Home Covid test funded by feds is too costly, complex

 For months, U.S. public health experts have called on the federal government to approve and fund cheap and fast at-home Covid-19 tests, to help bring the spread of infection under control. But when the Biden administration this week announced a $231.8 million deal to ramp up production of the first fully at-home test, the experts’ response was, to say the least, unenthusiastic. One dismissed it as “a spit in the ocean.”

It’s not that home testing with a 15-minute turnaround time isn’t a good idea, they said, it’s just that the rollout of this initial kit is too little and too late, and the test too expensive and complicated, to help extinguish the raging pandemic fire. A number of experts called on the Biden administration to subsidize the home test for consumers, and said the Food and Drug Administration needs to do more to make such tests widely available.

The first fully over-the-counter Covid test, a rapid antigen test produced by the Australian company Ellume, was granted an emergency use authorization in December. On Monday the administration said it would provide funding to build a factory in the U.S. that will eventually make millions of tests every month, but will take time to scale up.

“Making easier tests available to every American is a high priority with obvious benefits,” Andy Slavitt, White House senior adviser for Covid-19 response, said in a news conference where the deal was announced.

A year after the virus reached the United States, Covid testing remains hard to come by for many Americans, with tests restricted to doctor’s offices and other settings staffed by health workers. For many, the wait for results takes days, which is too slow to catch active, contagious infections, especially in asymptomatic people who may have been exposed to someone with an infection.

It’s an ongoing debacle fueled, critics say, by the Trump administration’s failure beginning early last year to develop and implement a national testing strategy. While the government spent billions to develop, buy, and distribute the most promising vaccines for free, testing was largely turned over to the private sector, which developed hundreds of different tests, many of them put into use without government vetting.

Even with mass vaccine rollouts, easy, accessible testing, along with mask use, will continue to be key components in curbing the spread of infection, said Atul Gawande, a surgeon, professor at the Harvard T.H. Chan School of Public Health, and former Covid-19 adviser to the Biden transition team. While he said the Ellume deal is a good step, technology and price barriers mean it’s not enough.

Gawande said the new administration has committed to a national testing strategy, which is important. Now the challenge is getting tests out to the public and communicating the importance of regular testing.

“We come back to again and again and again, the most powerful tool in the public health bag is communications,” said Gawande. “When we have had inconsistent communications from the top, a lack of commitment to widespread testing, even [President Trump] discouraging testing, it’s no surprise we are where we are.”

This week’s news is unlikely to change much, at least right away. The Ellume deal will ship 100,000 test kits to U.S. households per month from February to July, and eventually scale up production to 19 million tests per month.

In January, roughly 1.8 million to 2 million Covid tests were performed every day in the United States. The testing landscape is a mix of PCR tests, which have high accuracy rates but often take longer to generate results, and rapid antigen tests that have proven less accurate but give quick answers. Public health experts say that too much of the testing is reactive — used to help diagnose individuals who have possible symptoms or might have been exposed to the virus — instead of being deployed broadly to prevent spread and protect the general public. That’s where the call for cheap home testing comes in.

Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, has been among the loudest voices calling for federal funding and distribution of cheap, rapid, paper-strip antigen tests as a means to control the pandemic. In an ideal world, Mina said, every American would be able to test for Covid twice a week at home, with supplies paid for and distributed by the federal government.

Mina and others said they have concerns about the equity of the Ellume test. It is priced at $30, far too expensive for most Americans to conduct frequent, regular screening at home. And the test is linked to a smartphone app that requires some tech savvy and steps that Mina and others said add difficulty and confusion for most potential users. The test kit transmits results to users via the app, and conveys data to local public health agencies to enable tracking case counts and contacts.

“It’s not going to be an effective tool to really stop spread,” said Mina. “I look at this decision as more of a putting the cards on the table a little bit,” signaling that the administration is “willing to support rapid testing and home testing.”

Mina said widespread home testing would help get the spread of the virus under control. Even assuming a fraction of results are inaccurate, he said, frequent, free testing will catch undetected infections and help people make informed choices about their behavior. Ellume submitted data to the FDA describing the test as 95% accurate. In its approval, the agency cautioned that, as with all antigen tests, the test may give a small percentage of false-positive readings when patients are actually uninfected, or false-negative results when they actually have Covid. It warned that for patients without symptoms, positive results should be confirmed by further testing and that negative results don’t preclude an infection.

