Hologic Inc. HOLX, +1.33%
shares rose more than 2% in the extended session Monday after the maker
of medical devices said its fiscal third-quarter’s financial outlook
has improved, mainly because one of its units is seeing more revenue
related to COVID-19 tests. Its surgical business has started to recover
faster than the company expected, and its diagnostics business has
outperformed “significantly” thanks to “strong” sales of the company’s
COVID-19 tests, Hologic said. The company said it expects revenue from
the diagnostics business to grow between 20% and 25% in the quarter. Due
to ongoing uncertainty related to the pandemic, however, it would not
quantify longer-term financial effects. Hologic ended the regular
trading day up 1.3%.
https://www.marketwatch.com/story/hologics-financial-outlook-improves-thanks-to-coronavirus-tests-2020-06-08
Monday, June 8, 2020
Gripping Theory Offers Clue to Predicting Cognitive Decline
Low or asymmetrical handgrip strength may be an indicator of cognitive decline in seniors, new research suggests.
Investigators analyzed handgrip strength in over 17,000 adults aged 50 years and older and found that those with both asymmetry and weakness had a twofold increase risk of accelerated cognitive decline.
In particular, those with the greatest odds for lower cognitive functioning had considerably more strength in their nondominant than their dominant hand.
“Having weakness, as measured by maximal handgrip strength, and/or wide strength differences between hands, could be a clue for low cognitive functioning,” lead author Ryan McGrath, PhD, assistant professor in the Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, told Medscape Medical News.
“If a person has weakness and/or handgrip strength asymmetry, a more comprehensive cognitive evaluation may want to be considered — or even evaluations of other age-related health conditions such as frailty,” McGrath said.
The study was published online May 30 in the Journal of the American Geriatric Society.
Previous studies focusing on cognition indicate that imbalances in muscle strength “could be linked to the neural system deficits that drive low cognitive functioning.”
The researchers therefore “wanted to enhance handgrip strength protocols by also evaluating handgrip strength asymmetry because we are usually only interested in maximal handgrip strength,” said McGrath.
To investigate, the researchers analyzed a sample of 17,163 individuals (median age, 65 years [SD, 10.1 years]; 42.2% male; 68.1% non-Hispanic white; 17.7% non-Hispanic black), drawn from the 2006 to 2016 waves of the Health and Retirement Study, a longitudinal study that monitors a variety of factors in aging Americans.
Most participants rated their health as “very good” or “good” (31.2% and 31.8%, respectively).
The researchers assessed cognitive function at each wave of the study using the Telephone Interview for Cognitive Status with “lower” status defined as ≤ 11 for participants ages 50‐64 years and ≤ 10 for those aged ≥ 65 years.
Handgrip strength of both dominant and nondominant hands was measured using a handgrip dynamometer, with “weakness” defined as handgrip strength < 26 kg in men or < 16 kg in women.
Participants with handgrip strength > 10% stronger on either hand were considered as having “any [handgrip strength] asymmetry,” and participants with handgrip strength > 10% stronger on their dominant or nondominant hand were considered as having “dominant” or “nondominant” handgrip strength asymmetry, respectively.
Compared with participants with symmetric handgrip strength and no weakness, those with any handgrip strength asymmetry alone had 15% greater odds for lower cognitive functioning, participants with weakness alone had 64% greater odds for lower cognitive functioning, and those with both handgrip strength asymmetry and weakness had 95% greater odds for lower cognitive functioning.
The odds of lower cognitive function were even greater when examining
hand dominance specifically. Those with dominant handgrip strength
symmetry alone, nondominant handgrip strength asymmetry alone, weakness
alone, dominant handgrip strength asymmetry and weakness, and
nondominant handgrip strength asymmetry and weakness had 12%, 27%, 64%,
89%, and 110% greater odds for lower cognitive functioning,
respectively.
“The associations for low cognitive function [and handgrip asymmetry] were exacerbated when those with handgrip strength asymmetry also had weakness,” said McGrath.
“We recommend that measures of handgrip strength asymmetry be used alongside assessment of weakness to improve the prognostic value of handgrip dynamometers,” he added.
