XMRV -Blood Supply Screening Test

[Guest guest]

From: Jan van Roijen

Date: Sat Nov 27, 2010 3:15 am

Subject: XMRV -Blood Supply Screening Test

http://www.raygent.com/?p=527

Raygent

_____________________________

Business Development And Intelligence

For Healthcare Markets

Biomarkers and Blood Screening Tests:

GenProbe (GPRO) and Genzyme(GENZ)

November 26th, 2010

Here are some relevant news in areas that we

previously covered:

Biomarkers

Genzyme (GENZ) licensed a lung cancer test under

development to Roche and can target a patient's

response to their Tarceva cancer drug. The goal is a

test for epidermal growth- factor receptor (EGFR)

mutations that would be a companion test to identify

people with non-small lung cancer (NSCLC). The

project is partnered with OSI Pharamaceuiticals who

makes the drug.On November 18 Genzyme

announced the sale of their diagnostic products

business for $265M to Sekesui Chemical Co. 2009

revenues for this business was $167 M. This sale

was part of a restructuring related to the sale of the

parent Company.

Blood Supply Screening Test-XMRV

XMRV is a retrovirus that is linked to chronic fatigue

syndrome and there is concern that millions are

infected.

If XMRV can be transmitted through sexually or

through transfusions there may be a need to protect

the blood supply with a screening test similar to

current test for HIV and hepatitis.

Three companies are working on a test: Abbott Labs

(ABT), GenProbe (GPRO) and Roche Molecular

Diagnostics.

GenProbe is a leader in blood screening with their

Tigris diagnostic system that has 2009 revenues of

$450M of which more than 50% are for blood

screening.

GenProbe is partnered with Novartis (NVS) and is

developing a next generation blood screening system

called Panther.

Next month on Dec 14-15 the FDA Blood Products

Advisory Committee will feature scientific data and

research regarding MLV-related (MLV-murine

leukemia virus) Human Retroviruses such as XMRV.

Recently the National Cancer Institute reported on a

test that discriminates between mouse retroviruses

and XMRV.

Blood Products Advisory Committee >

December 14-15, 2010: Blood Products

Advisory Committee Meeting Draft Agenda:

http://bit.ly/exSujY (see below)

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http://bit.ly/exSujY

U.S. Department of Health & Human Services

FDA U.S. Food and Drug Administration

Advisory Committees

December 14-15, 2010: Blood Products Advisory

Committee Meeting Draft Agenda

BLOOD PRODUCTS ADVISORY COMMITTEE

99th Meeting, December 14-15, 2010

The Hilton Washington DC North/Gaithersburg

620 Parkway

Gaithersburg, MD 20877

Tuesday, December 14, 2010

8:00 a.m. Opening Remarks, Blaine Hollinger, M.D.,

Chair

Statement of Conflicts of Interest, Announcements

8:10 a.m.

Topic I: Risk of Dengue Virus Infection in Blood

Donors

1. Introduction and Background of Dengue Virus

Infection, Deborah , Ph.D., DETTD, OBRR, FDA

(10')

2. Dengue Virus Epidemiology in the U.S. and its

Territories, Kay Tomashek, M.D., CDC (15')

3. Risk Model to Define Rate of Infectious Units

During Dengue Virus Outbreaks: Endemic vs.

Non-Endemic Areas, Lyle , M.D., M.P.H., CDC

(25')

4. Update on Dengue Virus Panel Development,

Rios, Ph.D., DETTD, OBRR, FDA (15')

5. Overview of Data on Blood Donor Testing and

Transfusion Transmission of Dengue Virus,

Busch, M.D., Ph.D., Blood Systems Research

Institute (15')

6. Experience with Dengue Virus Antigen Tests,

Harold Margolis, CDC (15')

7. Recent Experience in Testing Blood Donors in

Puerto Rico and Key West, FL, Stramer, Ph.D.,

American Red Cross (15')

10:00 a.m. Break

10:15 a.m. Open Public Hearing

11:00 a.m.

Open Committee Discussion

Questions for the Committee

12:00 p.m. Lunch

1:00 p.m.

Topic II: MLV-related Human Retroviruses and

Blood Safety

1. Introduction and Background, Indira Hewlett,

Ph.D., DETTD, OBRR, FDA (10')

2. Summary of Current Research on MLV-related

Human Retroviruses and Disease Association,

Stoye, Ph.D., NIMR, UK ( 25')

3. Recent Studies of Epidemiology of MLV-related

Human Retroviruses:

i. U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA

(15')

ii. U.S. Study. Maureen Hanson, Ph.D., Cornell

University (15')

iii. UK Study, Judy Mikovits, Ph.D. Whitmore

Institute (15')

4. Animal Studies: Potential Transfusion

Transmission of MLV-related Human Retroviruses,

Francois Villinger, Emory University (20')

5. Update of Blood XMRV Working Group Activities,

Graham , Ph.D., BSRI (15')

6. Prospective and Retrospective U.S. Donor

Surveillance Studies, Busch, M.D., Ph.D.,

Blood Systems Research Institute (15')

7. Assay Development Efforts on MLV-related

Human Retroviruses, Bagni, Ph.D., National

Cancer Institute (20')

3:30 p.m. Break

3:45 p.m. Open Public Hearing

4:30 p.m.

Open Committee Discussion

Questions for the Committee

5:30 p.m. Adjournment

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Wednesday, December 15, 2010

8:00 a.m.

Opening Remarks, Blaine Hollinger, M.D., Chair

Statement of Conflicts of Interest, Announcements

8:10 a.m.

Committee Updates

- Update from the HHS Advisory Committee Blood

Safety and Availability and Summary of November

4-5, 2010 Meeting, Jerry Holmberg, Ph.D., Executive

Secretary, Advisory Committee on Blood Safety and

Availability (15')

- Summary of December 9-10, 2010 Workshop

" Product Development Program for Interventions in

Patients with Severe Bleeding Due to Trauma or

Other Causes, " Jaro Vostal, M.D., Ph.D., DH, OBRR,

FDA (15')

9:00 a.m. Break

9:15 a.m.

Topic III: Review of the Research Programs in the

Laboratories of Hemostasis and Plasma

Derivatives, Division of Hematology, OBRR

1. Overview of CBER Research, Carolyn ,

Ph.D., CBER, FDA (15')

2. Overview of OBRR Research, C.D. Atreya, Ph.D.,

OBRR, FDA (15')

3. Overview of the Division of Hematology

Research Program, Basil Golding, M.D., DH, OBRR,

FDA (15')

4. Overview of the Laboratory of Hemostasis,

Lee, Ph.D., DH, OBRR, FDA (30')

Questions & Answers (15')

5. Overview of the Laboratory of Plasma

Derivatives, Dorothy , M.D., DH, OBRR (30')

Questions and Answers (15')

11:30 a.m. Open Public Hearing

12:00 p.m. Closed Committee Discussion

12:45 p.m. Adjournment