Eric Topol, chair of innovative medicine at Scripps Research, said the administration’s deal with Ellume will make “zero” difference and without the government subsidizing the cost of tests, it will do nothing to resolve the inequality of the testing landscape.

“It’s a waste of money. It’s throwing money away,” he said.

The Ellume test is a good test, he added, but it’s not what Americans need right now, which is free, very basic, easy-to-use home testing. He called the number of tests Ellume will provide “a spit in the ocean.”

Ellume said in a statement that its home test “is a critical part of the U.S. COVID-19 response because it’s the only rapid test currently approved for asymptomatic use, and it’s approved for use in ages 2+.”

Other tests have been given emergency FDA approval, but LabCorp’s Pixel and Abbott’s BinaxNOW home antigen tests, both of which are ramping up production, still require telemedicine consults. Mina said adding tech and doctor involvement further slows the process in what should be easy, cheap, accessible testing for all Americans. Critics say the FDA should move quickly to grant emergency authorization for cheap, rapid paper-strip tests.

Gawande was critical of the agency’s approach to regulating home antigen tests, saying it should consider approving lower-sensitivity tests with faster turnaround times to encourage production of cheap, easy tests — even though they might miss some infections.

“When the FDA wants to encourage certain kinds of testing capabilities, it’s been able to do that,” he said. “Right now, it’s still in the individual diagnostic approach.”

A senior FDA official said home tests will play an important role in the pandemic response. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told STAT in an interview that the agency sees a bigger role for home tests going forward, but it’s up to companies to develop them and apply for regulatory approval.

There are trade-offs between test performance and speed when comparing the rapid home tests to PCR tests done under medical supervision, Shuren said, noting that the FDA has set somewhat lower accuracy thresholds for the rapid tests. Home testing “will play an increasingly more important role,” he added. “In part, that will come down to production.”

This story is part of a project funded by the NIHCM Foundation. The foundation played no role in the reporting, editing, or presentation of this work.

https://www.statnews.com/2021/02/05/a-waste-of-money-the-home-covid-19-test-funded-by-the-biden-administration-is-too-costly-and-complex-critics-say/

 As the Food and Drug Administration moves closer to a decision about whether to approve a promising new Alzheimer’s treatment, the collaboration between scientists, regulators, and business leaders that produced this encouraging drug has come under fire as a “black eye” for the FDA that “dangerously compromised” its objectivity. This unfortunate charge misconstrues the drug development process and the indispensable partnerships that are needed to deliver new treatments.

The drug in question, aducanumab, takes aim at Alzheimer’s disease, the sixth leading cause of death in the U.S. and the only disease in the top 10 that has no cure and no treatment to slow its devastating impact. About 5.7 million Americans already live with Alzheimer’s, a figure projected to triple by 2050. Managing the disease cost the U.S. $305 billion in 2020, and is estimated to rise to $1.1 trillion per year by 2050.

We find it strange to see the criticism of a collaborative approach on this Alzheimer’s treatment when the FDA’s rapid approvals of the first Covid-19 vaccines were widely hailed as a model of collaboration among scientists, regulators, and business leaders to advance vital public health goals and save lives.

Last summer, hope for people with Alzheimer’s appeared to be on the horizon when the FDA accepted for review a new drug for the disease. Aducanumab, an experimental treatment made by Biogen, was tested in two randomized, double-blind clinical trials — the gold standard in drug testing. This research, done under guidance and oversight from the FDA, produced promising results, including the potential to alter the course of Alzheimer’s, which slowly deprives individuals of their memories and ability to perform daily tasks.

In the first trial, aducanumab slowed the disease’s progression among people with early Alzheimer’s and helped them better maintain cognitive function and independence.

A second late-stage trial, however, did not produce the same results. Researchers determined that the differences were largely due to a lower dose and shorter periods of treatment in the second trial. In that trial, however, it’s important to note that participants who received “consistent exposure to high doses of aducanumab” experienced the same positive benefits as patients in the first trial.

