Diagnostics: Page 7
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Permission granted by Abbott
Abbott wins FDA clearance for bedside blood concussion test
The clearance is a step towards using the test in non-healthcare settings, such as sporting events, Abbott said.
By Nick Paul Taylor • April 2, 2024 -
Courtesy of Exact Sciences
Exact Sciences, Mayo Clinic share early data on esophageal cancer test
Designed as an alternative to endoscopy, the cancer screening test uses a sponge collection device that's paired with an algorithm.
By Elise Reuter • March 29, 2024 -
Courtesy of Labcorp
Labcorp inks $237.5M buyout of Opko’s reproductive, women’s health testing assets
The acquired assets generate about $100 million in annual revenue, according to the deal announcement.
By Nick Paul Taylor • March 29, 2024 -
Courtesy of Hologic
Hologic to lay off 190 workers as it closes European facilities
Three months after announcing unspecified international facility closures, Hologic has disclosed the number of affected employees and estimated $12.2 million in severance costs.
By Susan Kelly • Updated May 6, 2024 -
Courtesy of Roche
Roche wins FDA approval for first molecular malaria blood donor screening test
The company is pitching the test as a way to improve the safety and availability of blood.
By Nick Paul Taylor • March 28, 2024 -
Courtesy of Illumina
Court adviser sides with Illumina in EU row that triggered Grail fine
Illumina is still planning to divest Grail but may escape a fine of about 432 million euros imposed by the European Commission.
By Nick Paul Taylor • March 25, 2024 -
3000ad via Getty Images
As FDA’s LDT rule looms, experts warn patients may lose access to critical tests
In testimony to Congress Thursday, industry and patient group leaders described the trade-offs expected from increased FDA oversight of laboratory-developed tests.
By Susan Kelly • March 22, 2024 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher, Bayer partner to develop companion diagnostics
The companies aim to identify potential patients for Bayer’s precision cancer therapies and increase access to the treatments.
By Nick Paul Taylor • March 21, 2024 -
Courtesy of Siemens Healthineers
Siemens Healthineers to close fast track diagnostics unit, lay off about 90 workers
Demand for the products peaked during the COVID-19 pandemic but has fallen away since then.
By Nick Paul Taylor • March 19, 2024 -
Courtesy of Business Wire
Guardant posts data for colon cancer blood test amid push from rivals
The NEJM paper presents data from a study of more than 10,000 people Guardant ran to support authorization of its Shield DNA test.
By Nick Paul Taylor • March 18, 2024 -
Permission granted by QuidelOrtho
QuidelOrtho to lay off employees after firing CEO
Interim CEO Michael Iskra said in a recent presentation to investors the diagnostics firm plans to lay off less than 10% of its staff.
By Susan Kelly • March 14, 2024 -
Stock via Getty Images
FDA panel backs Lumicell’s agent for breast cancer imaging tool
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
By Nick Paul Taylor • March 11, 2024 -
Courtesy of Dexcom
Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices
The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.
By Nick Paul Taylor • March 4, 2024 -
Permission granted by Becton Dickinson
BD life sciences president Dave Hickey to retire July 1
The company has yet to name Hickey’s replacement but plans to have a successor in place before the executive retires.
By Nick Paul Taylor • Feb. 28, 2024 -
iStock via Getty Images
Natera secures Medicare coverage for cancer test in 2 new indications
Natera met the coverage requirements for ovarian cancer in adjuvant and surveillance settings and for breast cancer in the neoadjuvant setting.
By Nick Paul Taylor • Feb. 27, 2024 -
Carl Court via Getty Images
European Council approves extension of IVDR transition
The Council expects the European Parliament to vote on the plan, without seeking amendments, in April.
By Nick Paul Taylor • Feb. 26, 2024 -
Permission granted by QuidelOrtho
QuidelOrtho fires CEO Doug Bryant
Bryant, who led the company since 2009, was fired after a challenging quarter and confusion over earnings forecasts.
By Elise Reuter • Feb. 21, 2024 -
UK medical device reviewers form new association
The group intends to help the medical device sector navigate a post-Brexit regulatory landscape.
By Susan Kelly • Feb. 20, 2024 -
K-Kwanchai via Getty Images
Freenome raises $254M to study cancer screening tests
Roche and Quest Diagnostics were among those to invest in the company’s development of early cancer detection blood tests.
By Nick Paul Taylor • Feb. 16, 2024 -
Getty Images via Getty Images
Invitae files for Chapter 11 bankruptcy
The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.
By Elise Reuter • Feb. 14, 2024 -
Courtesy of Cue Health Press Kit
Cue Health axes more jobs amid declining test sales
The company cut 94 workers at the beginning of last month and another 151 people on Jan. 25.
By Elise Reuter • Feb. 9, 2024 -
Permission granted by Illumina
Illumina cut 12% of global staff over past year: CEO
The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.
By Susan Kelly • Feb. 9, 2024 -
Courtesy of Illumina
Illumina to lay off 111 people at San Diego headquarters
The job cuts, expected by March 12, include senior management positions, scientists and engineers.
By Susan Kelly • Feb. 8, 2024 -
Stock via Getty Images
Invitae hires advisers, considers bankruptcy: WSJ
Sources told the Wall Street Journal a bankruptcy filing could come within weeks.
By Susan Kelly • Feb. 7, 2024 -
Sarah Silbiger via Getty Images
Hologic wins FDA clearance for AI-enabled cervical cancer screening system
The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.
By Nick Paul Taylor • Feb. 5, 2024
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