Off Label Communications in Press Release













If this test did what RK PHD claims it does shouldn't this be a slam dunk success by now--seven years right? Why hasn't some savvy business bought this product? Maybe new sales people will make the difference, to steal a phrase from when the same era this was conceived.

That's the ticket.

but rich also knows the test is measuring other stuff and that is the core of the issue since results are confounded
 


















ImmuKnow is a biomarker of immune function that complements immunomodulatory therapy and helps physicians and other healthcare professionals more effectively manage immunosuppression in posttransplant patients, thereby reducing the risks of infection and rejection by:

Providing a global marker of immune function and response to immunosuppression at the cellular level Detecting changes in CD4 cell ATP production Helping to define a range of stable immune function for each patient Providing critical, actionable information on an ongoing, individual basis when used longitudinally (in combination with other routine monitoring tests)

ImmuKnow is the FDA-cleared assay that tracks changes in global immune function over time.

Hmm that is not what the intended use statement says. So mr compliance officer what say you? or mr govt?
 






Hmm that is not what the intended use statement says. So mr compliance officer what say you? or mr govt?

How many more centers are going to stop using? Might as well move operations to Europe or sell teh company to Sigma Tau. Mr Stewart should have an in there. Where is doug Brown and does anyone care?
 






How many more centers are going to stop using? Might as well move operations to Europe or sell teh company to Sigma Tau. Mr Stewart should have an in there. Where is doug Brown and does anyone care?

hey is the guy from Abbott still there as the sales vp? How come his name is not on the leadership list on the web? don't tell me another one is gone. did you hear that Carol sued the company for falsely exaggerating sales a couple of years ago? What did that cost us.
 






look please get off our board. it is very simple really. you have a product that is measuring something else besides what the IFU says. you have an organization led by an egomaniac that doesn't have a clue or want s to know about transplantation. you have a sales force that was decimated by the CFO that isnt here anymore and a sales guy that is two managers ago. big centers have jumped ship so selling effort is focusing on international markets. so the only way to communicate what you cant say is through press releases and the web. the ceo is a hypocrite and now knows what needs to be said to even have a chance of people using the product.
 






look please get off our board. it is very simple really. you have a product that is measuring something else besides what the IFU says. you have an organization led by an egomaniac that doesn't have a clue or want s to know about transplantation. you have a sales force that was decimated by the CFO that isnt here anymore and a sales guy that is two managers ago. big centers have jumped ship so selling effort is focusing on international markets. so the only way to communicate what you cant say is through press releases and the web. the ceo is a hypocrite and now knows what needs to be said to even have a chance of people using the product.

All you need to know is to look at the sales team that was - EN; CB; CD; AP; PM; RF; KE; JP; that was a pretty good group that was left alone to sell - wonder why they all left? DB and BS
 












All you need to know is to look at the sales team that was - EN; CB; CD; AP; PM; RF; KE; JP; that was a pretty good group that was left alone to sell - wonder why they all left? DB and BS

You're right, that was a good group. The biggest mistake the company made was letting go of Petruny. Good guy who knew the TX market.
Are they still stuck in the $7m sales figures? The original investors in this company about 8-10 years ago have got to be chalking this up as a loss. Unless of course, some company with too much money laying around decides to buy it and we can all cash in our worthless options! Please!
 






You're right, that was a good group. The biggest mistake the company made was letting go of Petruny. Good guy who knew the TX market.
Are they still stuck in the $7m sales figures? The original investors in this company about 8-10 years ago have got to be chalking this up as a loss. Unless of course, some company with too much money laying around decides to buy it and we can all cash in our worthless options! Please!


OK-CafePharma, for entertainment purposes only, play at your own risk. The big year was 2008. Change in CEO, new president, key people left on their own, then some key people were asked to leave. Then more people left who liked the people who were asked to leave. This is not about sales and marketing, if the test did what it said it would do it should be off the charts by now. It has been in major transplant centers, biggest most influential in the world. It is not languishing because it didn't get a shot, or it needs a better VP of Sales and Marketing. Very few remain from that year. The few that do, know the real reason why this has not gone the way we all hoped in 2008.
 












Thanks for illuminating us with your response.


Are you sure about all of these? A number have dropped the test. Patient advertising - interesting concept!


University of Arkansas for Medical Sciences

4301 West Markham Street

Little Rock

AR

72205

501.686.7000

www.uams.edu



Loma Linda University Medical Center

11234 Anderson Street

Loma Linda

CA

92354

877.558.6248

www.lomalindahealth.org



METIC Immunogenetics Consultants, Inc.

