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360Dx
@360dx.bsky.social
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Real-time news on the IVD market from the publishers of GenomeWeb. Read the latest news at 360Dx.com.
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The ignorance and data denialism of FDA intent of putting a black box on Covid vaccines when the evidence of benefit is overwhelming, even among children
www.cdc.gov/mmwr/volumes...
December 12, 2025 at 5:10 PM
360dx.bsky.social
www.360dx.com/cancer/exact...
Exact Sciences Provides First Look at MRD Test Performance in Triple-Negative Breast Cancer
At SABCS, researchers reported data showing Oncodetect can identify patients who are unlikely to experience distant recurrence three years after surgery.
www.360dx.com
December 12, 2025 at 3:53 PM
360dx.bsky.social
www.360dx.com/cancer/fda-p...
FDA Proposal to Reclassify CDx Assays May Broaden Opportunities for Dx Manufacturers, Experts Say
The agency proposed down-classifying companion diagnostic assays to Class II devices from Class III devices.
www.360dx.com
December 12, 2025 at 2:53 PM
360dx.bsky.social
www.360dx.com/cancer/astri...
Astrin Biosciences Applying Plasma Proteomics Platform to Cancer Testing
The firm presented data at the San Antonio Breast Cancer Symposium this week on its test for screening women with dense breasts that it plans to launch early next year.
www.360dx.com
December 12, 2025 at 2:52 PM
360dx.bsky.social
www.360dx.com/cancer/nater...
Natera, MEDSIR to Collaborate on MiRaDoR Breast Cancer Trial
The multicenter phase II clinical trial in hormone receptor-positive, HER2-negative breast cancer will use Signatera Genome to guide treatment approaches.
www.360dx.com
December 12, 2025 at 2:51 PM
360dx.bsky.social
www.360dx.com/business-new...
In Brief This Week: Guardant Health, Danaher, DNAe, Yikon Genomics
News items for the week of Dec. 8, 2025
www.360dx.com
December 12, 2025 at 2:43 PM
360dx.bsky.social
www.360dx.com/cancer/nater...
Natera Aims to Boost Signatera Sensitivity, Expand Into Hematologic Cancer Space With Foresight Dx Buy
The firm plans to introduce Foresight Diagnostics' phased variants technology to its Signatera solid tumor assay.
www.360dx.com
December 11, 2025 at 3:50 PM
360dx.bsky.social
www.360dx.com/cancer/caris...
Caris, Cooperative Groups Advancing AI Models That Can Improve Breast Cancer Risk Assessments
At SABCS, researchers shared data showing a model weighing clinical, molecular, and imaging features may better identify patients at risk of distant recurrence.
www.360dx.com
December 11, 2025 at 3:49 PM
360dx.bsky.social
www.360dx.com/regulatory-n...
Roche Receives CE Mark for Antibiotics Drug Monitoring Assay on Cobas Mass Spec System
With the approval, the company's automated clinical mass spec system, the Cobas I 601 analyzer, features an in vitro diagnostic menu of 39 tests.
www.360dx.com
December 11, 2025 at 2:50 PM
360dx.bsky.social
www.360dx.com/cancer/guard...
Guardant Health, Trial Library Partner to Expand Access to Cancer Clinical Trials
The collaboration combines Guardant's diagnostics with Trial Library's AI-powered matching and patient navigation platform.
www.360dx.com
December 11, 2025 at 2:49 PM
360dx.bsky.social
www.360dx.com/business-new...
Macula Vision Systems Raises $1.7M to Commercialize In AI-Enabled Microscopy System
The company intends to use the funding to advance its AI-powered microscopy system for infectious disease analysis.
www.360dx.com
December 11, 2025 at 2:49 PM
360dx.bsky.social
Passage of PAMA Reform at Stake With Congressional Budget Office Scoring Changes
Passage of PAMA Reform at Stake With Congressional Budget Office Scoring Changes
www.360dx.com
December 10, 2025 at 10:38 PM
360dx.bsky.social
www.360dx.com/policy-legis...
Passage of PAMA Reform at Stake With Congressional Budget Office Scoring Changes
CBO's recent score tallied temporary PAMA delay as a cost rather than a savings, potentially making future delays less likely but possibly raising the chances of permanent reform.
www.360dx.com
December 10, 2025 at 9:33 PM
360dx.bsky.social
www.360dx.com/immunoassays...
