Report: Federal Regulators Find 'Serious Deficiencies' at Theranos' California Lab FacilityThe findings could lead to Theranos' suspension from the Medicare program.

ByGeoff Weiss

Opinions expressed by Entrepreneur contributors are their own.

Pixabay

Jan. 25,5:30 p.m. ET: This story has been updated throughout with comments from Theranos and Walgreens.

An audit by the Centers for Medicare and Medicaid Services (CMS), a federal health agency, has reportedly uncovered "serious deficiencies" at Theranos's lab facility in Newark, Calif.

The details of the audit were not disclosed but are expected to be released soon -- and could result in Theranos tests being suspended from the Medicare program if not promptly redressed, according toThe Wall Street Journal.

CMS told theJournalthat it "can't confirm any survey conclusions or results at this time."

Theranos spokeswoman Brooke Buchanan told雷竞技手机版that the company hadn't received a copy of the final routine audit report, which was conducted last fall. "Unfortunately, the blind sources thatThe Wall Street Journalused didn't tell us where they were from or who they are or what level of access that they have," she said. "It's all allegations at this time."

Theranos's partnership with Walgreens is also hanging ever more in the balance, according to theJournal. Walgreens, which houses 41 Theranos testing facilities in locations throughout Arizona and California, has already suspended expansion of the program until questions about Theranos's technology are resolved, but the facilities face an even greater risk of being shuttered pending the results from CMS's latest inspection.

Buchanan said that these reports are also incorrect. "We are actually looking to expand," she said of Theranos's partnership with Walgreens.

Related:Health Regulators Are Investigating Theranos's Blood Test Technology

A Walgreens spokesman reiterated a former statement to雷竞技手机版that it made last October when the retailer initially halted expansion. "We are currently in discussions about the next phase of our relationship," that statement read. "Plans to open more Theranos Wellness Centers are dependent upon both companies' ability to reach a mutually beneficial arrangement."

Previously, CMS had cited problems following an inspection of Theranos' Newark lab in 2013, which the company said it resolved, as well as infractions last year at another Theranos lab facility in Arizona. But the latest findings are "far more severe," according to theJournal.

Theranos was founded in 2003 by 31-year-old Stanford dropout Elizabeth Holmes and says it can conduct a multitude of blood tests using a tiny sample pricked from a fingertip. The company was last valued at $9 billion.

Currently, Theranos has only received FDA approval to conduct one test using its proprietary technology, for herpes. (As the only lab seeking FDA approval, Buchanan told雷竞技手机版, "that's one more test than anyone else." She added that Theranos is seeking FDA approval to "create a best-in-class lab.")

今天,Theranos正在进行的测试s with traditional machines, with some outsourced to outside labs -- for which it is suffering financial losses, according to theJournal. As for these claims, Buchanan told雷竞技手机版that the company isn't losing any money and is instead experiencing a record-breaking volume of tests in its labs and traffic in its stores.

"IfThe Wall Street Journalactually understood the laboratory industry a little bit better, they would know that it's very common practice for labs to send out certain tests to reference labs," she said.

Related:Safeway Seeks to Dissolve Secret $350 Million Deal With Beleaguered Blood Startup Theranos

Geoff Weiss

Former Staff Writer

Geoff Weiss is a former staff writer at Entrepreneur.com.

Related Topics

Business News

This Man Won a $22 Million Lottery Jackpot, But He and His Wife Won't Tell Their Kids — Here's Why

An anonymous caller named "John" shared his story on a recent episode of "The Ramsey Show."

Business News

Millionaires Are Now the Norm for American Households, According to Latest Federal Reserve Survey

The average net worth of homeowners stood at $1.53 million in 2022.

Business News

This Indulgent Retirement Trend Is Popular Among Young Professionals — But Financial Planners Are Providing a Dose of Reality

Gen Z is spending more on non-essential purchases like travel and entertainment.

Business News

Off-Duty Pilot Charged With 83 Counts of Attempted Murder After Trying to Shut Down Plane Engine Mid-Flight

The Alaska Airlines flight was headed to San Francisco from Everett, Washington, before it made an emergency landing in Portland, Oregon.

Marketing

This Is the Unconventional Marketing Tactic Small Businesses Need to Try

If you haven't tried this marketing strategy, your business is missing out on gaining maximum exposure, causing word-of-mouth hype and showing your audience your ingenuity and creativity. Find out what it's all about and how to incorporate it into your business.

Science & Technology

Most Effective Ways to Enhance Your Business with AI

Enhancing your business with AI and technology won't happen overnight, but it can happen with effort and time.