Both studies, plus an earlier study with aducanumab, showed evidence of beneficial changes in the brain associated with treatment.

Given the lack of effective Alzheimer’s treatments, the FDA granted aducanumab priority review status, a designation reserved for therapies addressing high, unmet health needs.

In November 2020, the FDA convened an advisory committee meeting of external panel members to review the data. (A recording of the webcast can be viewed here.) It was similar to the committee that green-lighted the Pfizer/BioNTech and Moderna vaccines for Covid-19. In a briefing for the committee, the FDA noted the “urgent and unmet medical need for effective [Alzheimer’s] treatments” and suggested that the divergent trial results “do not detract from the persuasiveness” of the positive results in the first clinical trial, which the FDA found to be compelling.

This is how the drug approval process is supposed to work. Regulators and scientists work together to build an understanding of how to attack a disease, perform supervised clinical trials to test the treatment, carefully evaluate the trial results, and (hopefully) speed innovations that can have a meaningful impact.

The advisory committee was not convinced of aducanumab’s effectiveness and did not support approving the drug.

And then the collaborative process for reviewing the drug’s clinical trial results came under attack. Public Citizen claims that what it called this “unprecedented” cooperation “undermines public confidence” in the FDA — without a shred of evidence that the relationship between the FDA and Biogen was in any way improper.

As the public record shows, collaboration between Biogen and the FDA began more than five years ago, “prior to and during the development of aducanumab” — and has included communications on trial design and planned analyses to more recent post-trial discussions. This partnership was not only appropriate but is expected by the FDA as defined in its recommended best practices for communication.

FDA guidance makes clear that the agency will engage with new drug application sponsors in “thousands of communications” throughout the development process to share information and provide critical advice. According to the FDA, sponsors and the agency “ideally” work collaboratively to achieve a shared goal of providing safe, effective, high-quality drugs to the American public through greater efficiency of the drug development process.

Public Citizen suggests that FDA approval of aducanumab would give “false hope” to millions of Alzheimer’s patients and “impede development” of other therapies. But the organization has it backwards.

As we have seen happen in the realm of cancer therapies, achieving breakthrough treatments is an incremental process rather than a single scientific breakthrough. An initial treatment for cancer with a 30% response rate is not a “cure.” But approving a first drug stimulates progress toward new ones — and combinations of therapies — that have gotten us to 60%, 70%, and now, for some types of cancer, close to 100% therapeutic responses. Blocking approval of a new drug until near perfection has been achieved stymies innovation and progress.

The FDA’s mission is to protect and promote public health. Failing to approve the first effective Alzheimer’s treatments — and opening the door to incremental innovations to defeat this terrible disease — would be the true “black eye” for the agency.

George Vradenburg is chairman and co-founder of USAgainstAlzheimer’s. Biogen is among the thousands of individuals, institutions, and companies that support the organization. Jeffrey Cummings is a neurologist, director of the Chambers-Grundy Center for Transformative Neuroscience, and research professor in the Department of Brain Health, all at the University of Nevada Las Vegas. He reports having acted as a consultant for Biogen, as well as for many other pharmaceutical and biotech companies.

https://www.statnews.com/2021/02/08/alzheimers-drug-development-collaboration-fda-industry/

S. Africa to roll out AstraZeneca vax in steps to assess effectiveness

 South Africa will roll out the AstraZeneca vaccine in a "stepped manner" to assess its effectiveness in preventing severe illness, Professor Salim Abdool Karim, the co-chair of South Africa’s Ministerial Advisory Committee on COVID-19, said on Monday.

Karim said South Africa would pause the rollout while determining how to roll it out, and could vaccinate 100,000 people with the shot to see how well it worked on preventing hospitalisations and deaths.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-South-Africa-to-roll-out-AstraZeneca-vaccine-in-steps-to-assess-effectiveness-32388101/

Italian DNA-based COVID-19 vaccine candidate could start trials in March

  Italy’s second COVID-19 vaccine candidate, COVID-eVax, is likely to start trials in early March after it was approved by the national drug regulator last week, one of the biotech firms leading the project said on Monday.

