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Tuesday, April 7, 2020

GenMark Q1 revenue up big on COVID-19 boost; shares up 29% after hours

Citing a (most likely rare) positive impact from COVID-19, GenMark Diagnostics (NASDAQ:GNMK) sees Q1 revenue of ~$38.7M, up about 80% from a year ago and 46% above consensus of $26.5M.
About 80% of gross ePlex placements (net of 54 in the quarter) were from customers interested in COVID-19 testing. SARS-CoV-2 consumables accounted for ~2% of total ePlex revenue.
2020 revenue guidance increased to $112M – 122M from $100M – 110M.
Management will provide another update during its earnings call next month.
Shares up 29% after hours.
https://seekingalpha.com/news/3559147-genmark-q1-revenue-up-big-on-covidminus-19-boost-shares-up-29-after-hours

FDA extends action date for Roche’s risdiplam for spinal muscular atrophy

Citing the submission of additional data that it considered a major amendment, the FDA has extended the action date for its review of Roche (OTCQX:RHHBY) unit Genentech’s marketing application seeking approval for resdiplam for the treatment of spinal muscular atrophy.
The new action date is August 24 (from May 24).
Roche in-licensed global rights to the survival motor neuron-2 (SMN2) splicing modifier from PTC Therapeutics (NASDAQ:PTCT) in November 2011.
SMA-related tickers: Biogen (NASDAQ:BIIB), Ionis Pharmaceuticals (NASDAQ:IONS), Scholar Rock Holding (NASDAQ:SRRK), Novartis (NYSE:NVS)
https://seekingalpha.com/news/3559126-fda-extends-action-date-for-roches-risdiplam-for-spinal-muscular-atrophy

Partial unlock model for Covid-19, similar pandemic averts medical, economic disaster

Robert L Shuler

Posted April 06, 2020.
This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

Abstract

Data as of March 29, 2020 show that the flattening strategy for COVID-19 in the U.S. is working so well that a clean removal of social distancing (aka unlock) at any time in 2020 will produce a renewed catastrophe, overloading the healthcare system. Leaving the economy locked down for a long time is its own catastrophe. An SIR-type model with clear parameters suitable for public information, and both tracking and predictive capabilities which learns disease spread characteristics rapidly as policy changes, suggests that a solution to the problem is a partial unlock. Case load can be managed so as not to exceed critical resources such as ventilators, yet allow enough people to get sick that herd immunity develops and a full unlock can be achieved in as little as five weeks from beginning of implementation. The partial unlock could be for example 3 full working days per week. Given that not all areas or individuals will respond, and travel and public gatherings are still unlikely, the partial unlock might be 5 full working days per week. The model can be regionalized easily, and by expediting the resolution of the pandemic in the U.S. medical equipment and volunteers, many of them with already acquired immunity, can be made available to other countries.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

No external funding used in this research.

Author Declarations

All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.
Yes
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
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https://www.medrxiv.org/content/10.1101/2020.03.30.20048082v1

COVID-19 patient data registry to aid in care, adverse cardiovascular outcomes

As physicians, scientists and researchers worldwide struggle to understand the coronavirus (COVID-19) pandemic, the American Heart Association is developing a novel registry to aggregate data and aid research on the disease, treatment protocols and risk factors tied to adverse cardiovascular outcomes.
COVID-19 is associated with significant morbidity and mortality, with strong evidence for adverse cardiovascular outcomes.[1],[2] Moreover, patients with existing cardiovascular disease or CVD risk factors may be at higher risk for serious complications from COVID-19, including death.
The Association’s new, free COVID-19 CVD registry powered by its Get With The Guidelines® (GWTG) hospital quality improvement program, will be available to more than 2,400 hospitals currently participating in a GWTG module starting in May. In addition, aggregate data will be available to researchers through the Association’s Institute for Precision Cardiovascular Medicine.
”Having sufficient data is the first step to understanding the impact of COVID-19 on cardiovascular health,“ said John Warner, M.D., FAHA, chair of the quality oversight committee and  past volunteer president of the American Heart Association and executive vice president for Health System Affairs at the University of Texas Southwestern Health System in Dallas, Texas. “As a trusted resource for data and research, with an entry point in more than 2,400 U.S. hospitals, the American Heart Association is uniquely positioned to gather data quickly and accurately.”
Several studies have reported COVID-19 patients presenting with or developing heart failure, cardiogenic shock, stroke and lethal arrhythmias secondary to the disease. [3], [4] However, these studies have consistently been limited by the lack of a structured collection of data raising concerns about indication bias for most laboratory testing. Further, several of these studies are single-center descriptive assessments, limiting their generalizability.
In response, the American Heart Association is creating the multicenter registry to collect biomarkers, clinical data and cardiovascular outcomes in COVID-19 patients. The registry will focus on granular data collection from centers that routinely test biomarkers in COVID-19 patients.
To participate in the registry, contact qualityresearch@heart.org.
Additional resources and guidance for health care professionals on COVID-19 can be found here.
Get With The Guidelines (GWTG) is a hospital-based quality improvement program from the American Heart Association with tools and resources to increase adherence to the latest research-based guidelines.  The premise of the GWTG programs is when medical professionals apply the most up-to-date evidence-based treatment guidelines, patient outcomes improved.
https://newsroom.heart.org/news/new-covid-19-patient-data-registry-will-provide-insights-to-care-and-adverse-cardiovascular-outcomes
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Carmel, IN goes with proactive Covid-19 testing

