Walmart to Begin Nationwide In-Store Sales of Biomerica Colorectal Screening Test

 

• Over 4,600 Walmart Stores to sell the EZ Detect™ product
• Simple 2 minute at-home test detects early warning sign of colorectal cancer

Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced that Walmart has begun in-store sales and rollout of the Company’s EZ Detect™ colorectal disease screening test within the nationwide Walmart retail system. Biomerica has shipped the EZ Detect product to Walmart distribution centers in the US and product is projected to be on the shelf in over 4,600 Walmart Stores nationwide over the next two weeks. The in-store retail placement follows Biomerica’s previous announcement in early October, that Walmart had begun sales of EZ Detect™ product for online purchase through Walmart.com (https://www.walmart.com/ip/EZ-Detect-Colon-Disease-Test-Kit/577079744). As part of its ongoing sales strategy, the Company has hired an internal digital and social media team to increase its presence on all major social communication platforms (Instagram: https://bit.ly/3j5FYDB; Facebook: https://bit.ly/3aBJBfN;   Twitter: https://bit.ly/3BNROJW), and to promote awareness for its at-home testing products. In addition, Biomerica is in negotiations with several large partners for distribution of the EZ Detect™ product in Asia, Europe and the Middle East.

The EZ Detect™ colon disease screening test is the simplest at-home test to detect occult (hidden) blood in a person’s stool, which can be an early warning sign of colorectal diseases, including colon and rectal cancers. The test does not require handling of stool or dietary restrictions.  A person simply places an EZ Detect™ test pad into the toilet after a bowel movement.  A change in the pad’s color to blue/green, which would appear within two minutes, indicates the presence of blood in the stool.  The pad is then simply flushed down the toilet.

“We’re excited to broaden our relationship with Walmart to now have EZ Detect™ available in the store at retail locations across the country, in addition to their online sales channel,” commented Zack Irani, CEO of Biomerica. “Walmart is the largest retailer in the world. Each week, approximately 220 million customers and members visit stores and clubs in 24 countries and on eCommerce websites. Early detection is a key factor to beating colorectal cancer. The inclusion of EZ Detect™ on Walmart shelves is a significant development in making our easy and innovative in-home tests available to more patients.”

Colorectal cancer (“CRC”) is the second most common cause of cancer death in the United States. In 2020, an estimated 147,950 Americans were projected to be diagnosed with CRC, and an estimated 53,200 were projected to die from the disease, including 17,930 cases and 3,640 deaths in individuals under the age of 50 [1].

In a study performed by Johns Hopkins University, EZ Detect™ was preferred 10:1 by patients over another fecal occult blood test. Published studies have also indicated that the best colorectal screening test is “the one that gets done.” [2] Other colorectal screening tests require handling of the stool and delivering or mailing the stool sample to a lab for processing. Handling of the stool results in a high percentage of these competing tests never being performed by patients[3]. EZ Detect™ does not require handling of the stool, is simple to perform and provides results at home in just two minutes.

For further information about the EZ Detect Product, please visit ezdetect.com

https://www.globenewswire.com/news-release/2021/10/19/2316295/0/en/Walmart-to-Begin-Nationwide-In-Store-Sales-of-Biomerica-s-EZ-Detect-Colorectal-Screening-Test.html

Atea’s antiviral pill fails to clear Covid-19, forcing a re-think

 Atea Pharmaceuticals said Tuesday that its antiviral pill for Covid-19 failed to combat the virus in a mid-stage trial, leading the company to delay its pivotal study by a year.

The disappointing news follows a far more hopeful October update from Merck, whose similar antiviral reduced the chances that patients newly diagnosed with Covid-19 would be hospitalized by about 50% in a Phase 3 study.

There is a desperate need for treatments for early Covid that can be taken as pills. Current treatments, such as remdesivir and monoclonal antibodies, are generally given intravenously or as injections, and are difficult to distribute to large numbers of people. The hope is that pills to treat Covid could be given widely in order to prevent infected people from progressing to severe disease, hospitalization, or death.

Atea, partnered with global drug maker Roche, said its drug, AT-527, failed to beat placebo at reducing the amount of measurable virus in patients with mild or moderate Covid-19, missing the primary endpoint of a 100-patient trial.

As a result, Atea and Roche are rethinking their Phase 3 trial. That study, designed to enroll up to 1,400 patients, has a primary endpoint of reducing the time it takes patients to recover from Covid-19 and secondary goals including preventing hospitalization. In light of the Phase 2 results, Atea and Roche are now considering whether to change the primary endpoint and target population. Data from that study, once expected this year, are now slated for the second half of 2022, Atea said.

