FDA finalizing plan for regulatory approval of DTC genetic testing | Study: Genetic susceptibility to dengue varies with ethnicity | Continued gene activity following death could be helpful in forensics
February 20, 2018
AACC SmartBrief
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FDA finalizing plan for regulatory approval of DTC genetic testing
While Senate Minority Leader Chuck Schumer, D-N.Y., has called for an investigation of direct-to-consumer genetic testing companies' privacy policies, the FDA is working on hastening the regulatory approval of DTC genetic testing in order to help expand the testing market. "The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation, as these technologies don't fit squarely into our traditional risk-based approach to device regulation," according to a statement released by FDA Commissioner Scott Gottlieb.
Clinical Laboratory News (1/2018) 
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Science Briefs
Study: Genetic susceptibility to dengue varies with ethnicity
Researchers from the Institut Pasteur-Paris found that gene variations that influence susceptibility to dengue fever and dengue shock syndrome differ among world populations, according to a study in the journal PLOS Neglected Tropical Diseases. "The particular genetic risk conferred by these genes indicates that Southeast and Northeast Asians are highly susceptible to both phenotypes, while Africans are best protected against DSS and Europeans best protected against DF, but the most susceptible to DSS," the study team wrote.
GenomeWeb Daily News (free registration) (2/15) 
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Continued gene activity following death could be helpful in forensics
Some genes remain functional and even become more active following an individual's death, and researchers think this could be helpful for forensic science, according to findings published in Nature Communications. "We conclude there is a signature or a fingerprint in the pattern of gene expression after death that could eventually be used in forensic science, but we don't pretend we have now a method that can be used in the field," said study author Roderic Guigo.
BBC (2/13) 
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Study: Diabetes ups mortality risk in takotsubo syndrome
A study in Diabetes Care showed that patients with takotsubo syndrome and diabetes had a higher mortality rate and a higher prevalence of hypertension and physical triggers than those without diabetes. German researchers used a cohort of 826 adults with takotsubo syndrome with and without diabetes, mean age of 72, and found that those with diabetes had more severely impaired left ventricular ejection fraction due to typical apical ballooning, a longer hospital stay and a higher pulmonary edema rate, compared with patients without diabetes.
Healio (free registration)/Endocrine Today (2/16) 
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Tech Briefs
Guardant's liquid biopsy test wins expedited access status from FDA
Guardant Health secured Expedited Access Pathway designation from the FDA for its comprehensive next-generation sequencing-based liquid biopsy test for advanced cancer called Guardant360. Using next-generation sequencing, the assay allows genomic alterations in a panel of 73 genes to be detected from cell-free DNA withdrawn from blood.
BioCentury (2/16) 
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Policy Briefs
USPSTF recommends against ovarian cancer screening in asymptomatic women
The US Preventive Services Task Force released new guidelines in the Journal of the American Medical Association advising against ovarian cancer screening for women with no signs or symptoms of the disease, as the harms of screening outweigh the benefits, but the recommendation does not apply to women who are at high risk of ovarian cancer, including those who carry a BRCA gene mutation. "Evidence shows that current screening methods do not prevent women from dying of ovarian cancer and that screening can lead to unnecessary surgery in women without cancer," task force member Michael Barry said.
HealthDay News (2/13),  MedPage Today (free registration) (2/13) 
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Practice Briefs
Quidel's influenza test wins FDA clearance, meets Class II RIDT criteria
Quidel's QuickVue Influenza A+B assay was granted 510(k) clearance by the FDA and has met the agency's reclassification criteria for Class II rapid influenza diagnostic tests. The assay, formerly CLIA waived, enables direct qualitative detection of influenza A and B antigens from nasopharyngeal or nasal swabs of symptomatic patients.
360Dx (tiered subscription model) (2/14) 
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Banyan Biomarkers' concussion assay gains FDA approval
Banyan Biomarkers' Brain Trauma Indicator is the first blood test to receive FDA approval to screen for a certain type of brain damage that is usually only detectable with CT scans. The test assesses levels of two proteins, UCH-L1 and GFAP, and it could reduce the need for unnecessary neuroimaging tests and radiation exposure.
STAT (tiered subscription model) (2/14) 
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Business/Corporate Briefs
Thermo Fisher's PCR tech to be used in OpGen's gene panel tests
An agreement was reached by OpGen with Thermo Fisher Scientific to allow Thermo Fisher's real-time PCR technology to be used in its line of Acuitas AMR Gene Panel tests. Under the deal, for which terms were undisclosed, OpGen's u5.47 test for multiplex gene detection will incorporate Thermo Fisher's TaqMan Fast Advanced Master Mix and TaqMan probes.
GenomeWeb Daily News (free registration) (2/13) 
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$3.56M private placement, strategic alliance pursued by Genetic Technologies
Genetic Technologies, a molecular diagnostics company in Australia, announced plans to launch a private placement of up to 324.7 million newly issued shares in hopes of obtaining up to approximately $3.56 million. The company added that is in talks with Blockchain Global to create a strategic alliance on the development of medical and biotechnology applications integrating their technologies.
GenomeWeb Daily News (free registration) (2/15) 
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