Blog de jsd4026

France Biotech, the French organization biotech companies is asking the French government for help. With the global economic crisis, total investments in biotech companies dropped 79% in 2008, a drop from 694M EUR ($890M) in 2007 to 143M EUR ($184M) in 2008.

Wow, that's a lot.

And get this, investments into public companies only totaled 12M EUR ($15M) in 2008, down 98% from 2007!! Yikes!

VC's only pumped in 132M EUR ($170M) in 2008, a decrease of 27% compared to 07.

France Biotech's Chairman, Philippe Pouletty, said this:

“In order to underpin the optimism of our entrepreneurs, we must adopt an aggressive stimulus plan for young, innovative companies. Assuming that they can access finance, today's innovative SMBs will become tomorrow's multinationals and thus constitute an essential driver of strong, sustainable economic growth.”

The organization went on to say that 09 will be more of the same and that they would like to double to budget allocation French state innovation agency OSEO, including tax reforms and revisions of research tax credits

These are hard times indeed. We need more cash to fuel the blockbusters and acquisition targets of tomorrow...

Read about it at Marketwatch:
http://www.marketwatch.com/news/story/france-biotech-reports-79-fall/story.aspx?guid={3CF2D8BA-D14E-478F-8EBE-51AA4A4658A6}&dist=msr_1

Recruitment of Donors with Tick Borne diseases is challenging. This is mostly due to inconsistencies within the disease testing and diagnosis process – there are an abundance of both false positives and false negatives. Additionally, getting donors with the diseases to contact SeraCare is challenging since there is wide spread apprehension among those diagnosed with these diseases due to the problems they experience trying to get diagnosed and treated. This is especially true for Lyme Disease.

The Trick: For Lyme, RMSF, and Babesia, find donors that need money. For adults, Lyme and Babesia are primarily in New England while RMSF is primarily in the Western U.S. HGE and Tularemia are lesser known and have not been needed by SeraCare so the focus of recruitment will be on RMSF, Lyme, and Babesia. Once a donor has been identified, empathize with them – they are probably in pain and tired of dealing with the testing issues. Confirm 'Clinical' Diagnosis by getting a copy of the patient file. Service their needs – arrange travel, fill out forms for them over the phone, send driving directions, etcetera. Prequalify them by using a variety of available test methods – for Lyme, use one EIA from each of the three groups (Lyme, LymeM, and LymeC).

OTHER CONSIDERATIONS
• Rash occurs 75-90% of the time with Lyme disease, 5-10% with HGE.
• Elevated liver function tests (LFT's): May be tularemia, Lyme disease, RMSF, or HGE, further tests needed.
• Bell's palsy presentation may be Lyme disease, further tests needed.
• Regional adenopathy? Look for a small ulceration distally. May be ulceroglandular tularemia, further tests needed.
• Coinfections with Lyme disease, babesiosis, and HGE may occur. The deer tick transmits all three diseases. Although RMSF has not been identified in the Deer Tick, results from SeraCare's analysis of several donor samples found donors in Pennsylvania and Montana that had positive tests for both Lyme and RMSF in their IGM state. While cross-reactivity is possible, only half of cases showed positive test results to both.
• RMSF is relatively rare and is transmitted via a dog tick bite or, rarely, when an infected dog tick is crushed or accidentally inoculated onto mucous membrane surfaces such as the conjunctiva.
• Tularemia is relatively rare and its clinical presentation will depend on how the bacteria are transmitted. Ulceroglandular or glandular tularemia is generally the result of a dog tick bite or direct contact with an infected animal. The bacteria can also be transmitted through the conjunctiva from contaminated fingers, splashes or aerosols (oculoglandular), via ingestion of water or meat that has been contaminated by an infected animal (pharyngeal), or by inhalation of contaminated particles (pneumonic).
• Physicians should consider pneumonic tularemia in any patient presenting with community-acquired pneumonia who resides on or has recently visited Martha's Vineyard.