He noted that the “feasibility for completing handgrip strength measurements are high [and] opportunities for measuring handgrip strength at home are emerging.”
Fargo, who was not involved with the study, said that it is “important to note that handgrip strength is not a tool used to assess current or future cognitive function, and that this topic may be worth further investigation, since it is relatively simple to administer and measure.”
For example, “it could be a simple screening tool that could indicate
the need for a more comprehensive cognitive evaluation [but] we simply
don’t know at this point,” Fargo stated.
McGrath noted that some healthcare providers use measures of handgrip strength to primarily assess muscle function, “but overall the use of handgrip strength in routine geriatric health assessments is generally absent.”
He encourages healthcare providers “to use measure of handgrip strength, given the robust health information it provides and procedural ease.”
However, he cautioned, handgrip strength “methodologies are continually evolving and the associations of handgrip strength with clinically relevant outcomes are wide-ranging, thus healthcare providers should understand how to administer handgrip strength protocols and what handgrip strength is assessing.”
No source of study funding was reported. The authors and Fargo report no relevant financial relationships.
J Am Geriatr Soc. Published online May 30, 2020. Abstract
https://www.medscape.com/viewarticle/931979#vp_1
Investigators analyzed handgrip strength in over 17,000 adults aged 50 years and older and found that those with both asymmetry and weakness had a twofold increase risk of accelerated cognitive decline.
In particular, those with the greatest odds for lower cognitive functioning had considerably more strength in their nondominant than their dominant hand.
“Having weakness, as measured by maximal handgrip strength, and/or wide strength differences between hands, could be a clue for low cognitive functioning,” lead author Ryan McGrath, PhD, assistant professor in the Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, told Medscape Medical News.
“If a person has weakness and/or handgrip strength asymmetry, a more comprehensive cognitive evaluation may want to be considered — or even evaluations of other age-related health conditions such as frailty,” McGrath said.
The study was published online May 30 in the Journal of the American Geriatric Society.
Indicator of Neural System Deficits
“There is an accumulating amount of evidence that physical measures, such as handgrip strength, are associated with cognitive impairment,” McGrath said.Previous studies focusing on cognition indicate that imbalances in muscle strength “could be linked to the neural system deficits that drive low cognitive functioning.”
The researchers therefore “wanted to enhance handgrip strength protocols by also evaluating handgrip strength asymmetry because we are usually only interested in maximal handgrip strength,” said McGrath.
To investigate, the researchers analyzed a sample of 17,163 individuals (median age, 65 years [SD, 10.1 years]; 42.2% male; 68.1% non-Hispanic white; 17.7% non-Hispanic black), drawn from the 2006 to 2016 waves of the Health and Retirement Study, a longitudinal study that monitors a variety of factors in aging Americans.
Most participants rated their health as “very good” or “good” (31.2% and 31.8%, respectively).
The researchers assessed cognitive function at each wave of the study using the Telephone Interview for Cognitive Status with “lower” status defined as ≤ 11 for participants ages 50‐64 years and ≤ 10 for those aged ≥ 65 years.
Handgrip strength of both dominant and nondominant hands was measured using a handgrip dynamometer, with “weakness” defined as handgrip strength < 26 kg in men or < 16 kg in women.
Participants with handgrip strength > 10% stronger on either hand were considered as having “any [handgrip strength] asymmetry,” and participants with handgrip strength > 10% stronger on their dominant or nondominant hand were considered as having “dominant” or “nondominant” handgrip strength asymmetry, respectively.
Quick, Feasible Screen
Of the 17,163 study participants, 48% had symmetric handgrip strength, 43% had dominant handgrip strength asymmetry, and 9% had nondominant handgrip strength asymmetry.Compared with participants with symmetric handgrip strength and no weakness, those with any handgrip strength asymmetry alone had 15% greater odds for lower cognitive functioning, participants with weakness alone had 64% greater odds for lower cognitive functioning, and those with both handgrip strength asymmetry and weakness had 95% greater odds for lower cognitive functioning.
“The associations for low cognitive function [and handgrip asymmetry] were exacerbated when those with handgrip strength asymmetry also had weakness,” said McGrath.