While a proactive COVID-19 testing strategy is out-of-reach for much of the U.S., one large town in Indiana is hoping to show the public health benefits of screening for the disease early and often.
Last week, the city of Carmel, Indiana — just north of Indianapolis, with about 100,000 residents — started weekly screening all of its first responders and some city employees, as well as staff and residents of its nursing homes.
Mayor James Brainard said he hopes to next expand the program to all city employees and their dependents, and eventually to all city residents.
“We’re doing this to slow the spread. Ideally, the U.S. would have been able to do this weeks ago,” Brainard told MedPage Today. “We’ll find out who has it, quarantine them, and test their contacts, so that our hospitals and medical personnel do not become overwhelmed.”
As of Monday afternoon, 315 workers had been tested; the city has thus far sidelined four police officers who’ve been infected.
Angela Caliendo, MD, PhD, of Brown University in Rhode Island, said during an Infectious Diseases Society of America press briefing on Tuesday morning, that early testing could work in certain parts of the country.
“There are areas of the country that have not been hit yet, so we might be able to impact the epidemiology of this infection or their curve more effectively than we have in places like New York, Louisiana, and Detroit,” Caliendo said during the briefing. “If we have adequate testing, we could consider areas of the country that can implement a strategy of more broad testing than those hit early. The testing done in South Korea was very important in controlling their outbreak.”
Carmel entrepreneur Zak Khan, who grew up in the city and has a history of philanthropy there, pitched Brainard the idea of proactive testing, which was sanctioned by local medical experts, Brainard said. Khan owns a network of surgery centers, many of which have been temporarily closed due to elective surgery cancellations. He also owns a laboratory, Aria Diagnostics, which purchased a COVID-19 PCR testing unit from Thermo Fisher. That lab has set up drive-through testing for the program.
Khan’s lab charges about $150 per test, covered by Carmel’s self-insured health policy. Brainard anticipates a total cost of $500,000 to $600,000 for the first phase of the project. Ultimately, he’d like to test all 700 city employees, and eventually their total network of 1,800, which includes dependents, and eventually screen the entire city.
Khan said one challenge has been procuring test kits; none were available from the company’s regular supply chains, so he had to assemble his own kit and get FDA approval.
“It forces labs like us to be more entrepreneurial in putting it together,” Khan told MedPage Today.
He now buys sterile swabs and viral transport media separately. Since the typical Amies solution that’s used isn’t available, he’s found other types of viral transport media that can be substituted. While Amies is better for a full pathogen panel, there’s less concern about that since testing is now “laser-focused on COVID,” he said.
Reagents for the Thermo Fisher test have also been a challenge, one that he says may be a bigger roadblock than test kits, though his team is actively seeking out supply, he said.
While the machine can yield results within four hours, the volume of testing and the need to confirm positives extends that time; Khan tells customers to expect a result within 48 hours. He also partners with Indiana University Health which has access to rapid testing if needed.
For instance, if a firefighter is potentially exposed, he can be told quickly whether or not he has to quarantine. Quarantine costs the city because it requires paying time-and-a-half to another employee to cover that shift. If a test quickly comes back negative, Khan said, that firefighter can continue his shift.
Khan said his lab is working with another town in Indiana, and with a home health agency in Texas, on early testing and hopes to expand to others as well.
“We can beat this thing back,” Khan said. “If testing starts with first responders, then moves to healthcare providers, and then the rest of the community, Mayor Brainard’s vision will make Carmel’s line flat.”
Beth Rupp, MD, of Indiana University Health, who isn’t involved in the Carmel testing project, said it could help prevent spread of disease, but cautioned that Carmel’s situation is unique.
“If they have the resources to do that, I think it’s a really interesting idea,” she said, noting that Carmel is a wealthier city than many in Indiana. “A lot of people don’t have the resources to be able to carry that out.”
Rupp added that the “whole testing situation has been such a frustration to all of us in healthcare. I would love it if more testing were available for everyone everywhere.”
Khan expressed similar frustration that the current strategy in the U.S. “is based on a scarcity of tests. I want to make it based on, how do we flatten the curve? Basing it on not having availability of kits is an awful way of practicing medicine.”
https://www.medpagetoday.com/infectiousdisease/covid19/85834

Walgreens to open 15 COVID-19 testing sites in 7 states

Walgreens is opening 15 COVID-19 test sites in seven states across the country, the retail pharmacy chain said April 7.
The company said it will open sites in Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas and that it chose the states based on hot spot markets with escalating COVID-19 cases.
The sites will be in Walgreens parking lots, and pharmacists will oversee self-administration of the test. The company will use Abbott’s new COVID-19 test, which delivers results in five to 13 minutes.
Walgreens said it expects to be able to test up to 3,000 people per day, and the sites are expected to be up and running this week.
The tests will be free for people who meet CDC criteria for testing.
Read the full news release here.
https://www.beckershospitalreview.com/pharmacy/walgreens-to-open-15-covid-19-testing-sites-in-7-states.html

Mount Sinai reworks stroke platform to monitor COVID-19 patients remotely

New York City-based Mount Sinai Health System has adapted its stroke platform to remotely monitor COVID-19 patients, according to FOX News.
The Precision Recovery Platform has been designed for COVID-19 patients with symptoms not severe enough for hospitalization. Patients simply text “Precision Recovery” to 332-213-9130. A physician will then chat with the patient via video. Patients go on to download an app where they input their symptoms.
If physician notices concerning data about a patient, they can video chat with them or send an emergency medical team to evaluate the patient.
Assistant professor of neurosurgery at the Icahn School of Medicine at Mount Sinai Christopher Kellner, MD, co-developed the platform with David Putrino, MD.
“With remote monitoring of COVID-19, we can save hospital resources for the patients who need them most, but also quickly triage patients if and when they begin to show more severe symptoms while they are being monitored at home,” said Dr. Kellner, according to FOX News.
https://www.beckershospitalreview.com/healthcare-information-technology/mount-sinai-reworks-stroke-platform-to-monitor-covid-19-patients-remotely.html