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Wednesday, September 2, 2020

CM Life Sciences Prices Upsized $385 Million IPO

CM Life Sciences, Inc. (the “Company”) announced today that it priced its initial public offering of 38,500,000 units at $10.00 per unit. The units will be listed on The Nasdaq Capital Market (“Nasdaq”) and trade under the ticker symbol “CMLFU” beginning September 2, 2020. Each unit consists of one share of Class A common stock and one-third of one redeemable warrant, with each whole warrant exercisable to purchase one share of Class A common stock at a price of $11.50 per share. After the securities comprising the units begin separate trading, the shares of Class A common stock and warrants are expected to be listed on Nasdaq under the symbols “CMLF” and “CMLFW,” respectively. The Company expects the offering to be consummated on September 4, 2020.

The Company, sponsored by affiliates of Casdin Capital, LLC and Corvex Management LP, is led by Chief Executive Officer Eli Casdin and Chairman Keith Meister. The Company is a blank check company formed for the purpose of effecting a business combination. The Company intends to focus its search for business combination targets in three separate areas of the life sciences industry that are often fragmented – life sciences tools, synthetic biology and diagnostics.

Jefferies LLC is serving as the sole book runner for the offering. The Company has granted the underwriter a 45-day option to purchase up to an additional 5,775,000 units at the initial public offering price to cover over-allotments, if any.

The offering is being made only by means of a prospectus. When available, copies of the prospectus may be obtained from: Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10002, by telephone: 877-821-7388 or by email: Prospectus_Department@Jefferies.com.


Will the new 15-minute COVID-19 test solve US testing problems?

On Aug. 26, the Food and Drug Administration granted an Emergency Use Authorization to a new rapid antigen test for COVID-19 called the BinaxNOW test.

Testing is one of the most powerful tools available to fight the spread of COVID-19. The new test is inexpensive, rapid and easy to use. It will massively scale up access to testing, but hurdles remain in achieving widespread, frequent COVID-19 testing.

What type of test is BinaxNOW?

The credit-card-sized test is an antigen test that detects a specific viral protein from SARS-CoV-2. It costs US$5 and doesn’t require a lab or a machine for processing.

Performing the test is simple. A health care worker or technician would use a swab to collect a sample from less than 1 inch inside the nostril. They would then combine the sample with a few drops of chemicals inside the test card. Within 15 minutes, the test strip would show a positive or negative result. The test is also paired with an app that produces a digital code that can be scanned to show proof of a recent negative COVID-19 test.

What does the Emergency Use Authorization allow for?

The BinaxNOW test is currently only authorized for patients who have had COVID-19 symptoms for seven days or less, which is when virus levels in the body are likely to be high. It must be prescribed by a physician and performed by a trained technician or other health care worker.

The PCR test for COVID-19 is currently widely used and considered the gold standard, but requires patient samples to be sent to a lab and can take days to provide results. The new antigen test is designed to be a cheap and quick alternative to PCR testing for diagnostic purposes in a medical setting. It would add critical capacity to an overstretched testing system.

The emergency use authorization provides preliminary authorization for doctors to prescribe the antigen test while the full FDA approval process is ongoing. The authorization could be revoked if the test is not as accurate or reliable as expected.

How accurate is this test?

Abbott, the health technology company that produces the test, reports that when patients had symptoms the test was in agreement with PCR testing for 97.1% for COVID-19 positive cases and 98.5% for COVID-19 negative cases. This is high enough for diagnostic settings where accuracy is critical.

However, the true accuracy could be lower because the performance testing group was only 102 people and the accuracy hasn’t been validated by the FDA as part of the full approval process. There will inevitably be some false negatives and false positives with the BinaxNOW test since accuracy isn’t 100%, but the FDA will monitor the data to make sure the test meets the reported accuracy.

Can this test be used for widespread screening?