“We recommend that measures of handgrip strength asymmetry be used alongside assessment of weakness to improve the prognostic value of handgrip dynamometers,” he added.
He noted that the “feasibility for completing handgrip strength measurements are high [and] opportunities for measuring handgrip strength at home are emerging.”
Simple Tool
Commenting on the study for Medscape Medical News, Keith Fargo, PhD, director of scientific engagement for the Alzheimer’s Association, said the finding is “intriguing” but added that it “needs to be replicated in larger and more diverse study groups.”Fargo, who was not involved with the study, said that it is “important to note that handgrip strength is not a tool used to assess current or future cognitive function, and that this topic may be worth further investigation, since it is relatively simple to administer and measure.”
McGrath noted that some healthcare providers use measures of handgrip strength to primarily assess muscle function, “but overall the use of handgrip strength in routine geriatric health assessments is generally absent.”
He encourages healthcare providers “to use measure of handgrip strength, given the robust health information it provides and procedural ease.”
However, he cautioned, handgrip strength “methodologies are continually evolving and the associations of handgrip strength with clinically relevant outcomes are wide-ranging, thus healthcare providers should understand how to administer handgrip strength protocols and what handgrip strength is assessing.”
No source of study funding was reported. The authors and Fargo report no relevant financial relationships.
J Am Geriatr Soc. Published online May 30, 2020. Abstract
https://www.medscape.com/viewarticle/931979#vp_1
‘Anxiety Screening Recommended for All Women’ – ACOG-Linked Group
Young women ages 13 and up, including those who are pregnant or have
just given birth, should be screened for anxiety at routine visits,
according to a Women’s Preventive Services Initiative (WPSI) recommendation released Monday.
In the 10 systematic reviews used to form the evidence base of this recommendation, there was sufficient evidence supporting the accuracy of screening tools and the efficacy of available anxiety treatments, including cognitive behavioral therapy and pharmacologic therapies, reported Heidi Nelson, MD, MPH, and other colleagues at WPSI.
However, no studies looked at the overall effectiveness and harms of anxiety screening, they wrote in the new guideline published in the Annals of Internal Medicine.
“Even though we estimate 40% of women experience anxiety throughout their lifetime, only 20% of men and women actually seek care,” Nelson told MedPage Today. “There is really a gap between the experience of screening and the treatment of anxiety.”
Led by the American College of Obstetricians and Gynecologists, the WPSI is a national program in partnership with the federal Health Resources and Services Administration and involvement from other medical groups. It develops recommendations on clinical issues that have not been addressed by groups like the U.S. Preventive Services Task Force (USPSTF).
The USPSTF currently recommends screening all adults and adolescents ages 12-18 for depression, but similar recommendations do not exist for anxiety.
Although anxiety is also diagnosed in about 20% of men, the WPSI determined that women have unique needs because they experience anxiety triggers such as sexual harassment or eating disorders at higher rates, Nelson said.
Rates of anxiety are rising nationally amid the COVID-19 pandemic, amplifying the need for increased screening and treatment, Nelson added.
“What’s nice about these types of instruments is that they can be done online with a remote appointment,” Nelson said. “Asking a few extra questions … and opening that door reveals many other things that can help people cope with the situation we are under now.”
In the evidence review of studies conducted in community, primary care, and obstetrics clinics, most screening tools showed moderate to high accuracy in good or fair quality studies, Nelson and co-authors reported, noting that for some tools, the short version fared equally well as longer versions, including the Generalized Anxiety Disorder 2-item questionnaire versus the 7-item questionnaire (GAD-2 vs GAD-7).
Moreover, some tools worked just as well in children and adults, including the GAD-7 and the Hospital Anxiety and Depression Scale, researchers reported.
“Use of the most brief and universal, yet effective, instruments could facilitate integration of anxiety screening into routine clinical practice,” Nelson and co-authors wrote.
However, the jury is still out on whether anxiety screening can be effectively implemented, commented Kim Smolderen, PhD, and Matthew Burg, PhD, both of Yale University in New Haven, Connecticut, in an accompanying Annals editorial.
A total of 27 screening tools were identified in the review, and “clearer directives for how to approach screening could promote uptake of the guidelines in real-world clinical settings,” Smolderen and Burg noted.
