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Amazon wins EUA to sell its COVID-19 test directly to consumers

Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test.

The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, according to an FDA letter.

STS Lab Holdco previously won EUA in March for the real-time PCR test without the direct-to-consumer sale option. The current indication includes those without symptoms or other reasons to suspect COVID-19 infection and is limited to authorized laboratories.

Authorization extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected in individual vials containing transport medium, the letter reads.

Test results from specimens collected with the Amazon COVID-19 test collection kit DTC can be deli…

Drug prescription volume growth climbed to 21% in late May

Photo by Alexandros Chatzidimos from Pexels

As the U.S. economy continues to stabilize in the wake of the COVID-19 pandemic, prescription volumes continue to rebound as well. The overall market growth for prescription drugs from May 21–28 hit 21% year over year, according to IQVIA data. The growth rate in the prior two weeks was 13%.

New prescription growth from May 21 to 28 increased 34% year over year while retail growth hit 23%. In general, pharmacy chains have seen a rapid upward trend in sales since December 2020, with growth stabilizing in May 2021.

While mail-order prescriptions have expanded during the pandemic, total mail-order prescriptions accounted for only 5.2% of the total prescription drug market in late May.

All of the 42 therapeutic areas that Truist Securities tracks grew from May 21 to 28.

A recently released analyst report from UBS’s Kevin Caliendo, however, noted tha…

Amazon company gains EUA for COVID test

Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for its real-time PCR test for COVID-19.

According to an FDA letter, dated March 25, the test is authorized for the detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individuals 18 or older, including those without symptoms or other reasons to suspect COVID-19 infection.

Samples can be collected with Amazon’s test kit either under the supervision of a healthcare provider or unsupervised at home, as well.

The authorization also extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected with the Amazon COVID-19 collection kit under the supervision of a healthcare provider.

Testing with the Amazon collection kit is limited to certified laboratories that can perform high complexity tests and are designated by STS Lab Holdco. The kit includes a nasal …

Could your smart speaker monitor your heart rate?

Lead author Anran Wang sits with the smart speaker prototype (white box in foreground) the team used for the study. (Image by Mark Stone, University of Washington)

Hey Alexa, how’s my heart rate?

Researchers at the University of Washington say they’ve devised a way to enable smart speakers to work as contact-free heart-rate monitors.

Their proof-of-concept uses algorithms that transform the smart speaker into a short-range active sonar system and measure heart rate and inter-beat intervals (R-R intervals) for both regular and irregular rhythms, according to a study published in Nature Communications Biology.

Get the full story on our sister site, Medical Design & Outsourcing.

MedTech 100 roundup: Another peak for the industry

Medtech has been on the rise in 2021 and the past week saw that trend continue, as the industry hit yet another all-time best mark.

MassDevice‘s MedTech 100 index reached 107.4 points on Jan. 20, topping the all-time best of 106.81 points set on Jan. 8. That mark represents a 16% jump from the pre-pandemic high of 92.32 set on Feb. 19, 2020, and a 72.9% overall leap from the lowest point of 62.13 set on March 23, 2020.

Here are some of the best-performing medtech stocks from 2020.

The high point could not be sustained, but the industry stayed strong, finishing at 106.4 to end the week on Jan. 22. Medtech’s finish to last week was enough to top the previous seven days, coming in 0.6% ahead of the 105.8-point mark set on Jan. 15.

While medtech saw slight growth from the previous week, one of the overall markets saw a larger jump, with the S&P 500 Index rising 1.9%. The Dow Jones Industrial Average fared identically to medtech, rising 0.6%.

Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

Get the full story at our sister site, Pharmaceutical Processing World.

Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

The letter congratulated Biden and Vice President Kamala Harris on their inauguration and said that its more than 800,000 U.S. employees — most of whom are classified as “essential workers” amid the pandemic — should receive the approved vaccines from Pfizer/BioNTech and Moderna as soon as possible.

“The essential employees working at Amazon fulfillment centers, AWS data centers and Whole Foods Market stores across the country who cannot work from home should receive the COVID-19 vaccine at the earliest appropriate time,” Amazon CEO, Worldwide Consumer, Dave Clark wrote.

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BREAKING: Amazon, Berkshire, JPMorgan joint healthcare venture is ending

Amazon (NSDQ:AMZN), Berkshire Hathaway and JPMorgan Chase announced today that they are ending their joint healthcare venture.

The venture, launched in 2018 and known as “Haven,” aimed to bring the companies’ scale and complementary expertise to a long-term project which initially focused on technology solutions to help provide their U.S. employees and families with “high-quality and transparent healthcare at a reasonable cost,” according to a press release at the time.

Following the announcement of the joint venture in January 2018, shares in major health insurers UnitedHealth and Anthem fell as investors pondered the potential disruption that the new venture might bring to the market. In the end, though, the three companies appear to be mostly moving on.

“In the past three years, Haven explored a wide range of healthcare solutions, as well as piloted new ways to make primary care easier to access, insurance benefits simpler to u…

3M sues seller of fake and damaged N95 respirators

3M (NYSE:MMM) announced that it filed a legal action in federal court alleging that a seller on Amazon inflated prices of fake, defective and damaged N95 masks.

N95 masks have been in high demand as the COVID-19 pandemic roars on. In April, the U.S. Defense Dept. awarded a $76 million contract to 3M to produce the respirators under the Defense Production Act (DPA) and the company announced two more DoD contracts last month.

The lawsuit alleges that Mao Yu and affiliated companies defrauded customers by charging the inflated prices for the fake and damaged respirators, falsely advertising as third-party sellers under the 3M brand. The company alleges that the defendants charged unsuspecting customers more than $350,000 when they responded to false listings claiming to be selling authentic N95 masks.

3M’s allegations state that the defendants charged prices that exceed as much as 20 times the list prices for 3M’s N95 respirators. Amazon learned…