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The partners aim to refine a saliva-based SARS-CoV-2 test developed by Yale that received Emergency Use Authorization from the FDA earlier this year.
The randomized, Phase II trial will test ctDNA-guided second-line adjuvant therapy for stage II and III hormone receptor-positive, HER-2 negative breast cancer.
In clinical samples, the researchers detected more viral copies in saliva than in NP swabs, and more saliva samples remained positive for up to 10 days.
The test could be used in most high-complexity labs because it has been authorized for use with different combinations of frequently used reagents and instruments.
Regular SARS-CoV-2 testing could limit COVID-19 cases on university campuses but results might vary based on the schools' behavioral interventions.
A number of diagnostic labs have considered saliva-based SARS-CoV-2 testing but decided against it, while other groups continue to pursue it.
Yale researchers said that they anticipate their RNA extraction-free saliva assay will make testing more scalable, affordable, and available to the public.
Replacing nasopharyngeal swabs with saliva samples or nasal swabs could increase throughput and convenience, as well as relieve reagent and equipment shortages.
Veracyte has obtained rights to a 52-gene signature developed by Yale researchers to predict disease progression in patients with idiopathic pulmonary fibrosis.
Under the EUA, the lab is authorized to detect SARS-CoV-2 in specimens collected from individuals suspected of having COVID-19 by their healthcare provider.