Lab News
FDA's green light for InBios product signals arrival of Zika virus tests
May 24, 2019 -- The U.S. Food and Drug Administration (FDA) cleared InBios International's blood test on May 23 for detecting immunoglobulin antibodies to Zika virus -- in a first for the U.S. market -- and is considering revoking clearance for companies that have emergency use authorizations for similar tests.
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May 24, 2019 -- The U.S. Food and Drug Administration (FDA) cleared InBios International's blood test on May 23 for detecting immunoglobulin antibodies to Zika virus -- in a first for the U.S. market -- and is considering revoking clearance for companies that have emergency use authorizations for similar tests.
Discuss FDA announces Beckman Coulter recall of hematology analyzers
May 23, 2019 -- Beckman Coulter Life Sciences has recalled several of its hematology analyzers due to the risk of inaccurate results, according to a U.S. Food and Drug Administration (FDA) notification from May 23. Some 2,000 clinical labs in the U.S. may be affected by the recall.
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May 23, 2019 -- Beckman Coulter Life Sciences has recalled several of its hematology analyzers due to the risk of inaccurate results, according to a U.S. Food and Drug Administration (FDA) notification from May 23. Some 2,000 clinical labs in the U.S. may be affected by the recall.
Discuss Classic lab tests dominate in international survey
May 23, 2019 -- Sometimes the classics can't be beat. A new survey of the top lab tests performed around the world found that classic diagnostic tests dominate, despite differences in per capita income in different countries, according to a study published May 22 in the American Journal of Clinical Pathology.
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May 23, 2019 -- Sometimes the classics can't be beat. A new survey of the top lab tests performed around the world found that classic diagnostic tests dominate, despite differences in per capita income in different countries, according to a study published May 22 in the American Journal of Clinical Pathology.
Discuss Study homes in on genetic risk for type 2 diabetes
May 22, 2019 -- An exome sequencing study of almost 46,000 people has pinpointed four genes with rare variants that put people at risk for type 2 diabetes, a large team of international researchers led by the Broad Institute of MIT and Harvard reported in the journal Nature on May 22.
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May 22, 2019 -- An exome sequencing study of almost 46,000 people has pinpointed four genes with rare variants that put people at risk for type 2 diabetes, a large team of international researchers led by the Broad Institute of MIT and Harvard reported in the journal Nature on May 22.
Discuss Growth in number, complexity of CLIA-waived test kits raise red flags
May 22, 2019 -- Providers of proficiency testing for CLIA tests are becoming increasingly concerned about the lack of external quality control and oversight of CLIA-waived test kits, as the number of waived kits continues to expand. Some 1,400 waived test kits are now on the market, compared with 30 three decades ago.
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May 22, 2019 -- Providers of proficiency testing for CLIA tests are becoming increasingly concerned about the lack of external quality control and oversight of CLIA-waived test kits, as the number of waived kits continues to expand. Some 1,400 waived test kits are now on the market, compared with 30 three decades ago.
Discuss Should blood donations be screened for high cholesterol?
May 22, 2019 -- Should individuals who donate blood have their donations screened for signs of high cholesterol? The authors of a study published in JAMA Cardiology on May 22 suggest that such screening could identify many people -- particularly younger individuals -- who might have familial hypercholesterolemia but might not otherwise know it.
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May 22, 2019 -- Should individuals who donate blood have their donations screened for signs of high cholesterol? The authors of a study published in JAMA Cardiology on May 22 suggest that such screening could identify many people -- particularly younger individuals -- who might have familial hypercholesterolemia but might not otherwise know it.
Discuss Tumor mutational burden biomarker may not pass muster (again) at ASCO
May 20, 2019 -- Foundation Medicine is set to present data supporting its cancer diagnostics and the tumor mutational burden biomarker at the American Society of Clinical Oncology (ASCO) meeting, set for May 31 to June 4.
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May 20, 2019 -- Foundation Medicine is set to present data supporting its cancer diagnostics and the tumor mutational burden biomarker at the American Society of Clinical Oncology (ASCO) meeting, set for May 31 to June 4.
Discuss Single-cell sequencing supplies clues about managing lupus
May 20, 2019 -- Single-cell RNA sequencing (scRNA-seq) helped researchers identify a molecular signature associated with response to treatment for lupus nephritis in a study of renal and skin biopsies published May 20 in Nature Immunology.
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May 20, 2019 -- Single-cell RNA sequencing (scRNA-seq) helped researchers identify a molecular signature associated with response to treatment for lupus nephritis in a study of renal and skin biopsies published May 20 in Nature Immunology.
Discuss So far, so good with NCI pediatric molecular screening study
May 16, 2019 -- In a large molecular screening study sponsored by the U.S. National Cancer Institute (NCI), 24% of pediatric cancer patients were matched with targeted therapies based on genetic profiles from tumor samples, a better than expected result, investigators reported during an American Society of Clinical Oncology press briefing on May 15.
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May 16, 2019 -- In a large molecular screening study sponsored by the U.S. National Cancer Institute (NCI), 24% of pediatric cancer patients were matched with targeted therapies based on genetic profiles from tumor samples, a better than expected result, investigators reported during an American Society of Clinical Oncology press briefing on May 15.
Discuss Liquid biopsies show the way in melanoma and rectal cancer
May 16, 2019 -- The potential role for circulating tumor DNA in guiding treatment and monitoring response received more support from a pair of separate studies on rectal cancer and melanoma published May 15 in association with medical meetings.
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May 16, 2019 -- The potential role for circulating tumor DNA in guiding treatment and monitoring response received more support from a pair of separate studies on rectal cancer and melanoma published May 15 in association with medical meetings.
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News in Brief
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