US approves MeMed test to distinguish bacterial from viral infections
The test is designed to indicate whether a person is suffering from a bacterial or viral infection within 15 minutes.
Diagnostics
FDA alerts potential false positive results with Abbott’s Covid-19 tests
The FDA attributed the false positive results to potential mixing parameters that could cause PCR...
Covid-19 testing firm Prenetics agrees to go public with SPAC merger
The company will use the merger proceeds to support continued growth and geographic expansion.
FDA approves Thermo Fisher’s companion diagnostic for Takeda’s NSCLC drug
Oncomine Dx Target Test can analyse 23 genes linked to NSCLC and is FDA-approved as...
Exact Sciences partners with NSABP for validation study of ctDNA test
The study will involve nearly 750 stage II and III colorectal cancer patients in the...
Mesa Labs agrees to acquire Agena Bioscience for $300m
On closing the deal, Agena CEO Peter Dansky will head Mesa’s new Clinical Genomics Division.
FDA grants EUA to Cepheid’s rapid Covid-19/Flu/RSV diagnostic test
Xpert Xpress CoV-2/Flu/RSV plus works on Cepheid’s GeneXpert Systems and offers results in nearly 36 minutes.
Visby Medical’s Covid-19 RT-PCR test obtains FDA EUA
The pooling protocol allows high-complexity labs to combine and process up to five samples into a single device.
ZOLL Medical agrees to acquire Itamar Medical for $538m
Itamar Medical expects ZOLL Medical's commercial footprint to bolster the availability of its home sleep medicine.
Japan approves Oncomine test as CDx with lung cancer medication
Oncomine Dx Target Test can identify specific genetic changes in tumours found in patients with non-small cell lung cancer.
UK NHS commences trial of Grail’s blood test for 50 cancer types
The world’s largest Galleri blood test trial will enrol 140,000 participants from across England to assess the test's efficacy.