Amplifold Raises €5M to Commercialize DNA Origami Diagnostics
The German startup is developing ultrasensitive lateral flow diagnostic tests that incorporate DNA origami signal amplification.
www.360dx.com
December 10, 2025 at 4:39 PM
360dx.bsky.social
www.360dx.com/business-new...
Quanterix Inks South Korean Distribution Deal for Alzheimer's Disease Testing Instrument, Assays
Quanterix's flagship HD-X Simoa Immunoassay Analyzer was cleared in South Korea earlier this year.
www.360dx.com
December 10, 2025 at 2:47 PM
360dx.bsky.social
www.360dx.com/cancer/billi...
BillionToOne Q3 Revenues More Than Double Year Over Year
The molecular diagnostics firm, which went public on Nov. 6 in a $237 million IPO, reported Q3 revenues of $83.5 million, including $74.1 million from prenatal testing.
www.360dx.com
December 10, 2025 at 2:47 PM
360dx.bsky.social
www.360dx.com/sequencing/r...
Radboud UMC Goes Live With Frontline Diagnostic WGS Test Based on Long Reads
The Dutch healthcare center plans to sequence 5,000 genomes over the next year to help diagnose genetic eye diseases and severe intellectual disability.
www.360dx.com
December 9, 2025 at 10:13 PM
360dx.bsky.social
www.360dx.com/cancer/trill...
TrilliumBio, Oncobit Partner to Offer Uveal Melanoma Monitoring Test in the US
Under the deal, TrilliumBio will offer Oncobit's digital PCR-based uveal melanoma monitoring test through its Rockville, Maryland-based laboratory.
www.360dx.com
December 9, 2025 at 10:13 PM
360dx.bsky.social
www.360dx.com/cancer/vince...
Vincere Cancer Center, Syantra Launch Clinical Study of Breast Cancer Screening Test
The study will evaluate the performance of Syantra's blood-based Onco-ID Breast molecular assay for screening women at elevated risk of breast cancer.
www.360dx.com
December 9, 2025 at 2:58 PM
360dx.bsky.social
www.360dx.com/cancer/uniog...
Uniogen Plans 2027 European Clinical Launch for Early-Stage Ovarian Cancer Test
Uniogen's progress toward clinical commercialization aligns with larger internal goals of bringing cancer diagnostics to market, with a specific focus on women's health.
www.360dx.com
December 9, 2025 at 2:47 PM
360dx.bsky.social
www.360dx.com/infectious-d...
CARB-X Awards $1M Seed Funding for Exhalon's Breath-Based Lower Respiratory Tract Infection Test
The test could potentially deliver noninvasive results in less than one minute through analysis of exhaled volatile organic compounds.
www.360dx.com
December 9, 2025 at 2:47 PM
360dx.bsky.social
www.360dx.com/regulatory-n...
Roche Nabs CE Mark for PCR-Based Vaginitis Assay
The test helps diagnose infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis.
www.360dx.com
December 9, 2025 at 2:47 PM
360dx.bsky.social
www.360dx.com/molecular-di...
Global Health Innovative Technology Fund Invests ¥70M in Molecular Mpox Test
The test, which will use Iso-PAS technology, will be developed by Nipro of Japan in collaboration with other companies, institutes, and nonprofit organizations.
www.360dx.com
December 8, 2025 at 8:33 PM
360dx.bsky.social
www.360dx.com/cancer/pilla...
Pillar Biosciences, AstraZeneca Expand Partnership on Liquid Biopsy Cancer Testing to China
The firms will collaborate with Shanghai Zhengu Biological Technology to support assay validation in Chinese hospital labs and implement Pillar's panels.
www.360dx.com
December 8, 2025 at 4:05 PM
360dx.bsky.social
www.360dx.com/cancer/umc-u...
UMC Utrecht, PathAI Partner on Digital Pathology-Based Research for AI Algorithms
The medical center will use PathAI's AISight Dx image management system to evaluate algorithms for a variety of applications.
www.360dx.com
December 8, 2025 at 4:05 PM