FINDINGS FROM ROUTINE DIAGNOSTIC LABORATORY TESTS
• Elevated sedimentation rate (generally with localized or early disseminated disease)
• Mildly elevated hepatic transaminases (generally with localized or early disseminated disease)
• For cases of Lyme meningitis, CSF typically has a lymphocytic pleocytosis with slightly elevated protein levels and normal glucose levels

DIAGNOSTIC LABORATORY CRITERIA
• Demonstration of diagnostic IgM or IgG antibodies to B. burgdorferi in serum or cerebrospinal fluid. A two-tier testing protocol is recommended. A sensitive enzyme immunoassay (EIA) or immunofluorescence antibody (IFA) is completed first followed by a Western blot if the EIA or IFA is positive or equivocal, or
• Isolation of B. burgdorferi from a clinical specimen.
Note: Consider testing for babesiosis and HGE.

Note: Serologic tests should only be used to support a CLINICAL DIAGNOSIS of Lyme disease.
Serologic testing is not recommended for patients diagnosed with Lyme disease because of an EM rash. Also, keep in mind when interpreting serologic test results:
Tests are not 100% sensitive or specific and are particularly insensitive in early Lyme disease.
Tests cannot distinguish between active and past infection.
A false negative test may occur if done too early for a patient to mount an immune response or if a patient received antibiotics prior to testing.
A false positive test may occur if a patient is producing antibodies which cross react on the test, either for unknown reasons, or in response to a disease such as rheumatoid arthritis, infectious mononucleosis, systemic lupus erythematosus, spirochetal periodontal infections, relapsing fever, leptospirosis, Rocky Mountain spotted fever, or syphilis.

FINDINGS FROM LABORATORY TESTS
• Donors that were identified as having Lyme Disease by the Diagnostic Criteria given by the CDC did not always test positive on EIA tests.
• The three groups of EIA's used (Lyme, LymeM, and LymeC) do not report results consistent with each other. Any one or two may report positive results while the other/s may report negative results. There were instances of only one of the three groups of EIA's being positive with the other two being negative. The most peculiar of these examples was when LymeC was negative when LymeM was positive.
• No single EIA test consistently reported Lyme Positive results for donors that were found to be Lyme Positive through other EIA tests. Every EIA used reported negative results at least once while every other test used reported positive results.
• Lyme EIA results generally report the same qualitative result as other EIA's in the same group (Lyme, LymeM, or LymeC).

LABORATORY CRITERIA
• SeraCare should test each qualifying donor sample and unit with a combination of Lyme EIA's to reduce the odds of false positives and false negatives. Due to the consistency of test results between EIA's in the same group for donors with a positive WB, and the inconsistency between EIA groups (Lyme, LymeM, and LymeC), it is recommended that one EIA from each of the three groups be used to test each sample.

Note: Donor Collection and Research Laboratory tests should only be used to support a CLINICAL DIAGNOSIS of Lyme disease.
Serologic testing is not recommended for patients diagnosed with Lyme disease because of an EM rash. Also, keep in mind when interpreting serologic test results:
Tests are not 100% sensitive or specific and are particularly insensitive in early Lyme disease.
Tests cannot distinguish between active and past infection.
A false negative test may occur if done too early for a patient to mount an immune response or if a patient received antibiotics prior to testing.
A false positive test may occur if a patient is producing antibodies which cross react on the test, either for unknown reasons, or in response to a disease such as rheumatoid arthritis, infectious mononucleosis, systemic lupus erythematosus, spirochetal periodontal infections, relapsing fever, leptospirosis, Rocky Mountain spotted fever, or syphilis.

FINDINGS LABORATORY TESTS ON SELLABLE DONOR MATERIAL
EBV CA IgG does not produce a false positive Lyme (Wampole) or Lyme WB
EBV NA IgG does not produce a false positive Lyme (Wampole) or Lyme WB
CMV IgG does not produce a false positive Lyme (Wampole) or Lyme WB
Babesia IgM does not produce a false positive Lyme (Wampole)
RMSF does not produce a false positive Lyme (Wampole)
Babesia may produce a 23M Lyme band
Lyme; 23G, 23M, and 41M were always positive, even after 2 years, on donors that also have positive EIA's.
Some patients show no IgG seroconversion, IgM may continue years after
RMSF patients have a >50% chance of also having a positive Lyme WB and EIA.
Samples that test positive for Lyme WB usually do not test positive on Lyme EIA.