The BinaxNOW test is cheap, rapid, able to be mass-produced and easy to use outside a lab. This makes it a promising candidate for widespread screening. However, the test is currently only authorized for people with COVID-19 symptoms.

This is an obstacle because an estimated 40% of all COVID-19 cases are asymptomatic and these people likely don’t know that they’re contagious. To maximize the effectiveness of any COVID-19 screening program, it is important to test people whether they have symptoms or not.

Health care providers are able to prescribe the BinaxNOW test for asymptomatic patients for off-label use, but health officials don’t yet know how accurate the test is when performed on asymptomatic people.

Is this test a game-changer?

The massive expansion of testing access made possible by the BinaxNOW test will almost surely outweigh the downsides of a small number of inaccurate results. Abbott plans to manufacture 50 million tests per month starting in October. This will quickly exceed the 76 million COVID-19 tests the U.S. has performed over the last six months.

Widespread, frequent testing is effective at slowing the spread of the coronavirus. The new testing capacity made possible by the authorization of this rapid antigen test represents a major advance in bringing the pandemic under control.


Diabetes as a consequence of COVID-19 September 2, 2020

The SARS-CoV-2 coronavirus, which causes the coronavirus disease COVID-19, can penetrate many different body cells. This has been shown in multiple research papers published in recent weeks. Thus, not only can the function of the respiratory tract and the lungs be severely disrupted, but also numerous other organs. The SARS-CoV-2 virus can also penetrate the so-called beta cells in the pancreas and damage them, as a research team involving the Cluster of Excellence “Precision Medicine in Chronic Inflammation” has now observed for the first time.

These cells are responsible for producing the insulin required for a healthy metabolism. A SARS-CoV-2 infection can apparently disrupt this function, which as a result leads to diabetes. The observations were published by Professor Matthias Laudes, Schleswig-Holstein Excellence-Chair for endocrinology, diabetology and clinical nutritional medicine at Kiel University and his research team of the Clinic of Internal Medicine I at the University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, together with researchers from Munich and Dresden, in the renowned scientific journal Nature Metabolism.

The publication is an initial description of insulin deficiency diabetes after a COVID-19 illness, based on an observed case. “A 19-year-old patient came to us in the clinic with newly-developed severe diabetes with insulin deficiency. It could be shown that he apparently had experienced a SARS-CoV-2 infection a few weeks before,” reported Laudes, who is also a member at the steering committee of the Cluster of Excellence “Precision Medicine in Chronic Inflammation” (PMI). “Such an insulin deficiency diabetes, i.e. type 1 diabetes, is usually triggered by an autoimmune response, in which the immune system incorrectly identifies the beta cells in the pancreas as foreign and attacks them. But this autoimmune response was not present in this patient. We assume that here, the SARS-CoV-2 virus itself attacked the beta cells.”

This also fits with the fact that the beta cells possess a crucial receptor: the ACE2 receptor. The SARS-CoV-2 virus can specifically bind with this receptor. The receptor is also used by the virus as an entry point into the other body cells which it attacks.

The lead author of the publication is the medical doctor and early career researcher Dr. Tim Hollstein, who only joined the department of Professor Laudes at the beginning of this year, after a research stay at the National Institute of Health (NIH) in the U.S. “I am delighted that Dr. Hollstein could make such an important observation as a young early career researcher. This newly-discovered metabolic disease demonstrates how important a detailed clinical and laboratory chemical characterization of COVID-19 can be for patients at a university endocrinological center,” said Laudes.

Under the leadership of cluster spokesperson Professor Stefan Schreiber, the UKSH is also conducting a long-term follow-up study into COVID-19 patients under the name “COVIDOM,” in which all persons reported as infected in Schleswig-Holstein will be invited to participate.

“This success of Professor Laudes and his team underlines the importance of accurate follow-up observation after COVID-19. We are certain that as a result of this disease, even more health-relevant metabolic problems can arise,” said PMI spokesperson Professor Stefan Schreiber, head of “COVIDOM” and director at the Department of Internal Medicine I at the UKSH, Campus Kiel.






