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AACC 2020: COVID-19 Paved Way For ‘Retailization,’ Innovation In Point-Of-Care Testing, Now What?

 
• By Marion Webb

A panel discussed opportunities and challenges in POC testing beyond the pandemic, including the consumer-centric health care environment and continued innovation.

Corona Test

The pandemic has ushered in a new era in point-of-care (POC) testing in which technologies are increasingly becoming more accessible, more affordable and more convenient, putting the consumers’ needs first.

A panel of experts at the recent American Association for Clinical Chemistry meeting, which focused on disruptive technologies in POC...

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• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
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Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
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SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

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GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
• By Shubham Singh

GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.

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DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
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Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.