Diagnostics
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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 -
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 -
Trendline
Medical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
FDA to reclassify most high-risk IVDs, easing path to clearance
The effort comes ahead of the regulator’s plan to finalize a rule that would expand its oversight of laboratory-developed tests.
By Susan Kelly • Feb. 5, 2024 -
Califf backs increased LDT oversight despite industry opposition
At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.
By Ricky Zipp • Feb. 1, 2024 -
BD partners with Techcyte to offer AI-enhanced cervical cancer screening
Techcyte has developed a system to reduce the amount of cells pathologists need to review.
By Nick Paul Taylor • Feb. 1, 2024 -
Agilent, Incyte to partner on companion diagnostics
The collaboration comes after Agilent restructured and sold its liquid biopsy unit.
By Elise Reuter • Jan. 30, 2024 -
Abbott says all four segments stronger than pre-pandemic
CEO Robert Ford said investing in its base business using COVID-19 testing revenues was “absolutely the right strategy.”
By Elise Reuter • Jan. 24, 2024