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Under the LCD, oncology biomarkers must have proven clinical validity and there must be acceptance of specific testing into patient management.
Spectrum Solutions' specimen collection device is used with SARS-CoV-2 saliva tests from DxTerity Diagnostics and RUCDR Infinite Biologics.
The researchers also developed a web-based tool based on the data they gathered that could help predict COVID-19 severity in patients.
News items for the week of Oct. 5, 2020.
Oxford Nanopore said it is rolling out the LamPore test globally, initially in the UK, Germany, Switzerland, and the United Arab Emirates.
The company said that the FDA has granted it Emergency Use Authorization for a respiratory panel that includes SARS-CoV-2, flu, and other pathogens.
An Invitae-led retrospective study found almost a third of cancer patients who underwent germline genetic testing after tumor sequencing had pathogenic variants.
The general LCD is covered for patients with a personal history of melanoma undergoing workups or being evaluated for treatment without metastatic disease.
The partners aim to identify markers of patient immune response to the virus that could be used to inform development of therapies and vaccines for the disease.
The genome-wide association study, conducted by a DeCode Genetics-led team, further uncovered variants influencing the perception of licorice and cinnamon smells.
Under a licensing deal, Omixon will sell the AzureSeq-200 RT-PCR kit under its brand in Europe, the Middle East, and Africa.
The Seattle-based genomics technology firm said it intends to use the funds for working capital and general corporate purposes.
Several Treponema sublineages cropped up after a large antibiotic campaign, though sequence data suggests resistance may have arisen only once.
Investigators are conducting a prospectively designed, retrospective study of archived material from the NeoTRIPaPDL1 triple negative breast cancer trial.
Natera said that the expanded coverage by Centene will add 24 million people for whom the Panorama noninvasive prenatal test will be covered.
The company's Advanta Dx SARS-CoV-2 RT-PCR assay received Emergency Use Authorization from the US Food and Drug Administration in August.
Seasun Biomaterials' test is designed to detect SARS-CoV-2 RNA, while Zeus Scientific's test detects IgG antibodies against the virus.
The company said it provided approximately 21,800 total AlloSure and AlloMap patient results during the quarter.
The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.
The NGS-based test is intended for use by lab personnel trained to use Illumina's MiSeq and NextSeq systems.
The effort, which will be the flagship project of the Children's Mercy Research Institute, aims to collect genomic data from 30,000 children and their families.
The literature shows high specificity and sensitivity for cfDNA testing in twin pregnancies. It could also be a viable screening option for triplet pregnancies.
The partners plan to build a database of genomic and patient-reported data to identify how genetics can impact disease outcome.
The UK and the European Union have come to a sticking point in the negotiation of how the UK might remain involved in the Horizon Europe research program, the Guardian reports.
The New York Times reports that experts pushed during a meeting of an FDA advisory board for the agency to require more safety data from SARS-CoV-2 vaccine trials.
The Washington Post reports Moderna expects that it will have enough data on its candidate SARS-CoV-2 vaccine to submit to regulatory authorities by mid-November.
In Science this week: ANXA11 variants affect calcium homeostasis and stress granule disassembly in ALS, and more.