“We remain committed to our goal of developing and delivering AT-527 as an oral antiviral that will address treatment needs as Covid-19 continues to evolve,” Atea CEO Jean-Pierre Sommadossi said in a statement.

Atea’s drug works similarly to Merck’s and was widely expected to succeed in clinical development. The problem might have been trial design. While Merck deliberately excluded patients who had been vaccinated for Covid-19, Atea did not, which might have skewed the results, according to the company. Merck also recruited only patients who had at least one risk factor for severe Covid-19, such as obesity or heart disease, while Atea required only a positive test and mild symptoms.

The news is a bitter disappointment for Atea, which has spent the past 18 months touting the potential of AT-527, developed as a treatment for hepatitis C, to change the course of the Covid-19 pandemic. The company, which commanded a market value of about $3.4 billion as of Monday, fell 70% in premarket trading on Tuesday.

Merck, partnered with Ridgeback Biotherapeutics, is seeking an emergency use authorization for its Covid-19 antiviral and will make its case to a panel of Food and Drug Administration advisers on Nov. 30. Results for another potential oral Covid-19 treatment, from Pfizer, are expected by the end of the year.

https://www.statnews.com/2021/10/19/ateas-antiviral-pill-fails-to-clear-covid-19-forcing-a-re-think/

J&J Covid vaccine added $502 million to third-quarter sales

 Johnson & Johnson said it sold $502 million of its Covid-19 vaccine in the third quarter, in its earnings report Tuesday that beat Wall Street’s profit expectations.

Here’s how J&J did compared with what Wall Street expected, according to average estimates compiled by Refinitiv:

• Adjusted EPS: $2.60 per share vs $2.35 expected.
• Revenue: $23.34 billion vs $23.72 billion expected.

J&J increased its full-year earnings guidance to between $9.77 per share and $9.82 per share, from its previous estimates of $9.60 to $9.70 per share. It expects sales to range from $94.1 billion to $94.6 billion, up from previous guidance of $93.8 billion to $94.6 billion.

At the same time, the company maintained its Covid vaccine sales outlook for the year at $2.5 billion.

Shares of J&J jumped more than 1% in premarket trading.

The company’s better-than-expected profit was bolstered by higher sales in its consumer health, pharmaceutical and medical devices units.

Its consumer unit, which makes products such as Neutrogena face wash and Listerine, generated $3.7 billion in revenue, up 5.3% from a year earlier.

J&J’s pharmaceutical business, which developed the single-shot Covid vaccine, generated $12.9 billion in revenue, a 13.8% year-over-year increase.

Its medical device unit generated $6.6 billion, an 8% increase. That unit was hit hard last year as the pandemic forced hospitals to postpone elective surgeries and Americans stayed home.

J&J Chief Financial Officer Joseph Wolk told CNBC the revenue miss is due to the Covid vaccine and medical device unit.

The company has maintained its vaccine sales outlook for the year, and it plans to ship as much as it can through the rest of the year, he said on “Squawk Box.” J&J also experienced “fluctuations in elective procedures with the delta variant.”

J&J’s report came under a shadow of criticism about how it handled the opioid crisis and the development of a comparatively less-effective Covid vaccine under outgoing CEO Alex Gorsky.

In a press release, Gorsky said the financial results “demonstrate solid performance across Johnson & Johnson, driven by robust above-market results in Pharmaceuticals, ongoing recovery in Medical Devices, and strong growth in Consumer Health.”

Earlier this month, the company asked the Food and Drug Administration to authorize a booster dose of its single-shot Covid vaccine.

An influential FDA advisory committee on Friday said the agency should authorize boosters of J&J’s vaccine to the more than 15 million Americans who have already received the initial dose. A final decision by the FDA is expected within days.

https://www.cnbc.com/2021/10/19/covid-and-johnson-johnson-jnj-earnings-q3-2021.html

Discovery of new role for brain’s immune cells may have Alzheimer's implications

 University of Virginia School of Medicine researchers have revealed a vital but previously unknown role for immune cells that protect the brain from disease and injury: The cells, known as microglia, also help regulate blood flow and maintain the brain's critical blood vessels.

In addition to revealing a new aspect of human biology, the findings may prove important in cognitive decline, dementia and stroke, among other conditions linked to diseases of the brain's small vessels, the researchers say.