More information: Tim Hollstein et al. Autoantibody-negative insulin-dependent diabetes mellitus after SARS-CoV-2 infection: a case report, Nature Metabolism (2020). DOI: 10.1038/s42255-020-00281-8


Retest for COVID-19 4+ weeks after symptoms first appear to curb infection risk

People who’ve had COVID-19 should be swab tested again 4 or more weeks after symptoms first appear to minimise the risk of onward infection, suggests a large population based study in one of Italy’s former coronavirus hotspots, and published in the online journal BMJ Open.

This is because SARS-CoV-2, the virus responsible for COVID-19 infection, takes an average of 30 days to clear from the body after the first positive test result and an average of 36 days after symptoms first appear, the study findings show. And it’s not yet known how infectious a person may be in the recovery phase, warn the researchers.

What’s more, the findings indicate that the rate of false negative test results—whereby people are falsely reassured they no longer have active (shedding) virus in their bodies—is relatively high (1 in 5) in early convalescence, so putting them at risk of unwittingly passing on the infection.

An accurate assessment of how long it takes the body to clear SARS-CoV-2 is key to curbing the risk of onward infection and minimising the enforced isolation period for patients who no longer have symptoms, say the researchers.

To explore this further they tracked the progress of 4538 residents of the Reggio Emilia province in the Emilia-Romagna region of Italy, all of whom tested positive for the virus between February 26 and April 22 this year.

Italy was the first Western country to be badly affected by COVID-19. By mid-April 2020, it ranked third in the world for the number of cases and related deaths. Emilia-Romagna was one of the country’s three coronavirus regional hotspots.

Because of missing data, 4480 people were included in the preliminary analysis; 1259 achieved viral clearance, determined by at least one negative swab test after the initial positive test, and 428 died. The average time to viral clearance was 31 days from the first positive swab test.

The researchers then looked at the speed of viral clearance in 1162 people out of the original 4480 for whom sufficient time had passed since the first positive swab (at least 30 days). Each surviving patient was retested an average of three times: around 15 days after the first positive swab; 14 days after the second; and 9 days after the third.

Viral clearance was detected in 704 (60.5%) and confirmed in just under 79% of those tested again after the first negative swab (436/554), suggesting a rate of 1 false negative out of every 5 negative test results.

The average time to viral clearance in this group was 30 days after the first positive swab and 36 days after the start of symptoms, but took slightly longer depending on age and severity of the infection.

Based on their findings, the researchers suggest that retesting 14 days after a positive swab will, in most cases produce the same result, and that there’s still a relatively high rate of false negative results when retesting up to 3 weeks later.

Their data point to a lengthy period of active viral shedding, say the researchers, who caution: “To avoid generating secondary cases, either the isolation period should be longer [30 days from the start of symptoms] or at least one follow-up test should be done before ceasing isolation.”

They point out that previously published experimental research indicates that during convalescence a person is probably not infectious, even if they test positive, prompting the WHO to recommend a period of up to 13 days of isolation for those with symptoms and 10 days for those without.

“But the evidence on the risk of transmission during the convalescent phase characterised by a positive [swab test] is weak, and current serological data have not provided any additional insight. Furthermore, current epidemiological evidence of transmission has been influenced by how quarantine has been managed thus far,” caution the researchers.




More information: Temporal profile and determinants of viral shedding and of viral clearance confirmation on nasopharyngeal swabs from SARS-CoV-2-positive subjects: a population-based prospective cohort study in Reggio Emilia, Italy, BMJ Open (2020). DOI: 10.1136/bmjopen-2020-040380


CryoLife announces acquisition of aortic repair device developer

CryoLife (NYSE:CRY) acquires Florida-based Ascyrus Medical for up to $200M, including $60M cash and $20M shares of CryoLife’s common stock in upfront payment.

