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Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing rapidly expanding cancer test offerings.
The UK government said that it plans this year to repeal regulations specific to COVID-19 tests as part of the alignment with EU Common Specifications.
The companies have partnered with the goal of streamlining point-of-care access to Guardant's genomic cancer test portfolio.
The test is covered for serial use in patients with colorectal cancer in the adjuvant and recurrence monitoring settings over a five-year period.
The firms will distribute NowDx's First to Know test to more than 15 organizations nationwide, including LGBTQ+ health centers, HIV/AIDS care providers, and safety net clinics.
NEW YORK – A Delaware-based physician has been accused of filing more than 100 false claims to Medicare for unnecessary genetic cancer screening tests. The US Attorney's Office for the District of ...
NEW YORK — Quanterix said Tuesday that it has closed its acquisition of Akoya Biosciences, issuing roughly 7.8 million shares of common stock and paying approximately $20 million to holders of Akoya ...
The Tulane team has developed a handful of other assays for TB detection, including a mass spec test for paucibacillary TB ...
NEW YORK — Laboratory Corporation of America and NowDiagnostics (NowDx) said Tuesday that they have launched an initiative to distribute NowDx's First to Know Syphilis test at no cost to ...
NEW YORK – In vitro diagnostic firm Leinco Technologies announced on Monday that it has acquired BioClin's proprietary antibody clones used as IVD raw materials, expanding Leinco's portfolio of ...
The acquisition was opposed by some Quanterix shareholders. In May, Akoya also said it received an unsolicited acquisition bid for the firm.
The test is used for the detection of antibodies against Borrelia burgdorferi in serum from patients with signs, symptoms, and clinical history consistent with Lyme disease.
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