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Access Bio’s CareStart Real Time PCR COVID-19 Test Earns EUA

 
• By Reed Miller

The test, which can be processed in 83 minutes or less, has shown 100% sensitivity and 100% specificity in clinical trials, according to the New Jersey company.

A doctor in a protective suit taking a nasal swab from a person to test for possible coronavirus infection
• Source: shutterstock.com

Access Bio, Inc. is launching its CareStart COVID-19 MDx RT-PCR molecular test to detect the SARS CoV-2 virus following receipt of an emergency use authorization (EUA) from the US Food and Drug Administration, the company announced on 23 July.

CareStart COVID-19 MDx RT-PCR detects nucleic acid sequences unique to SARS-CoV-2 that have been extracted, isolated, and purified from nasopharyngeal...

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More from In Vitro Diagnostics

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs

 
• By Marion Webb

Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 
• By Natasha Barrow

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

More from Diagnostics

Biostate AI Builds Global RNA-AI Pipeline With $12M Boost, Ventures In China And India

 
• By Shubham Singh

Biostate AI has set up an Indian subsidiary, Bayosthiti, to develop cancer and cardiac diagnostics with local hospitals. This follows a joint venture with China's Kindstar Global and mirrors Biostate’s US collaboration with Mass General Brigham to build AI models for melanoma.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 
• By Brian Bossetta

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.