if the technologist still has to review the smear and check the histogram - where is the actual time saving or benefit to the customer?
Coulter has too many flags
Target: Lab Manager, Technologists / The old technology story isn't working any more, so Abbott has changed tactics. Now they are attacking the flags on the HmX. The reality is that the CD3200 has a multitude of flags - both Suspect Parameter and Suspect Population Flags (see reference material - CD3200 flags). However, the flags show up in interesting places. For example, Platelet flags indicating interference either in the upper or lower threshold region (URI or LRI flags) tell the customer to Review stained smear. However, the flag will be displayed next to the MPV result, not next to the PLT result. Also, watch out for the DFLT flag - this flag will use a default value or threshold to determine the 5-part diff if the CD3200 cannot reliably discriminate between cell clusters.
Of course the CD 3200 performs retic counts.
Target: Lab Manager, Technologists / This is an interesting statement that has also recently surfaced. There have been several cases where the Abbott sales reps puts the burden of proof that the CD3200 doesn't do retics back on the Beckman Coulter sales rep. Review their literature - there is no place that documents that the CD3200 can run retics.
You only need 1 box of controls per month
Target: Lab Manager, COO / Most quotes from Abbott provide for only 1 box of controls per month. The control is packaged 12 x 3 mL. Controls should always be run in the same mode as the patient sample, typically the primary - or the closed vial mode. So if you have a CD3200, you would run the control in the closed vial mode. Abbott states the frequency of controls is 2 levels every 8 hours (see CAP Comparisons). The CD3200 sample loader requires 250 µL of sample and has a 1 mL dead volume. If you work the math, that means each bottle has a maximum of 8 aspirations (3 mL - 1 mL (dead volume) = 2 mL. 2 mL / 250 µL = 8) With 4 bottles of each level that means a maximum of 32 aspirations per level per pack a month. That's only enough to run each level 1x per day, not the two that is required.
The HmX is just another MAXM and if the MAXM is such a reliable instrument, why is it being discontinued.
Target: All / The MAXM is, by far, the most successful 5-part diff analyzer ever developed. Why was it so successful? Reliability, ease of use and quality of results to start. The HmX is a proud derivative of the MAXM, built upon that solid platform and made even better! Abbott is just trying to confuse the market once again with their lies, half truths and their lack of knowledge - the MAXM isn't being discontinued!!!