"Precise blood vessel function is critical to accommodate the extreme energy demands of the brain for normal brain function," said UVA's Ukpong B. Eyo, PhD, of UVA's Department of Neuroscience, the UVA Brain Institute and UVA's Center for Brain Immunology and Glia (BIG). "These findings suggest previously unknown roles for these brain cells in the proper maintenance of blood delivery to the brain and provide novel opportunities to intervene in contexts where blood perfusion to the brain is impaired."

The Role of Microglia

Scientists have known that microglia play many important roles in the brain. For example, the cells police the natural blood-brain barrier that protects the organ from harmful germs in the bloodstream. Microglia also facilitate the formation of the brain's complex network of blood vessels during development. And they are known to be important in many diseases. In Alzheimer's disease, for example, recent work suggests that the loss of the immune cells is thought to increase harmful plaque buildup in the brain.

Scientists have been unsure, however, what role microglia play in maintaining blood vessels in a normal, healthy brain. The new research from Eyo and his colleagues reveals that the cells are critical support staff, tending the vessels and even regulating blood flow.

The UVA researchers identified microglia associating with the brain's capillaries, determined what the immune cells do there and revealed what controls those interactions. Among the cells' important responsibilities is helping to regulate the diameter of the capillaries and possibly restricting or increasing blood flow as needed.

"Researchers have been studying these cells in the living brain for over two decades but this is the first time we are able to get an idea of these mechanisms of microglia-blood vessel interaction," said Eyo, a top expert on microglia. "It's an exciting time to be the first to make these findings here at UVA."

The researchers believe their new findings could have significant implications for diseases that affect the small vessels of the brain. These conditions are thought to contribute to strokes, Alzheimer's, loss of balance and mental decline, among other serious health problems.

"We are currently expanding this research into an Alzheimer's disease context in rodents to investigate whether the novel phenomenon is altered in mouse models of the disease and determine whether we could target the mechanisms we uncovered to improve known deficits in blood flow in such a mouse model of Alzheimer's," Eyo said. "Our hope is that these findings in the lab could translate into new therapies in the clinic that would improve outcomes for patients."

Story Source:

Materials provided by University of Virginia Health System. Note: Content may be edited for style and length.

---

Journal Reference:

1. Kanchan Bisht, Kenneth A. Okojie, Kaushik Sharma, Dennis H. Lentferink, Yu-Yo Sun, Hong-Ru Chen, Joseph O. Uweru, Saipranusha Amancherla, Zainab Calcuttawala, Antony Brayan Campos-Salazar, Bruce Corliss, Lara Jabbour, Jordan Benderoth, Bria Friestad, William A. Mills, Brant E. Isakson, Marie-Ève Tremblay, Chia-Yi Kuan, Ukpong B. Eyo. Capillary-associated microglia regulate vascular structure and function through PANX1-P2RY12 coupling in mice. Nature Communications, 2021; 12 (1) DOI: 10.1038/s41467-021-25590-8

https://www.sciencedaily.com/releases/2021/10/211015094806.htm

UK announces 10 billion pounds of green deals at investment summit

 

Britain said it had attracted nearly 10 billion pounds ($13.72 billion) from global investors to fund its green regeneration agenda, as it hosted an investment summit involving 200 of the world's top financiers and executives.

The summit marks post-Brexit Britain's biggest push to woo investors, even leveraging the soft power of drinks with Queen at her castle, as it seeks cash and partners to get ahead in the international race for a competitive edge in green technology.

"We are rolling out the green carpet for investors," said trade department minister Gerry Grimstone ahead of the summit opening.

The British government announced private investment deals worth 9.7 billion pounds, including 6 billion pounds in offshore wind from Iberdrola, as well as in net zero carbon warehouses and decarbonisation technology for the waste industry.

Prime Minister Boris Johnson will open the summit in central London on Tuesday, speaking to financiers such as JPMorgan Chase & Co Chief Executive Jamie Dimon, Blackrock CEO Larry Fink and bosses from GlaxoSmithKline and Darktrace.

France has held a similar investment summit in recent years, but Britain believes it has a trump card over its neighbour: after the summit, attendees will travel to Windsor Castle for a reception attended by the Queen and other senior royals.

The event comes at a time when Britain's green credentials are in the spotlight, two weeks before it hosts the U.N. COP26 climate summit, where Johnson will try to broker a complex international deal to stall rising global temperatures.

The government last year issued a plan setting out how it wanted to prioritise green technology and climate goals in Britain's economic recovery from the COVID-19 pandemic.

