Menu

Theranos Withdraws Zika Blood Test

The embattled company failed to include proper safeguards, according to federal regulators.

Sep 1, 2016
Jef Akst

Elizabeth Holmes, CEO and founder of TheranosWIKIMEDIA, GLENN FAWCETTTheranos’s best hope for a comeback—a blood-based test called miniLab—is already in hot water. According to a news release, Theranos researchers demonstrated the success of their Zika blood test on the device, but officials at the US Food and Drug Administration (FDA) now say that the company did not implement proper patient-safety protocols, The Wall Street Journal (WSJ) reported. Theranos, which made headlines earlier this year for troubles with substandard laboratory conditions and allegations of criminal activity, has now withdrawn its request for emergency clearance of the Zika test.

“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” Dave Wurtz, Theranos’s vice president of regulatory, quality and clinical affairs, told WSJ.

When CEO Elizabeth Holmes, who was banned from operating a lab for two years after the company was caught selling inaccurate blood tests to consumers, announced the miniLab’s launch at the American Association for Clinical Chemistry (AACC) conference earlier this month (August 1), she claimed that the blood-based test would one day be able to run 160 different assays, from lipid panels to Zika tests. That same day, the company put out a press release stating that it had already tested the device on blood samples collected by finger pricks from patients, including those in the Dominican Republic, and had submitted “validation data for this Zika assay to the FDA for an Emergency Use Authorization.” But according to sources cited by the WSJ, some data in that submission had not followed review-board-approved protocols.

“As with the last phases, Theranos’ implementation of the miniLab may have played too fast and loose with federal regulations,” The Verge reported.

According to WSJ, Theranos investors received an email from the company last Saturday stating that it plans to collect additional data and resubmit an FDA application for emergency clearance of the Zika test, and that it would eventually do the same for an Ebola test.

July 2019

On Target

Researchers strive to make individualized medicine a reality

Marketplace

Sponsored Product Updates

Overcoming the Efficiency Challenge in Clinical NGS
Overcoming the Efficiency Challenge in Clinical NGS
Download this white paper to see how an ECS lab serving a network of more than 10,000 healthcare providers integrated QIAGEN Clinical Insight (QCI) Interpret to significantly reduce manual variant curation efforts and increase workflow efficiency by 80%!
Veravas Launches Product Portfolio to Mitigate Biotin Interference and Improve Diagnostic Assay Accuracy
Veravas Launches Product Portfolio to Mitigate Biotin Interference and Improve Diagnostic Assay Accuracy
Veravas, Inc., an emerging diagnostic company, launched a portfolio of products that can improve the accuracy of current diagnostic test results by helping laboratory professionals detect and manage biotin interference in patient samples with VeraTest Biotin and VeraPrep Biotin.
New Data on Circulating Tumor DNA as a Biomarker for Detecting Cancer Progression Presented at 2019 ASCO Annual Meeting
New Data on Circulating Tumor DNA as a Biomarker for Detecting Cancer Progression Presented at 2019 ASCO Annual Meeting
Scientists presented more than 30 abstracts featuring Bio-Rad’s Droplet Digital PCR (ddPCR) technology at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31–June 4.
BellBrook Labs Receives NIH Grant for the Discovery of cGAS Inhibitors to Treat Autoimmune Diseases
BellBrook Labs Receives NIH Grant for the Discovery of cGAS Inhibitors to Treat Autoimmune Diseases
The National Institute Of Allergy And Infectious Disease recently awarded BellBrook Labs a $300,000 Small Business Innovative Research (SBIR) grant to develop novel inhibitors for the target cyclic GAMP Synthase (cGAS). The grant will be used to accelerate the discovery of new treatments for autoimmune diseases by targeting the cGAS-STING pathway.