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Friday, July 31, 2020

Quidel in line for NIH funding to support COVID-19 testing on Sofia platform

Quidel (QDEL +0.3%) has signed a letter contract with NIH related to the latter’s Rapid Acceleration of Diagnostics (RADx) initiative aimed at boosting U.S. testing capacity for SARS-CoV-2 leveraging new technologies.
The company expects to ink a definitive agreement with the agency by mid-September, gaining access to funding to support the expansion of testing capacity in San Diego for its tests for the coronavirus performed on its Sofia Fluorescence Immunoassay platform. Specifically, the monies would be earmarked to support the upgrade and addition of manufacturing lines that will increase capacity from 84M cassettes per year to more than 220M per year.
The capital would also support the outfitting of a larger distribution center for the company’s rapid diagnostic assays.

Fauci suggests protests spread COVID-19, but won’t ‘opine’ on limiting

Dr. Anthony Fauci told the House Select Committee on the Coronavirus Crisis that “crowds” further the spread of the coronavirus, but wouldn’t “opine” on whether the government should limit widespread protests as it has businesses and churches in a testy exchange Friday with Rep. Jim Jordan, R-Ohio.
The National Institute of Allergy and Infectious Diseases (NIAID) director appeared alongside Centers for Disease Control and Prevention Director (CDC) Dr. Robert Redfield and “testing czar” Admiral Brett Giroir, a Health and Human Services official and physician. The hearing was titled “The Urgent Need for a National Plan to Contain the Coronavirus.”
Jordan pushed Fauci on whether protests increased the spread of the virus, to which Fauci said that he can “make a general statement” that “crowding together particularly when you’re not wearing a mask contributed to the spread of the virus.” He later said any crowd, including protest crowds, would constitute a “risk” — and that indoor crowds are a bigger problem than outdoor ones.
But Jordan appeared to suggest Fauci was applying a double standard by holding back on stating that demonstrations should be curtailed for health reasons.
Jordan asked Fauci, “should we limit the protesting?” Fauci had Jordan clarify the question, to which Jordan responded “should government limit the protesting?”
Fauci said “I’m not in a position to determine what the government can do in a forceful way,” before Jordan interrupted: “You make all kinds of recommendations, you make comments on dating, on baseball, on everything you can imagine. I’m just asking, you just said, protesting increases the spread. I’m just asking you should we try to limit the protest?”
“I think I would leave that to people who have more of a position to do that,” Fauci responded. “I can tell you that…”

Utah students can go to school after exposure to COVID-19 – guidelines

Utah students will be allowed to go to school even if they’ve been directly exposed to COVID-19, according to new guidelines released Thursday by the state health department.
Under what officials are calling “a modified quarantine,” parents will be given the choice to keep children home or send them back to class after close contact with the contagious virus — which they can do as long as the student is not showing any symptoms and no one in the immediate household has tested positive. Teachers and staff, too, can continue to come to work with the same rules, especially in cases where there are no substitutes available.
“This will allow children to stay in the educational system and get the classroom setting that they need,” said Dr. Angela Dunn, the state’s epidemiologist, during a virtual news conference Thursday.
Dunn said the process is the same one that essential employees in Utah, such as medical professionals or grocery workers, have used during the outbreak. “And it has worked,” she added.
Schools should only shut down, the health department advises, after 15 individuals have tested positive in the same time frame (or 10% in schools with fewer than 100 people). And then, the closure should be for two weeks, the incubation period of the virus. For a single classroom to go online, there would need to be three people with COVID-19.
Otherwise, schools statewide are encouraged to operate in person under the governor’s orders for this fall.
“We’re not going to sit back in the corner and wring our hands and say, ‘We can’t do anything,’” Gov. Gary Herbert said Thursday.

Oscar Health unveils $0 Virtual Primary Care program, 2021 expansion plans

Oscar Health is planning to expand into 19 new markets and four new states in 2021, the insurer announced Thursday.
The expansion will bring the startup health plan’s geographic footprint to 19 states and 47 markets, pending regulatory approvals. It will bring Oscar’s individual and family plans to potential members in Arkansas, Oklahoma, Iowa and North Carolina, as well as to new markets in some of the states it already serves, such as Florida and Pennsylvania.
The announcement also marks the fourth straight year that Oscar has unveiled plans to expand.
Alongside the plans to further expand its reach, Oscar unveiled its new $0 Virtual Primary Care, which will offer a slew of digital and in-home services to its individual and family plan members in 10 markets, including Houston, Miami, New York City and Los Angeles, at no cost.