COVID-eVax was designed by Rome-based Takis and developed with Italian peer Rottapharm Biotech. It is based on a DNA fragment, unlike other COVID-19 vaccines already approved by the European medicines regulator EMA, which are based on mRNA or on adenoviral vectors.

“We expect to start the first week of March, complete phase 1 in July and phase 2 in October,” Lucio Rovati, chairman and scientific director of Rottapharm told Reuters.

“Then we expect to have finished Phase 3 in spring 2022,” he said.

Italy’s drug regulator AIFA on Feb. 3 authorised clinical trials of COVID-eVax, which will be carried out in three Italian hospitals, in Naples, Rome and Monza.

Italy’s other COVID-19 vaccine candidate - developed by Italian biotech firm ReiThera with Germany’s Leukocare and Belgium’s Univercells - is already in phase 2 clinical trials and is based on an adenoviral vector, the same technology used by AstraZeneca and Johnson & Johnson.

The development of COVID-eVax took off in February 2020 when Takis launched a crowdfunding initiative, but raised just 53,000 euros ($63,923.30). In June, Rottapharm joined in, providing funds and looking for new investors.

None have been secured so far but Rovati said the companies were in talks to get more funding.

“We are in regular dialogue with the Italian government on one hand and with the European investment bank (EIB) on the other,” he said.

COVID-eVax is based on a DNA fragment injected into the muscle that promotes the production of a portion of the virus’ spike protein, stimulating an immune reaction.

“DNA is a cheap and stable molecule and does not need a cold chain. Most importantly, its flexibility allows it to be easily adapted against new virus variants,” Takis CEO Luigi Aurisicchio said in the company’s statement on Feb. 3.

However, DNA is also a larger molecule than RNA, and to get it into muscle cells it is necessary to use electroporation, a mini electric jolt that is injected with a ‘gun’ rather than a syringe.

“This is why we are collaborating with another Italian company, IGEA, which manufactures electroporators. So I don’t think there will be any supply problems,” Rovati said.

https://www.reuters.com/article/us-health-coronavirus-italy-vaccine/italian-dna-based-covid-19-vaccine-candidate-could-start-clinical-trials-in-march-developer-idUSKBN2A81SP

AstraZeneca, Oxford race to update COVID vax as study flags weak action on variant

 It didn’t take long before a morale boost for AstraZeneca’s COVID-19 vaccine was overshadowed by disappointment over its waned protection against a newly emerged coronavirus variant.

A new study has found AZ’s COVID-19 shot offered “minimal protection” against mild to moderate disease caused by the B.1.351 variant, which was first identified in South Africa, the University of Oxford, the original developer of the vaccine, said Sunday.

The finding has prompted the pair to update their vaccine, dubbed AZD1222, to target variants of the coronavirus with mutations similar to B.1.351. In the meantime, South African authorities have halted rollout of the vaccine as they try to figure out the best way forward.

“Efforts are underway to develop a new generation of vaccines that will allow protection to be redirected to emerging variants as booster jabs, if it turns out that it is necessary to do so,” Sarah Gilbert, Ph.D., of the University of Oxford said in a statement. A modified version could be ready by fall, she said, according to the BBC.

The bad news came on the heels of another Oxford study showing AZD1222, also known as ChAdOx1 nCoV-19, remains effective against the B.1.1.7 variant, which was first spotted in the U.K. Both B.1.1.7 and B.1.351 are more contagious than the original SARS-CoV-2 virus, but it appears that B.1.351 is the tougher one to tackle for existing vaccines and antibody drugs.

In the current study, scientists analyzed data from 2,000 volunteers who got the AZ shot in a phase 1/2 clinical trial in South Africa. They found the vaccine was only 22% effective at protecting against mild to moderate COVID-19, according to multiple media reports. The vaccine’s neutralization titers against B.1.351 were “substantially reduced” when compared with those for the original version of the virus, according to Oxford. The full data haven’t been released.

Because the trial participants are mainly young and fit adults who were on average 31 years old, the study wasn’t able to assess protection against moderate to severe disease, hospitalization or death.