1640 Marengo Street

Los Angeles

CA

90033

323.221.2177

N/A



Quest Diagnostics

33608 Ortega Highway

San Juan Capistrano

CA

92675

800.642.4657

www.questdiagnostics.com



Ronald Reagan UCLA Medical Center

757 Westwood Plaza

Los Angeles

CA

90095

310.825.9111

www.uclahealth.org



Stanford University School of Medicine

300 Pasteur Drive

Stanford

CA

94305

650.723.4000

www.med.stanford.edu



UC Davis Transplant Center

2315 Stockton Boulevard

Sacramento

CA

95817

800.821.9912

www.ucdavis.edu



UC San Diego Health System

200 West Arbor Drive

San Diego

CA

92103

619.543.5710

www.health.ucsd.edu



UCSF Medical Center at Parnassus

505 Parnassus Avenue

San Francisco

CA

94122

415.476.1000

www.ucsfhealth.org



Cedars-Sinai Medical Center

8700 Beverly Boulevard

Los Angeles

CA

90048

310.423.3277

www.csmc.edu



University of Colorado Hospital - Anschutz Medical Campus

1635 Aurora Court

Aurora

CO

80045

720.848.0000

www.uch.edu



A.I. duPont Hospital for Children

1600 Rockland Road

Wilmington

DE

19803

302.651.4000

www.nemours.org



Florida Hospital

601 East Rollins Street

Orlando

FL

32703

407.303.2800

www.floridahospital.com



LifeLink Foundation

409 Bayshore Boulevard

Tampa

FL

33606

800.262.5775

www.lifelinkfound.org



Shands at the University of Florida

1600 SW Archer Road

Gainesville

FL

32610

352.265.8000

www.shands.org



University of Miami - Miller School of Medicine

1600 NW 10th Avenue, RSMB 8th Floor

Miami

FL

33136

305.243.3131

www.labs.med.miami.edu



Piedmont Hospital

1968 Peachtree Road NW

Atlanta

GA

30309

404.605.5000

www.piedmonthospital.org



Memorial Medical Center

701 North First Street

Springfield

IL

62781

217.788.3000

www.memorialmedical.org



Quest Diagnostics

1355 Mittel Boulevard

Wood Dale

IL

60191

800.323.5917

www.questdiagnostics.com



The University of Chicago Medical Center

5841 South Maryland Avenue

Chicago

IL

60637

773.702.1000

www.uchospitals.edu



Methodist Hospital

1801 North Senate Boulevard

Indianapolis

IN

46202

317.962.2000

www.clarian.org



Jewish Hospital Louisville

200 Abraham Flexner Way

Louisville

KY

40202

502.587.4011

www.jhsmh.org



University of Kentucky Healthcare Transplant Center

800 Rose Street

Lexington

KY

40536

859.257.1000

www.ukhealthcare.uky.edu



The Blood Center

315 South Johnson Street

New Orleans

LA

70112

504.593.1921

www.thebloodcenter.org



Tufts Medical Center

800 Washington Street

Boston

MA

02111

617.636.5000

www.tuftsmedicalcenter.org



Detroit Medical Center/Harper University Hospital

3990 John R. Street

Detroit

MI

48201

313.745.6000

www.harperhospital.org



Quest Diagnostics

4444 Giddings Road

Auburn Hills

MI

48326

248.373.9120

www.questdiagnostics.com



University of Minnesota Medical Center - Fairview (University Campus)

500 Harvard Street

Minneapolis

MN

55455

612.273.3000

www.uofmmedicalcenter.org



Barnes Jewish Hospital

1 Barnes-Jewish Hospital Plaza

St. Louis

MO

63110

314.747.3000

www.barnesjewish.org



ViraCor/IBT Laboratories

1001 NW Technology Drive

Lee's Summit

MO

64086

800.305.5198

www.viracoribt.com



Duke University Medical Center

2301 Erwin Road

Durham

NC

27710

888.275.3853

www.dukehealth.org



East Carolina University

600 Moye Boulevard

Greenville

NC

27834

252.744.1020

www.ecu.edu



UNC Healthcare - North Carolina Memorial Hospital

101 Manning Drive

Chapel Hill

NC

27514

919.966.4131

www.unchealthcare.org



TriCore Reference Laboratories

1001 Woodward Place NE

Albuquerque

NM

87102

800.245.3296

www.tricore.org



Columbia University Medical Center

630 West 168th Street

New York

NY

10032

212.305.2862

www.cumc.columbia.edu



IMMCO Diagnostics, Inc.

