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The investment firm said that Grail's revenue trajectory is uncertain, and given the firm's operating loss, it will significantly dilute Illumina's earnings.

The test is designed to detect two regions within the virus' nucleocapsid gene in upper respiratory specimens, according to the Puerto Rico-based company.

Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.

The nonexclusive deal includes Personal Genome Diagnostics' US Food and Drug Administration-cleared Elio Tissue Complete cancer genomic profiling assay.

Along with the downgrade, the investment bank also lowered its December 2021 price target for Illumina from $390 to $280.

As part of the award, Ortho Clinical will develop a rapid SARS-CoV-2 antigen assay and further develop its two FDA-authorized SARS-CoV-2 antibody assays.

The Wilmington, Delaware-based startup will use the funds for clinical validation trials on its Arna Breast cancer diagnostic test in the US and Europe. 

After a two-year evaluation in advanced non-small cell lung cancers with Allegheny Health Network, the payor will cover the test for its regional members.

The deal, which was approved by the boards of directors of both companies, is expected to close in the second half of 2021, pending customary conditions.

An early version of the test is being used by researchers as part of the NIH-funded Chronic Renal Insufficiency Cohort (CRIC) study.

The deal includes UK-based Yourgene's test for detecting cancer patients who may have an adverse reaction to 5-fluorouracil, as well as reproductive health tests.

An initial program aims at the development of a serum neurofilament light chain immunoassay to support Novartis' MS and other neuroscience programs.

One of the revisions specifies that the ID Now test is for use with specimens collected within the first week of symptom onset.

The agency confused and upset many in the healthcare community last month when it said asymptomatic patients did not need to be tested.

The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.

The tests will be developed to identify NSCLC patients with ALK fusions and EGFR Exon20 insertion mutations who respond to mobocertinib or brigatinib.

Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.

The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.

News items for in vitro diagnostics industry for the week of Sept. 14, 2020.

In 2018 Qiagen purchased a 19.9 percent stake in Ann Arbor, Michigan-based NeuMoDx along with the right to acquire the remaining shares.

The Manhattan-based lab will scale its capacity to process 20,000 tests per day by November and provide results dedicated to the city.

Ambry will provide RNA sequencing for Scipher's PrismRA blood test to predict response to TNF inhibitor therapies in rheumatoid arthritis patients.

The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.

AACC noted that the number of sites performing clinical lab testing in the US has risen to 266,000 in 2020 from 154,000 in 1993.

The company holds a leading position in reproductive testing and is expected to rapidly grow its oncology business to address a total market of $21 billion.

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