In a statement, an AstraZeneca spokesperson said the company believes AZD1222 can protect against severe disease caused by B.1.351, “as neutralizing antibody activity is equivalent to that seen with other COVID-19 vaccines that have demonstrated activity against more severe disease.” The spokesperson pointed out that no severe disease or hospitalization was recorded in the early-phase trial.

AZD1222 isn’t the only COVID-19 vaccine to have lost some of its power against the B.1.351 variant. Previously, Moderna reported a sixfold reduction in neutralizing titers for mRNA-1273 against B.1.351. While the Massachusetts biotech maintained that the shot was still able to protect people, it has started making a booster shot targeting the variant.

As is the case with AZD1222, Johnson & Johnson’s COVID-19 vaccine candidate also wraps a piece of the coronavirus’s DNA in an adenovirus vector. In its phase 3 trial, the J&J shot was found to be 72% effective at fending off moderate to severe disease in the U.S., whereas its protection fell to 57% in South Africa, where the B.1.351 variant is prevalent.

Novavax’s adjuvanted candidate NVX-CoV2373 also showed weaker efficacy in South Africa. In its phase 3 trial in the U.K., the protein-based vaccine demonstrated an efficacy of 89.3%. But in a phase 2b trial in South Africa, the number dropped to 60%, with 90% of confirmed infections attributed to B.1.351.

Amid rising concerns over new virus variants that could be resistant to existing vaccines, several companies have started to design booster shots. Besides Moderna and AZ, Pfizer and partner BioNTech are also working on an updated version of its mRNA vaccine Comirnaty, and CureVac has teamed with GlaxoSmithKline—with help from the U.K. government—to develop multivalent vaccines or potential booster shots to CureVac’s phase 3 candidate.

https://www.fiercepharma.com/pharma/astrazeneca-oxford-race-to-update-covid-19-vaccine-as-study-flags-weak-action-against

Nautilus Biotech to List on Nasdaq via Merger with Arya Sciences Acquisition

 Nautilus Biotechnology, Inc. ("Nautilus Biotechnology" or “Nautilus”), a company pioneering a single-molecule protein analysis platform for quantifying the human proteome, and Arya Sciences Acquisition Corp III (Nasdaq: ARYA) (“Arya III”), a special purpose acquisition company or SPAC, sponsored by Perceptive Advisors, today announced they have entered into a definitive business combination agreement. Upon closing of the transaction, Arya III will redomicile as a Delaware corporation, be renamed Nautilus Biotechnology, Inc. and its common stock is expected to be listed on Nasdaq under the ticker symbol “NAUT” (the “Combined Company”).

In addition to the approximately $150 million held in Arya III’s trust account (assuming no redemptions are effected), a group of premier healthcare investors has committed to participate in the transaction through a common stock PIPE of approximately $200 million at $10 per share. Investors in the PIPE include lead investor Perceptive Advisors, an affiliate of Arya III’s sponsor, as well as RA Capital Management, Ally Bridge Group, Bain Capital Life Sciences, Franklin Templeton Investments, OrbiMed, Alyeska Investment Group, L.P., Casdin Capital and existing Nautilus Biotechnology shareholders including Andreessen Horowitz, Madrona Venture Group, and Vulcan Capital.

The Combined Company is expected to receive proceeds of approximately $350 million at the closing of the transaction (assuming no redemptions are effected) and will continue to operate under the Nautilus management team, led by founder and Chief Executive Officer, Sujal Patel, and founder and Chief Scientist, Parag Mallick. The boards of directors of both Arya III and Nautilus have approved the proposed transaction. Completion of the transaction, which is expected in the second quarter of 2021, is subject to approval of Arya III’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

Conference Call and Webcast Information

Conference Call Dial-in (Audio only):
Monday, February 8, 2021 at 8:00 AM ET
US Toll-Free Dial In: (855) 920-2730
US Local Dial In: +1 (469) 598-1899
Universal Int’l Dial In: +1 (913) 270-0999
Conference ID: 67993

A webcast of the conference call and associated presentation materials will also be available on Deal Roadshow:

Deal Roadshow Investor Login Details:
Monday, February 8, 2021 at 8:00 AM ET
URL: https://dealroadshow.com
Entry Code: NAUT2021
Direct Link: https://dealroadshow.com/e/NAUT2021