Ascyrus is a privately-held developer of the Ascyrus Medical Dissection Stent (AMDS), the world’s first aortic arch remodeling device used for the treatment of acute Type A aortic dissections. 

The acquisition will result in CryoLife’s high single-digit revenue growth beginning in 2021 and non-GAAP earnings growth over the next five years.

“We believe the addition of the AMDS to our product offerings will make a meaningful contribution to our future growth as it gives us immediate access to the combined $100+ million EU and Canadian markets and has the potential to expand our worldwide addressable market by approximately $540 million,” says CEO Pat Mackin.


Global Consensus Supports Wider Use of Cochlear Implants

“Awareness of cochlear implantation among primary and hearing health care clinicians is inadequate, leading to under identification of eligible candidates. Clearer referral and cochlear implantation candidacy pathways would help increase access to cochlear implants.”

That is the first consensus statement in a new international document on the use of unilateral cochlear implants among adults with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss.

To arrive at the consensus statements, which was published online August 27 in JAMA Otolaryngology – Head and Neck Surgery, a panel of 31 experts conducted a systematic literature review, considered the findings in light of their own clinical expertise, and then spent 9 months reaching agreement using a Delphi consensus method. They also considered input from cochlear implant users and patient advocacy groups.

The resulting 20 consensus statements focus on unilateral cochlear implants and address the clinical effectiveness of cochlear implants, best practices from diagnosis to surgery, factors linked to post-implant outcomes, and associations of hearing loss with depression, cognition, and dementia, as well as cost.

“The recommendations for surgeons, audiology experts and health care providers are crystal clear,” panel chair Craig Buchman, MD, head of the Department of Otolaryngology at Washington University School of Medicine in St. Louis, Missouri, stated in a news release.

The experts hope their international consensus article will improve awareness and help reverse global underutilization of the devices. The authors note that previous research suggests that only 1 in 20 people who could benefit from a cochlear implant have one.

Funding from Advanced Bionics, Cochlear Ltd, MED-EL, and Oticon Medical supported the Delphi process and medical writing. These funding organizations did not contribute to the design, facilitation, or content of the Delphi consensus process.

JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. Full text


Almost 44,000 Child COVID-19 Cases in 1 Week

Child cases moved up to 9.5% of the cumulative COVID-19 population as the United States added almost 44,000 pediatric cases for the week ending Aug. 27, according to a report from the American Academy of Pediatrics (AAP) and the Children’s Hospital Association (CHA).


The new cases bring the cumulative number of infected children to over 476,000, and that figure represents 9.5% of the over 5 million COVID-19 cases reported among all ages, the AAP and the CHA said in their weekly report. The cumulative number of children covers 49 states (New York is not reporting age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

From lowest to highest, the states occupying opposite ends of the cumulative proportion spectrum are New Jersey at 3.4% — New York City was lower with a 3.2% figure but is not a state — and Wyoming at 18.3%, the report showed.

Children represent more than 15% of all reported COVID-19 cases in five other states: Tennessee (17.1%), North Dakota (16.0%), Alaska (15.9%), New Mexico (15.7%), and Minnesota (15.1%). The states just above New Jersey are Florida (5.8%), Connecticut (5.9%), and Massachusetts (6.7%). Texas has a rate of 5.6% but has reported age for only 8% of confirmed cases, the AAP and CHA noted.

Children make up a much lower share of COVID-19 hospitalizations — 1.7% of the cumulative number for all ages — although that figure has been slowly rising over the course of the pandemic: it was 1.2% on July 9 and 0.9% on May 8. Arizona (4.1%) is the highest of the 22 states reporting age for hospitalizations, and Hawaii (0.6%) is the lowest, based on the AAP/CHA data.

Mortality figures for children continue to be even lower. Nationwide, 0.07% of all COVID-19 deaths occurred in children, and 19 of the 43 states reporting age distributions have had no deaths yet. Pediatric deaths totaled 101 as of Aug. 27, the two groups reported.