60 Pineview Drive

Buffalo

NY

14228

800.537.8378

www.immcodiagnostics.com



Westchester Medical Center

100 Woods Road

Valhalla

NY

10595

914.493.7000

www.worldclassmedicine.com



CompuNet Clinical Laboratories

2308 Sandridge Drive

Moraine

OH

45439

800.686.2252

www.compunetlab.com



University Hospitals Case Medical Center

11100 Euclid Avenue

Cleveland

OH

44106

888.844.8447

www.uhhospitals.org



Cleveland Clinic

9500 Euclid Avenue

Cleveland

OH

44195

800.223.2273

www.clevelandclinic.org



Diagnostic Laboratory of Oklahoma

1001 Cornell Parkway

Oklahoma City

OK

73108

405.609.2000

www.dlolab.com



Albert Einstein Medical Center

5501 Old York Road

Philadelphia

PA

19141

215.456.7890

www.einstein.edu



Geisinger Health System

100 North Academy Avenue

Danville

PA

17822

800.275.6401

www.geisinger.org



Allegheny General Hospital

320 East North Avenue

Pittsburgh

PA

15212

412.359.3131

www.alleghenymedical.com



Milton S. Hershey Medical Center

500 University Drive

Hershey

PA

17033

717.531.8521

www.pennstatehershey.org



Quest Diagnostics

900 Business Center Drive

Horsham

PA

19044

800.825.7320

www.questdiagnostics.com



University of Pittsburgh Medical Center

200 Lothrop Street

Pittsburgh

PA

15213

800.533.8762

www.upmc.com



Central PA Transplant Associates

205 South Front Street

Harrisburg

PA

17104

717.231.8804

www.pinnaclehealth.org



Childrens Hospital of Philadelphia

34th Street & Civic Center Boulevard

Philadelphia

PA

19104

215.590.1000

www.chop.edu



Methodist University Hospital Transplant Institute

1265 Union Avenue

Memphis

TN

38104

866.805.7710

www.methodisthealth.org



Quest Diagnostics

5850 Rogerdale

Houston

TX

77072

800.669.6605

www.questdiagnostics.com



Southwest Immunodiagnostics

8122 Datapoint Drive

San Antonio

TX

78229

800.903.1642

N/A



Texas Tech University

2500 Broadway

Lubbock

TX

79409

806.742.2011

www.ttu.edu



The Methodist Hospital

6565 Fannin Street

Houston

TX

77030

713.790.3311

www.methodisthealth.com



The Texas Transplant Institute

8201 Ewing Halsell Drive, Second Floor (kidney, pancreas, liver)

Methodist Plaza
4499 Medical Drive, Suite 166 (heart)

San Antonio

TX

78229

800.888.0402
(kidney, pancreas, liver)

877.791.5438
(heart)

www.texastransplant.org



The University of Texas Health Science Center at Houston

7000 Fannin, #1200

Houston

TX

77030

713.500.4472

www.uthouston.edu



Baylor University

1102 Bates Street

Houston

TX

77030

713.798.4951

www.baylorhealth.com



University Hospital Services (UHS)

4502 Medical Drive

San Antonio

TX

78229

210.358.4000

www.uhs.com



UT Southwestern Medical Center

5323 Harry Hines Boulevard

Dallas

TX

75390

214.648.3111

www.utsouthwestern.edu



ARUP Laboratories

500 Chipeta Way

Salt Lake City

UT

84108

800.242.2787

www.arup-lab.com



Quest Diagnostics

14225 Newbrook Drive

Chantilly

VA

20151

800.336.3718

www.questdiagnostics.com



Quest Diagnostics (New York State samples)

14225 Newbrook Drive

Chantilly

VA

20151

800.336.3718

www.questdiagnostics.com



The Sentara Transplant Center (Sentara Norfolk General Hospital)

600 Gresham Drive

Norfolk

VA

23507

757.388.3000

www.sentara.com



Puget Sound Blood Center

921 Terry Avenue

Seattle

WA

98057

206.292.6500

www.psbc.org



University of Washington Medical Center

1959 NE Pacific Street

Seattle

WA

98195

206.598.3300

uwmedicine.washington.edu
 






ImmuKnow is a biomarker of immune function that complements immunomodulatory therapy and helps physicians and other healthcare professionals more effectively manage immunosuppression in posttransplant patients, thereby reducing the risks of infection and rejection by:

Providing a global marker of immune function and response to immunosuppression at the cellular level Detecting changes in CD4 cell ATP production Helping to define a range of stable immune function for each patient Providing critical, actionable information on an ongoing, individual basis when used longitudinally (in combination with other routine monitoring tests)

ImmuKnow is the FDA-cleared assay that tracks changes in global immune function over time.

Not only is the above not in the IFU, but now the company is promoting reimbursement rates for the test. Can you do this? Does FDA know about this?