A replay of the call will be available today starting at 9:00 AM ET through the same Deal Roadshow link shown above.

https://www.businesswire.com/news/home/20210208005194/en/Next-Gen-Proteomics-Company-Nautilus-Biotechnology-to-List-on-Nasdaq-Through-Merger-with-Arya-Sciences-Acquisition-Corp-III

CRH Medical to be Acquired by Well Health

 CRH Medical Corporation (TSX: CRH) (NYSE: CRHM) ("CRH" or the "Company") today announced that it has signed a definitive agreement (the "Acquisition Agreement") with Well Health Technologies Corp. ("WELL Health" or "WELL"), pursuant to which WELL Health will acquire all of the issued and outstanding shares of CRH for US$4.00 per share, representing an aggregate purchase price of approximately US$292.7 million (the "Acquisition") and a transaction value of approximately US$369.2 million inclusive of credit facility. The purchase price represents a premium of approximately 83% to the closing price of the Company's shares on February 5, 2021 (the last trading day prior to announcement of the Acquisition), and a premium of approximately 80% to the 30-day volume-weighted average price of the Company's shares as of that date. WELL Health has today announced that it has received binding commitments in connection with a concurrent non-brokered private placement financing that is expected to close on or before February 15, 2021, however the Acquisition is not subject to any financing condition.

"This transaction is the logical next step for CRH as WELL adds CRH to its portfolio of healthcare related businesses" commented Tushar Ramani, CEO of the Company. "Since joining the Company, my mandate has been to drive the value of CRH through organic and acquisitive growth, and the results of those efforts are reflected in the premium being paid to shareholders in this transaction."

Details of the Transaction

The Acquisition, which is to be carried out by way of a court-approved plan of arrangement under the Business Corporations Act (British Columbia), will require the approval of: (i) two-thirds of the votes cast by shareholders of the Company; and (ii) two-thirds of the votes cast by shareholders, holders of stock options and holders of restricted share units, voting together as single class. The Company's directors and officers, holding an aggregate of approximately 2.1% of the outstanding common shares of the Company, have each entered into voting support agreements to vote their shares in favour of the Acquisition. Completion of the Acquisition will also be subject to court and regulatory approvals and clearances, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the Acquisition is expected to be completed during Q2 2021.

The Acquisition Agreement contains certain customary provisions, including covenants in respect of non-solicitation of alternative acquisition proposals, a right to match any superior proposals for WELL Health and a termination fee of $10 million payable to WELL in certain circumstances. The Acquisition Agreement also provides for a reverse termination fee of $10 million payable to CRH in the event of certain breaches of a representation, warranty or covenant by WELL Health.

Further details with respect to the Acquisition will be included in the proxy statement and information circular to be mailed to security holders in connection with the meeting that will be held to consider the Acquisition. A copy of the Acquisition Agreement will be filed on the Company's SEDAR profile and with the U.S. Securities and Exchange Commission and will be available for viewing at www.sedar.com and www.sec.gov.

Citi is serving as CRH's lead financial advisor in connection with the transaction, with Canaccord Genuity also providing financial advice. The Company's legal advisors in connection with the transaction are Blake, Cassels & Graydon, LLP and Skadden, Arps, Slate, Meagher & Flom LLP.

About CRH Medical Corporation:

CRH Medical Corporation is a North American company focused on providing gastroenterologists throughout the United States with innovative services and products for the treatment of gastrointestinal diseases. In 2014, CRH became a full-service gastroenterology anesthesia company that provides anesthesia services for patients undergoing endoscopic procedures in ambulatory surgical centers. To date, CRH has completed 31 anesthesia acquisitions, and now serves 69 ambulatory surgical centers in 13 states. In addition, CRH owns the CRH O'Regan System, a single-use, disposable, hemorrhoid banding technology that is safe and highly effective in treating all grades of hemorrhoids. CRH distributes the O'Regan System, treatment protocols, operational and marketing expertise as a complete, turnkey package directly to gastroenterology practices, creating meaningful relationships with the gastroenterologists it serves. CRH's O'Regan System is currently used in all 48 lower US states.

https://finance.yahoo.com/news/crh-medical-announces-agreement-acquired-113000233.html