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The company sells a number of next-generation sequencing-based tissue and liquid biopsy tests for cancer therapy selection to the Chinese market.
By combining with ArcherDX, Invitae will gain tumor profiling and liquid biopsy technologies for predicting and monitoring therapeutic response.
The findings underscore the utility of universal germline testing in young adults diagnosed with cancers that are more common in older populations.
The tests are designed to detect regions in the SARS-CoV-2 genome in respiratory samples or antibodies against the virus in human serum, plasma, or blood.
Progenity recently agreed to pay millions to three major insurers under settlement agreements related to allegations over undisclosed past business practices.
The firm has granted the underwriters an option to purchase up to 2,400,000 additional shares, which would contribute additional gross proceeds of up to $38.4 million.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
News items for the in vitro diagnostics industry for the week of June 15, 2020.
Epredia will soon begin distributing Lunaphore's microfluidic LabSat Research platform for rapid immunohistochemistry and immunofluorescence.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The company will donate full laboratory set-ups to the effort and provide training and education to implement screening programs.
ArcherDX said the firms aim to apply minimal residual disease monitoring in clinical-trial protocols and for future therapy optimization.
The warning letters may signal increased vigilance from the FDA against firms offering coronavirus antibody tests that it believes could harm consumers.
The move is intended to increase testing for COVID-19 and may help conserve resources, which were a major problem during the height of the pandemic.
The suit comes shortly after Progenity filed for an initial public offering in which it is seeking to raise up to $122.6 million.
Ortho offers a total antibody test detecting all COVID-19 related antibodies and an IgG antibody test, both of which received Emergency Use Authorization in April.
The funds will support a platform for rapid bacterial identification and antimicrobial resistance testing.
The Rida Gene SARS-CoV-2 test runs on the Roche LightCycler 480II and is intended for use in hospital, reference, private, and state laboratories.
The novel blood test uses vibrational spectroscopy and metabolomic analysis to differentiate patients with fibromyalgia from those with other autoimmune disorders.
Applied BioCode's test may be performed by any CLIA-certified lab, while Kaiser Permanente's and Emory's must be run at their developers' labs.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The FDA said that data from the company and an independent evaluation of the test found a higher than expected rate of false results.
In April the firm received notice that it wasn't in compliance because its common stock didn't maintain a minimum bid price of $1.00 for 30 consecutive business days.
The company is providing DNA/RNA extraction kits, viral RNA isolation platforms, workstations, and kits for detecting nucleic acids from the coronavirus to the lab.
The effort aims to screen for SARS-CoV-2 in the San Diego community and study the virus' genome to better understand how it is transmitted.