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Manufacturer Doesn’t Expect Zika Blood-Screening Test Shortage

 
• By Elizabeth Orr

US FDA has asked Miami-area blood banks to close until they can screen all blood supplies for the Zika virus in the wake of the first known cases transmitted by mosquitos within the US. A manufacturer of the only test currently available for blood-bank use does not expect shortages, despite the increased demand.

The manufacturer of the only Zika blood screening test on the US market doesn’t expect mandatory Zika virus screening at Miami-area blood banks to cause any short-term Zika test shortages.

Hologic Inc. co-developed the Procleix Zika, which runs on the Procleis Panther system, with Grifols SA. FDA cleared...

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

 
• By Natasha Barrow

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

 
• By Natasha Barrow

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.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

More from Diagnostics

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

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.

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

 
• By Natasha Barrow

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.