That gambit is central to Johnson's political agenda too, having been elected in 2019 on a pledge to reinvigorate post-industrial parts of the country and create higher-skilled, better-paid jobs.

The new investments are on top of 5.85 billion pounds the government said last week had been agreed since Johnson launched his plan in November.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GlaxoSmithKline-UK-announces-10-billion-pounds-of-green-deals-at-investment-summit-36712021/

SEC says GameStop meme stock frenzy fueled by ‘investor sentiment’

 Following its highly anticipated review into the events surrounding the "meme stock" trading saga in January, the Securities and Exchange Commission determined that the "bullish sentiments" of individual investors on social media platforms like Reddit were primarily responsible for the unprecedented surge in GameStop's share price. 

Not nefarious actions. 

"The extreme volatility in meme stocks in January 2021 tested the capacity and resiliency of our securities markets in a way that few could have anticipated," the SEC wrote. "At the same time, the trading in meme stocks during this time highlighted an important feature of United States securities markets in the 21st century: broad participation."

According to the SEC, the number of investor accounts trading GameStop on a given day rose to almost 900,000 in late January from less than 10,000 at the beginning of the month. Shares of GameStop soared approximately 2,700% between its intraday low on Jan. 8 and its intraday high on Jan. 28. 

While the agency acknowledged that short sellers closing out their positions on GameStop contributed to the video game retailer's stock price increase at the time, they argued that such buying was "a small fraction of overall buy volume, and that GME share prices continued to be high after the direct effects of covering short positions would have waned."

"Whether driven by a desire to squeeze short sellers and thus to profit from the resultant rise in price, or by belief in the fundamentals of GameStop, it was the positive sentiment, not the buying-to-cover, that sustained the weeks-long price appreciation of GameStop stock." 

-  Securities and Exchange Commission

"Whether driven by a desire to squeeze short-sellers and thus to profit from the resultant rise in price, or by belief in the fundamentals of GameStop, it was the positive sentiment, not the buying-to-cover, that sustained the weeks-long price appreciation of GameStop stock," the agency added. 

The agency also poured cold water on a popular theory that brokerages like Robinhood Markets were pressured by hedge funds and wholesalers to restrict trading on GameStop and other meme stocks.

"In their customer account agreements, some broker-dealers reserve the right to decline customer orders or cancel trades without prior notice," the SEC said. "Such actions could be taken, for example, for legal, compliance, or risk management reasons."

In addition, the SEC found no evidence of a gamma squeeze, where market makers purchase a stock to hedge the risk associated with writing call options on that stock, or "naked" short selling, where hedge funds sell without arranging to borrow shares. 

Rather than offering specific policy recommendations, the SEC said the events provide "an opportunity to reflect" on market structure issues, such as digital engagement's impact on retail investor behavior, payment for order flow, trading in dark pools and through wholesalers, and short selling.

The agency believes that shortening the amount of time it takes for brokers to clear equity trades could help mitigate market risk during heightened volatility going forward. The SEC also said consideration should be given to whether "game-like features and celebratory animations that are likely intended to create positive feedback from trading lead investors to trade more than they would otherwise." 

In addition, the agency argued improved reporting on short sales could help the agency better monitor the relationship between shorting and stock price dynamics. 

https://www.foxbusiness.com/markets/sec-gamestop-investors-meme-stocks

COVID Vaccine Response Varies With MS Treatment Type

 New evidence continues to emerge about how multiple sclerosis (MS) disease-modifying treatments (DMTs) may affect COVID-19 vaccine response.

In a late-breaking presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, Joseph Sabatino, Jr., MD, PhD, of the University of California San Francisco (UCSF), showed that two of six DMT types had a significant effect on vaccine-induced immunity to SARS-CoV-2.

Antibody responses were quantitatively normal in MS patients on glatiramer acetate (Copaxone), dimethyl fumarate (Tecfidera), and natalizumab (Tysabri), but were reduced in patients either on sphingosine-1-phosphate (S1P) receptor modulators or on anti-CD20 therapies like ocrelizumab (Ocrevus) and rituximab (Rituxan), Sabatino said.

MS patients on S1P receptor modulators had impaired vaccine-specific CD4 T cell responses, while patients on anti-CD20 therapies had intact vaccine-induced CD4 and CD8 T cell responses. Detectable CD19 B cells and shorter duration of treatment were associated with improved antibody responses in anti-CD20 patients.

The findings also were posted on the preprint server medRxiv. "As far as I'm aware, our study was the first to report that cumulative duration of anti-CD20 therapy is associated with reduced vaccine-induced antibody responses," Sabatino told MedPage Today.

