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360Dx

@360dx.bsky.social

Real-time news on the IVD market from the publishers of GenomeWeb. Read the latest news at 360Dx.com.

42 Followers  |  18 Following  |  1,213 Posts  |  Joined: 13.12.2024  |  1.726

Latest posts by 360dx.bsky.social on Bluesky

With €46M in Funding, Deciphex Expands Digital Pathology Toolset and Reach The Dublin-based firm is developing an array of artificial intelligence-derived tools to improve the efficiency of its digital pathology outsourcing service.

www.360dx.com/tissue-based...

31.10.2025 13:47 — 👍 0    🔁 0    💬 0    📌 0
Tosoh Bioscience Gets FDA 510(k) Clearance for Automated HbA1c Analyzer The high-performance liquid chromatography-based analyzer is designed for use in mid- to high-volume labs.

www.360dx.com/regulatory-n...

31.10.2025 13:47 — 👍 0    🔁 0    💬 0    📌 0
Provider Organizations Issue Letter to Congress Urging Passage of PAMA Reform Bill Called the RESULTS Act, the bill would use a third-party database to set Medicare payment rates and would delay price cuts and data reporting scheduled for 2026.

www.360dx.com/policy-legis...

31.10.2025 13:25 — 👍 0    🔁 0    💬 0    📌 0
In Brief This Week: Thermo Fisher Scientific, Augurex Life Sciences, APIS Assay Technologies News items for the week of Oct. 27, 2025

www.360dx.com/business-new...

31.10.2025 12:44 — 👍 0    🔁 0    💬 0    📌 0
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Sequencing, Proprietary Assays, and Infectious Disease MDx Drive Clinical Lab Growth Post-COVID Medicare Part B data show that of the 20 CPT codes seeing the largest increase in payments from 2022 to 2024, all are for molecular- or sequencing-based tests.

www.360dx.com/clinical-lab...

30.10.2025 21:20 — 👍 0    🔁 0    💬 0    📌 0
KICK OFF EVENT @ AMP 2025 Join GenomeWeb and Foundation Medicine to kick off AMP 2025!

Join GenomeWeb at AMP in Boston in two weeks. Come by for a drink and some snacks.
www.eventbrite.com/e/kick-off-e...

30.10.2025 20:31 — 👍 0    🔁 0    💬 0    📌 0
Imperial College Spinout ProtonDx Advances Commercial Rollout of Malaria Test and POCT Instrument The company's Dragonfly instrument uses a proprietary sample preparation method and isothermal amplification to diagnose a variety of infectious diseases.

www.360dx.com/molecular-di...

30.10.2025 17:51 — 👍 0    🔁 0    💬 0    📌 0
Guardant Health Enters Multi-Cancer Blood Screening Market as Stock Soars on Q3 Earnings The company said that use of its Shield MCD test for colorectal cancer has been expanding, and it now aims to collect real-world data on adoption for multi-cancer screening.

www.360dx.com/cancer/guard...

30.10.2025 17:50 — 👍 0    🔁 0    💬 0    📌 0
Celebrating Five Years on Nasdaq, Biodesix Branches Out The Colorado firm is expanding its partnerships, outreach efforts, technology applications, and sales force for its oncology screening and monitoring test business.

www.360dx.com/business-new...

30.10.2025 17:50 — 👍 0    🔁 0    💬 0    📌 0
Bio-Rad Laboratories Q3 Revenues Rise 1 Percent The firm is projecting a gradual recovery of the academic market in the face of ongoing funding uncertainties and a government shutdown.

www.360dx.com/business-new...

30.10.2025 17:49 — 👍 0    🔁 0    💬 0    📌 0
Detact Diagnostics Secures $1.6M Gates Foundation Grant for Syphilis Test Development The Netherlands-based company will develop a low-cost, rapid point-of-care test using its Visualization by Infrared PEptide Reaction (VIPER) technology.

www.360dx.com/business-new...

30.10.2025 17:49 — 👍 0    🔁 0    💬 0    📌 0
Gradientech Rapid AST Platform, Gram-Negative Panel Receive IVDR Certification The certification applies to Gradientech's Class B QuickMIC GN AST panel for Gram-negative bacteria, along with the entire diagnostic platform.

www.360dx.com/regulatory-n...

30.10.2025 17:48 — 👍 0    🔁 0    💬 0    📌 0
Qiagen Gets Expanded FDA Clearance for Fecal Swab Samples on Syndromic System The firm's full and mini gastrointestinal panel tests can now be used with fecal swab samples to detect pathogen nucleic acids.

www.360dx.com/regulatory-n...

30.10.2025 17:48 — 👍 0    🔁 0    💬 0    📌 0
Archerfish Precision Diagnostics to Distribute Clearnote Health Liquid Biopsy Test in Asia Archerfish is working to build awareness and provide access to Clearnote's Avantect early cancer detection platform for pancreatic and ovarian cancer screening.

www.360dx.com/cancer/arche...

