Could the FDA take an indirect approach to regulate LDTs?

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

By Susan Kelly • June 16, 2025

Quest partners with MD Anderson to develop cancer risk blood test

Quest plans to refine, develop and validate the technology and is aiming to launch the test in North America next year.

By Nick Paul Taylor • June 13, 2025

Caris Life Sciences plans $424M IPO

Caris, which offers tools for disease diagnosis, therapy selection and treatment monitoring, is the latest company to test the medtech IPO market.

By Susan Kelly • June 10, 2025

Freenome posts pivotal liquid biopsy data as FDA filing nears completion

Freenome plans to complete all modules of its premarket approval submission in mid-2025.

By Nick Paul Taylor • June 4, 2025

Clairity receives FDA OK for breast cancer risk prediction tool

The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict breast cancer risk over five years.

By Elise Reuter • June 3, 2025

FDA declines to appeal court order that stopped LDT final rule

“The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen analysts wrote.

By Susan Kelly • June 3, 2025

AstraZeneca drug could help keep a common breast cancer at bay

Data presented at ASCO show that swapping in the oral drug camizestrant for an older therapy helped sustain the benefit of initial treatment, potentially opening a novel step in patient care.

By Ned Pagliarulo • June 2, 2025

Teal posts data on newly approved at-home cancer screening device

Self-collection correctly identified 95.2% of HPV samples that are associated with increased cancer risk.

By Nick Paul Taylor • May 20, 2025

FDA clears first blood test to aid Alzheimer’s diagnosis

The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

By Nick Paul Taylor • May 19, 2025

SEC ends probe of Illumina’s Grail acquisition

The DNA sequencing company also cut its 2025 earnings outlook to reflect the impact of tariffs on its business.

By Susan Kelly • May 9, 2025

Danaher predicts $350M tariff hit, moves to mitigate impact on profits

The company is planning manufacturing footprint changes, supply chain adjustments, surcharges and cost cutting to limit the impact of the tariffs.

By Nick Paul Taylor • April 24, 2025

Illumina, Tempus AI partner to drive genomic testing beyond cancer

The partners plan to build evidence packages that standardize comprehensive genomic profiling and other molecular testing across all major diseases.

By Nick Paul Taylor • April 18, 2025

A judge blocked the FDA’s plan to regulate LDTs. What now?

One attorney said the ruling “isn’t quite the stake in the heart.”

By Susan Kelly • April 16, 2025

Cepheid to lay off 167 people in California

The company laid off more than 1,300 people in California in 2023 and 2024 as respiratory sales fell from the peak hit during the pandemic.

By Nick Paul Taylor • April 14, 2025

China probes US-made CT tubes after Trump hikes tariffs

The investigation indicates that China will likely favor local medtech companies over foreign competition amid international economic tensions, a J.P. Morgan analyst said.

By Elise Reuter • Updated April 9, 2025

Labcorp launches blood test to accelerate Alzheimer’s diagnosis

Manufacturers of Alzheimer’s disease drugs have identified blood tests as a way to accelerate diagnosis and treatment.

By Nick Paul Taylor • April 7, 2025

Tariffs send healthcare industry into ‘unchartered waters’

Provider groups and health systems warn tariffs will test healthcare’s fragile supply chain. Wall Street, meanwhile, said medtech businesses will face pressure, particularly diabetes tech firms.

By Susanna Vogel , Susan Kelly • April 4, 2025

Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

By Susan Kelly • April 1, 2025

FDA OKs first at-home test for 3 STIs

Visby Medical’s at-home diagnostic, which can be purchased without a prescription, tests for chlamydia, gonorrhea and trichomoniasis.

By Nick Paul Taylor • March 31, 2025

23andMe files for bankruptcy; CEO Anne Wojcicki resigns

The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

By Elise Reuter • March 24, 2025

Labcorp to close Los Angeles site, lay off 73 people

Labcorp lists the plant as part of its consumer genetics business and plans to begin eliminating positions in May.

By Nick Paul Taylor • March 24, 2025

Quest, Google team on gen AI; GE Healthcare plans autonomous imaging

GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.

By Nick Paul Taylor • Updated March 20, 2025

Spectral AI algorithms beat physicians in burn tissue assessments

The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.

By Nick Paul Taylor • March 18, 2025

Labcorp to buy Opko unit’s cancer test assets for up to $225M

Labcorp will acquire BioReference Health's oncology diagnostics operations as the lab company works to expand in high-growth testing areas.

By Susan Kelly • March 12, 2025

CAP urges HHS to revoke lab developed test rule, citing Trump order

The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”

By Nick Paul Taylor • Feb. 26, 2025