Diagnostics

In response to the escalating spread of the virus nationwide, the Biden administration declared that it would recommence offering free at-home COVID tests to American households starting next Monday. Last September, the federal government suspended its offer of free at-home COVID-19 tests....

An investigation by the UK's Health Security Agency (UKHSA) found the Immensa laboratory to have misreported around 39,000 tests as negative when they should have been positive between September 2 and October 12, 2021. The cause of the mistakes was the incorrect setting of the threshold levels...

Virax Biolabs Group Ltd (NASDAQ: VRAX) has launched the RSV-Influenza-COVID Triple Virus Antigen Rapid Test Kit in the European Union. What Happened: The test kits are used at home and in point-of-care settings to accurately identify infections related to a respiratory syncytial virus (...

Roche Holdings AG (OTC: RHHBY) has announced the launch of its next-generation portfolio of COVID-19 rapid antigen tests (2.0) for self-testing and professional use in countries accepting the CE Mark.  Distribution of the new rapid test portfolio is projected to begin in the...

The FDA said it will now review only a small number of emergency use authorization (EUA) requests for COVID-19 diagnostic tests. The agency encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k)...

Cue Health Inc (NASDAQ: HLTH) announced the preprint publication of an independent clinical study demonstrating that its point of care (POC) molecular COVID-19 test is as accurate as a centralized lab-based RT-PCR.  Cue's molecular test produces results in...

Talis Biomedical Corporation (NASDAQ: TLIS) discontinued investment in the commercialization of its stand-alone COVID-19 assay under Emergency Use Authorization. The company cited evolving market dynamics with COVID testing and the current financial environment. Related: ...

The FDA has authorized the first nonprescription test to detect Covid-19, influenza, and respiratory syncytial virus (RSV). The test, called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, was developed by Laboratory Corp of America Holdings (NYSE: LH). It can be sold...

Quest Diagnostics Inc (NYSE: DGX) posted a better-than-expected Q1 FY22 adjusted EPS of $3.22, down 14.4% Y/Y, beating the consensus of $2.97. Sales came in at $2.61 billion, a decline of 4% Y/Y, slightly lower than the Wall Street estimate of $2.63 billion. COVID-19 testing revenues...

DIOSynVax, a UK start-up, hopes genetic sequences of viruses discovered in animal feces will give vital clues for creating a vaccine to help prevent future pandemics, reports Financial Times. The Cambridge university spinout is working on two vaccines that it believes will outlive the...

The Centers for Disease Control and Prevention (CDC) has granted a contract to Quest Diagnostics Inc (NYSE: DGX) to perform testing and provide laboratory data analysis to help identify patterns in SARS-COV-2 seroprevalence on a multistate basis.  Quest was awarded the...

Twist Bioscience Corporation (NASDAQ: TWST) has launched specific synthetic RNA positive controls for SARS-CoV-2 encapsulated in stainless steel mini capsules that Imagene SA provided.  The airtight mini capsules provide a stable environment for the RNA controls,...

Talis Biomedical Corp (NASDAQ: TLIS) said that it had not started its phased launch of the Talis One COVID-19 Test System due to challenges with manufacturing.  The company has engaged in a manufacturing review process to determine appropriate next steps and initiatives to...

According to an SEC filing, Lucira Health Inc (NASDAQ: LHDX) has terminated a Patent License with Eiken Chemical Co Ltd, effective May 12, 2022. The Company terminated the agreement because certain Eiken Licensed Patents have expired, all of which are locations in which the Company...

Twist Bioscience Corp (NASDAQ: TWST) and Eleven Therapeutics have created a replicon tool that could be used for studying viral genome replication, antiviral drug screening, and vaccine & therapeutic development. Replicons are synthetic viral RNA molecules that mimic...