Serology News and Research

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Lancet World Report examines health risks associated with inaccurate TB tests, WHO's upcoming recommendations

With "scores of commercial serology tests for tuberculosis ... being sold in high-burden countries," the "WHO is due to release a negative policy recommendation - the first of its kind for the organisation" - after several reviews have "indicated poor performance of these tests," Lancet World Report writes in a piece that documents the health risks associated with a growing number of inaccurate TB tests.

10 Jan 2011

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

Prometheus launches Crohn's Prognostic test

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today announced the commercial launch of its proprietary PROMETHEUS® Crohn's Prognostic test. This novel and unique diagnostic represents a significant advance in the Prometheus Inflammatory Bowel Disease (IBD) franchise of diagnostic and prognostic tests, and complements the market-leading PROMETHEUS® IBD Serology 7.

2 Sep 2010

Corgenix, ELITech establish broad strategic alliance

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, and the ELITech Group, a Paris, France-based, privately held group of companies and worldwide manufacturer and distributor of in-vitro diagnostic equipment and reagents, today announced a broad strategic alliance.

19 Jul 2010

DGP/tTG Screen assay may be best initial test for suspected celiac disease: Study

Diagnosis of celiac disease is based on a characteristic enteropathy in an intestinal biopsy and evidence that these changes are gluten-triggered. The appropriate use of simpler and more accurate tools would add reliability to the diagnosis of celiac disease. Thus, the celiac disease-related serology might have a key role in defining new diagnostic standards for celiac disease.

9 Jul 2010

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Researchers reported today that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc., may provide clinical benefits to patients with thrombotic microangiopathy (TMA) resulting from uncontrolled complement activation. TMA, the formation of blood clots in capillaries and small arteries, can lead to life-threatening damage in multiple organs including kidney failure, thrombocytopenia (abnormally low platelet count) and anemia.

15 Jun 2010

FDA grants 510(k) market clearance for EraGen's MultiCode-RTx HSV 1&2 Kit

EraGen Biosciences Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for EraGen's MultiCode®-RTx HSV 1&2 Kit.

20 May 2010

ABBOTT PRISM Chagas test receives FDA approval

Abbott received Biologic License Application (BLA) approval from the United States Food and Drug Administration (FDA) for the ABBOTT PRISM Chagas test. The test is a fully automated blood screening assay that can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite found only in the Americas and most commonly acquired through contact with the blood-sucking triatomine or "kissing bug."

19 May 2010

Health Canada grants Response Biomedical Class 3 Medical Device license for RAMP RSV Assay

Response Biomedical Corporation today announced that it has been granted a Class 3 (near patient/point-of-care) Medical Device license by Health Canada to market its RAMP® Respiratory Syncytial Virus (RSV) Assay in Canada.

18 May 2010

International experts discuss threats posed by ticks and fleas

As experts from around the world met in New York this week they discussed the need for greater understanding of the threat posed by ticks, fleas and sand flies. Leading scientists called on veterinarians and dog-owners around the world to take action to protect dogs and humans from potentially lethal diseases.

16 Apr 2010

Emory University researchers develop experimental clinical test for XMRV

The recently discovered retrovirus, xenotropic murine leukemia virus-related virus (XMRV), has been identified in some prostate cancer patients. In light of conflicting data concerning XMRV, standardized diagnostic testing is important to identify patients in which XMRV is present and to determine whether it plays a role in the incidence of prostate cancer.

6 Apr 2010

T-cell cytolytic activity may be effective in clearing HBV infection

Co-infection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) poses a treatment challenge. In Western Europe and the United States, chronic HBV infection has been found in 6%󈝺% of HIV-positive patients and this co-infection is well known to be associated with increased liver-related morbidity and mortality. However, factors associated with HBV surface antigen (HbsAg) loss in HIV and HBV co-infected patients remain unclear.

31 Mar 2010

New DNA test to detect Lyme disease spirochete infection

Many of the more than 30,000 people a year in the United States with suspected cases of Lyme disease spirochete (bacterial) infection can now take a DNA test developed by a Connecticut scientist/physician and his team that can quickly determine if they test positive for Lyme spirochetes in their blood.

30 Mar 2010

SMARTube technology helps physicians create index to get accurate picture of HIV infection

New data presented at the Center for Disease Control -sponsored 2010 HIV Diagnostics Conference suggests that an assay based on SMARTube™ technology may prove useful in developing a standardized measure for estimating what proportion of those infected with HIV have become recently infected.

29 Mar 2010

PPD, Southern Research Institute collaborate in pandemic and seasonal influenza vaccine research

PPD and Southern Research Institute today announced they have formed a collaborative agreement in pandemic and seasonal influenza vaccine research and development to provide clients a full spectrum of influenza vaccine development services by collaborating on client bids and projects.

18 Mar 2010

New nucleic acid test to screen donated blood for HIV-1 Group M RNA approved

Health Canada has approved a new nucleic acid test from Roche Diagnostics to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay.

From Roche Sequencing and Life Science 24 Oct 2009

Researchers question the necessity of duodenal biopsy for celiac disease diagnosis

Duodenal biopsy remains the gold standard for celiac disease (CD) diagnosis. However, it has several pitfalls and requires an invasive procedure in children. In the past few years, a more prominent role for a definitive diagnosis based solely on serology has been proposed. The predictive value of high levels of anti-tissue transglutaminase (tTG) antibodies has also been reported in retrospective CD cohorts.

24 Oct 2009

Progenika to provide blood group genotyping reference laboratory services to ARUP

Progenika, Inc. today announced that it has entered into an agreement with ARUP Laboratories (ARUP) of Salt Lake City, UT, to provide blood group genotyping reference laboratory services to ARUP to determine patient red blood cell antigen profiles when serology has logistic and functional limitations.

22 Oct 2009

Hepatitis B Foundation calls for consistent monitoring and referral of HBV infected children

An expert panel of nationally recognized pediatric liver specialists convened by the Hepatitis B Foundation is calling for more consistent monitoring and referral of children chronically infected with the hepatitis B virus (HBV). The panel's recommendations for pediatricians and other primary care practitioners stress the need for routine monitoring of children with chronic HBV infections, and timely consultation with a pediatric liver specialist.

6 Oct 2009

Quintiles opens an expanded regional facility

To enhance service offerings throughout Europe, Quintiles Transnational Corp. today announced the opening of an expanded regional facility near Edinburgh, Scotland. The purpose-built facility consolidates three buildings into a single state-of-the-art complex.

28 Sep 2009