29.10.2025 14:41 — 👍 0    🔁 0    💬 0    📌 0
Global Health Innovative Technology Fund Awards ¥1.73B for TB, Tropical Disease, Malaria Projects The projects include the development of rapid diagnostic tests for tuberculosis, Strongyloides stercoralis, and malaria.

www.360dx.com/infectious-d...

29.10.2025 14:28 — 👍 0    🔁 0    💬 0    📌 0
Roche Automated Dengue Test Receives CE Mark The high-throughput antigen test includes all four dengue virus serotypes and returns results in about 18 minutes.

www.360dx.com/regulatory-n...

29.10.2025 14:11 — 👍 0    🔁 0    💬 0    📌 0
EazeBio, UCSC Partner on Point-of-Care Dx Technology The partners will begin with work on a cortisol biosensor that can be used for stress and metabolic health testing.

www.360dx.com/business-new...

29.10.2025 14:11 — 👍 0    🔁 0    💬 0    📌 0
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Chronic Disease Dx Firm Curve Biosciences Emerges From Stealth With $40M Financing Round

Chronic Disease Dx Firm Curve Biosciences Emerges From Stealth With $40M Financing Round

29.10.2025 13:46 — 👍 0    🔁 0    💬 0    📌 0
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Chronic Disease Dx Firm Curve Biosciences Emerges From Stealth With $40M Financing Round The company is developing blood tests for chronic diseases using artificial intelligence models and a database of more than 400,000 tissue samples.

www.360dx.com/business-new...

29.10.2025 13:38 — 👍 0    🔁 0    💬 0    📌 0
Burst Diagnostics, FemmeLoop Nab $301K NIH Grant for Home-Use Perimenopause Test The companies will use the Phase I Small Business Innovation Research (SBIR) grant to support the development of a urine-based ELISA to inform treatment decisions.

www.360dx.com/immunoassays...

29.10.2025 13:38 — 👍 0    🔁 0    💬 0    📌 0
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Kentucky's St. Elizabeth Healthcare to Bring Pharmacogenomic Testing In-House

Kentucky's St. Elizabeth Healthcare to Bring Pharmacogenomic Testing In-House

28.10.2025 21:26 — 👍 0    🔁 0    💬 0    📌 0
Co-Diagnostics Prices $7M Direct Offering The Salt Lake City-based molecular diagnostics developer is offering nearly 13 million shares of its common stock at $.55 per share.

www.360dx.com/business-new...

28.10.2025 20:12 — 👍 0    🔁 0    💬 0    📌 0
GeneDx Rolls out Strategy for Capturing General Pediatrics Market as Genomic Testing Takes off Fueled by the American Academy of Pediatrics' recent guideline update, GeneDx is building out a dedicated sales team for the general pediatrics market.

www.360dx.com/sequencing/g...

28.10.2025 20:11 — 👍 0    🔁 0    💬 0    📌 0
Experts Question Grail's Galleri Performance Data at ESMO Those closely following the development of the MCED test challenged Grail's positive predictive value calculation and the metrics the firm chose to publicly highlight.

www.360dx.com/cancer/exper...

28.10.2025 20:11 — 👍 0    🔁 0    💬 0    📌 0
NeoGenomics Q3 Revenues up 12 Percent The company cited continued growth in clinical test volume, as well as better per-test revenues as major drivers of its year-over-year improvement.

www.360dx.com/molecular-di...

28.10.2025 20:10 — 👍 0    🔁 0    💬 0    📌 0
Labcorp Q3 Revenues Grow 9 Percent Total revenues for the three months ended Sept. 30 were $3.56 billion, up from $3.28 billion in the third quarter of 2024 and matching the consensus Wall Street estimate.

www.360dx.com/business-new...

28.10.2025 15:19 — 👍 0    🔁 0    💬 0    📌 0
Proteomics International Q3 Revenue Grows Sevenfold on University of Western Australia Deal The deal, which is nonrecurring, accounted for roughly A$1.7 million of the A$1.9 million in revenue the company posted in Q3 2025.

www.360dx.com/business-new...

28.10.2025 13:56 — 👍 0    🔁 0    💬 0    📌 0
Cepheid Tuberculosis Drug Resistance Test Receives WHO Prequalification The designation affirms the test's compliance with the WHO's standards for quality, safety, and performance.

www.360dx.com/molecular-di...

28.10.2025 13:56 — 👍 0    🔁 0    💬 0    📌 0
UPDATE: Newborn Screening a Bright Spot as Revvity's Reproductive Health Business Drives Q3 Dx Growth The firm posted 2 percent overall revenue growth as strength in Europe and the Americas was offset by softness in China and the rest of Asia.

www.360dx.com/business-new...

27.10.2025 18:12 — 👍 0    🔁 0    💬 0    📌 0
Co-Diagnostics, Arabian Eagle Manufacturing Establish Joint Venture in Saudi Arabia The JV will commercialize Co-Diagnostics' products, including its in-development point-of-care molecular diagnostics system, in Saudi Arabia and 18 other MENA countries.

www.360dx.com/business-new...

27.10.2025 14:42 — 👍 0    🔁 0    💬 0    📌 0

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