"This research is important in helping us navigate treatment and vaccine decisions real-time with our patients," noted co-author Riley Bove, MD, also of UCSF. "We are working very hard to understand the effects of newer agents such as ofatumumab (Kesimpta), which were approved during the pandemic."

In a scientific session at ECTRIMS, Mihir Kakara, MD, of the University of Pennsylvania in Philadelphia, also presented research about immune responses in MS patients on anti-CD20 DMTs. The findings, recently published in Nature Medicine, showed anti-CD20 drugs significantly reduced spike-specific and receptor-binding domain-specific antibody and memory B cell responses in most patients after either Pfizer-BioNTech (Comirnaty) or Moderna mRNA vaccination. The effect was ameliorated with longer durations from the last anti-CD20 treatment.

All MS patients on anti-CD20 DMTs generated antigen-specific CD4 and CD8 T cell responses after vaccination, Kakara reported.

"Vaccinations -- mRNA vaccines in our case -- induce robust cellular responses despite attenuated antibody responses in B-cell depleted individuals, which means that if they are infected, they may be able to clear the virus well and possibly have reduced COVID-19 severity," Kakara told MedPage Today.

"But for better antibody responses, delaying B-cell depletion treatment as long and safely as possible from last treatment to administer vaccine and waiting for at least 4 weeks following vaccination for next B-cell depletion treatment is suggested," he added.

The findings are important and extend earlier work about COVID vaccine effectiveness in MS patients, noted John Corboy, MD, of the University of Colorado in Denver, who wasn't involved with either study.

"It's been shown that if you're infected with COVID while you're on an anti-CD20 drug, you may have a worse outcome," Corboy told MedPage Today. "So, a big question is whether vaccination will adequately protect you."

While studies involving laboratory markers of immunity are valuable, "they don't tell us what the actual clinical ramifications are," Corboy said.

Sabatino's study involved 80 participants: 13 healthy controls, nine MS patients on no treatment, five patients treated with glatiramer acetate, five with dimethyl fumarate, six with natalizumab, seven with any S1P receptor modulator, and 35 with an anti-CD20 drug, including 13 on rituximab and 22 on ocrelizumab. Baseline samples were collected an average of 7 days before SARS-CoV-2 vaccination. Post-vaccine samples were collected an average of 2 weeks after the second shot for mRNA COVID-19 vaccines or 4 weeks after the Johnson & Johnson adenoviral vaccine was administered.

In Kakara's study, 20 MS patients on anti-CD20 treatment and 10 healthy controls were assessed at the time of their first mRNA vaccine dose and 10-12 days later, then at the time of their second mRNA shot, 10-12 days after that, and 25-30 days after the dose. "It will be important to study how cell-based responses relate to protection, complications, and the risk of infecting others," Kakara said.

Disclosures

The study by Sabatino's group was supported by grants from the NIH and the Maisin Foundation. Sabatino reported no conflicts of interest.

The study by Kakara's group was supported by grants from the NIH and funding from the Allen Institute for Immunology, Chen Family Research Fund, National Multiple Sclerosis Society-American Brain Foundation Clinician Scientist Award, Parker Institute for Cancer Immunotherapy, Penn Center for Research on Coronavirus and Other Emerging Pathogens, University of Pennsylvania, and philanthropic gifts. Kakara reported no conflicts of interest.

Primary Source

European Committee for Treatment and Research in Multiple Sclerosis

Source Reference: Kakara M "SARS-CoV-2 mRNA vaccine responses in patients with MS on anti-CD20 therapy" ECTRIMS 2021.

Secondary Source

European Committee for Treatment and Research in Multiple Sclerosis

Source Reference: Sabatino JJ, et al "Impact of MS disease-modifying therapies on antibody and T cell responses following COVID-19 vaccination" ECTRIMS 2021.

Additional Source

Nature Medicine

Source Reference: Apostolidis SA, et al "Cellular and humoral immune responses following SARS-CoV-2 mRNA vaccination in patients with multiple sclerosis on anti-CD20 therapy" Nat Med 2021; DOI: 10.1038/s41591-021-01507-2.

Additional Source

medRxiv

Source Reference: Sabatino JJ, et al “Impact of multiple sclerosis disease-modifying therapies on SARS-CoV-2 vaccine-induced antibody and T cell immunity” medRxiv 2021; DOI: 10.1101/2021.09.10.21262933.

https://www.medpagetoday.com/meetingcoverage/ectrims/95110