“With the launch of Oscar Primary Care, Oscar is making even more unprecedented, cost-effective plans available,” Oscar CEO Mario Schlosser said in a statement. “Americans consistently cite cost, quality and convenience as their biggest struggles with the healthcare system—our new offering solves for all of them.”
Members will have unlimited access to virtual visits with dedicated Oscar primary care providers for $0, as well as no cost for tier-one prescriptions, durable medical equipment, labs, diagnostic imaging and initial specialty care referrals from Oscar providers.
The primary care program will also offer vitals monitoring kits and in-home lab draws at no cost when ordered by Oscar primary care providers.
The Virutal Primary Care program is in addition to Oscar’s existing care teams that assist with navigation and $0 Virtual Urgent Care offerings.
Oscar also announced last month that its co-branded plans with Cigna will launch in Atlanta and in the San Francisco Bay Area and across Tennessee later this year, pending regulatory approvals.

AbbVie’s Humira powers profit beat as COVID-19 weighs on Botox sales

AbbVie Inc (ABBV.N) on Friday posted a quarterly adjusted profit above estimates as robust sales of its blockbuster arthritis treatment, Humira, helped cushion weak demand for its aesthetic drugs, including Botox, due to the COVID-19 pandemic.
The company bought Allergan for a hefty $63 billion in May, to gain control over its medical aesthetics business including lucrative wrinkle treatment Botox and reduce dependence on Humira ahead of its U.S. patent expiry in 2023.
The unit, however, suffered as Americans postponed non-emergency procedures during shelter-in-place restrictions to control the spread of the coronavirus.
Total Botox cosmetic comparable sales plunged 43.1% to $226 million and therapeutic sales fell 22.3% to $297 million in the second quarter ended June 30, on a comparable basis.
Mizuho analyst Vamil Divan said the aesthetics unit and Botox, however, are holding up better through COVID-19 than the brokerage had expected.
AbbVie said both the businesses are seeing a rapid recovery and are now performing near pre-COVID levels.
“At of the end of June, the vast majority of our aesthetics accounts have reopened in the United States, and we’re seeing considerable pent-up demand,” Chief Executive Officer Richard Gonzalez said on a post-earnings conference call.
The company also said it expects to see continued recovery in the second half of the year as its total business had already recovered to more than 90% of pre-COVID levels by the end of June.
AbbVie forecast a combined company 2020 adjusted earnings of $10.35 to $10.45 per share, representing a 11% annualized net accretion from the Allergan deal. The forecast includes the results of Allergan from May 8 through Dec. 31.
This is above consensus estimate of $10.35 per share, according to Divan.
Excluding items, AbbVie reported a quarterly profit of $2.34 per share, beating estimates of $2.19 per share, according to Refinitiv IBES data.

NIH investing $248.7 mln in seven companies to scale up COVID-19 testing

The National Institutes of Health (NIH) said on Friday it is investing $248.7 million in seven diagnostic companies with new testing technologies to increase their testing capacities and make millions of rapid COVID-19 tests per week available by fall.
The funding is part of NIH’s Rapid Acceleration of Diagnostics (RADx) initiative which was launched in April.
The U.S. health agency said three of the selected companies, Talis Biomedical, Quidel Corp and Mesa Biotech, offer point-of-care tests, while the remaining four — Ginkgo Bioworks, Helix OpCo LLC, Fluidigm Corp and Mammoth Biosciences Inc — offer lab-based tests.
Adequate diagnostic testing and faster processing are crucial in the United States, which leads the world in COVID-19 deaths. The country has reported nearly 152,384 deaths so far and at least 4.5 million coronavirus cases, according to a Reuters tally.
U.S. labs now run about 800,000 diagnostic tests daily, according to the COVID Tracking Project. But the United States needs 6 million to 10 million tests per day, by various estimates.
The range of new lab-based and point-of-care tests that the seven companies offer could significantly increase the number, type and availability of tests by millions per week as early as September 2020, the agency said.


Philips Denies Overcharging US Government for Ventilators

Koninklijke Philips NV said Friday that it hasn’t raised the prices of its ventilators in the U.S. to benefit from the coronavirus pandemic.
The Dutch medical-technology company said that it doesn’t recognize the conclusions of a report released on Friday by the U.S. House of Representatives Subcommittee on Economic and Consumer Policy.
The report claims that an order made in 2014 for more than 10,000 Trilogy ventilators by June 2019 was renegotiated earlier this year under new terms at almost five times the price of the previous contract.
The report also says that a second contact for 43,000 Trilogy EV300 ventilators was entered into on April 7 at $15,000 each.
“I would like to make clear that at no occasion, Philips has raised prices to benefit from the crisis situation,” the company’s Chief Executive Frans van Houten said.