Also, “when promoting screening, it is important to reflect on what happens when anxiety is detected,” they wrote.
Namely, women may experience long-term side effects of pharmacologic agents commonly used to treat anxiety, which not only include benzodiazepines but also SSRI/SNRI antidepressants. Medications need to be monitored particularly closely in pregnant or postpartum women, the editorialists noted.
In the evidence review, adverse events were not documented with CBT, but they were common in drug trials. For example, in one high-quality trial, 63% of adults on SSRIs and SNRIs reported at least one adverse event, including sexual dysfunction, weight gain, nausea, and fatigue, researchers reported.
Patients who screen positive for anxiety may also have trouble accessing affordable CBT, wrote Smolderen and Burg, adding that women of color, sexual minorities, and women residing in rural areas disproportionately face obstacles in obtaining mental health care.
“Implementation of mental health screening is most likely to be effective within a collaborative care context, in which well-organized paths are in place to care for those identified with a condition,” they wrote. “Without such a collaborative care context, it is not apparent that the act of screening in itself would provide benefit.
https://www.medpagetoday.com/psychiatry/anxietystress/86950
In the 10 systematic reviews used to form the evidence base of this recommendation, there was sufficient evidence supporting the accuracy of screening tools and the efficacy of available anxiety treatments, including cognitive behavioral therapy and pharmacologic therapies, reported Heidi Nelson, MD, MPH, and other colleagues at WPSI.
However, no studies looked at the overall effectiveness and harms of anxiety screening, they wrote in the new guideline published in the Annals of Internal Medicine.
“Even though we estimate 40% of women experience anxiety throughout their lifetime, only 20% of men and women actually seek care,” Nelson told MedPage Today. “There is really a gap between the experience of screening and the treatment of anxiety.”
Led by the American College of Obstetricians and Gynecologists, the WPSI is a national program in partnership with the federal Health Resources and Services Administration and involvement from other medical groups. It develops recommendations on clinical issues that have not been addressed by groups like the U.S. Preventive Services Task Force (USPSTF).
The USPSTF currently recommends screening all adults and adolescents ages 12-18 for depression, but similar recommendations do not exist for anxiety.
Although anxiety is also diagnosed in about 20% of men, the WPSI determined that women have unique needs because they experience anxiety triggers such as sexual harassment or eating disorders at higher rates, Nelson said.
Rates of anxiety are rising nationally amid the COVID-19 pandemic, amplifying the need for increased screening and treatment, Nelson added.
“What’s nice about these types of instruments is that they can be done online with a remote appointment,” Nelson said. “Asking a few extra questions … and opening that door reveals many other things that can help people cope with the situation we are under now.”
In the evidence review of studies conducted in community, primary care, and obstetrics clinics, most screening tools showed moderate to high accuracy in good or fair quality studies, Nelson and co-authors reported, noting that for some tools, the short version fared equally well as longer versions, including the Generalized Anxiety Disorder 2-item questionnaire versus the 7-item questionnaire (GAD-2 vs GAD-7).
Moreover, some tools worked just as well in children and adults, including the GAD-7 and the Hospital Anxiety and Depression Scale, researchers reported.
“Use of the most brief and universal, yet effective, instruments could facilitate integration of anxiety screening into routine clinical practice,” Nelson and co-authors wrote.
However, the jury is still out on whether anxiety screening can be effectively implemented, commented Kim Smolderen, PhD, and Matthew Burg, PhD, both of Yale University in New Haven, Connecticut, in an accompanying Annals editorial.
A total of 27 screening tools were identified in the review, and “clearer directives for how to approach screening could promote uptake of the guidelines in real-world clinical settings,” Smolderen and Burg noted.
Also, “when promoting screening, it is important to reflect on what happens when anxiety is detected,” they wrote.
Namely, women may experience long-term side effects of pharmacologic agents commonly used to treat anxiety, which not only include benzodiazepines but also SSRI/SNRI antidepressants. Medications need to be monitored particularly closely in pregnant or postpartum women, the editorialists noted.
In the evidence review, adverse events were not documented with CBT, but they were common in drug trials. For example, in one high-quality trial, 63% of adults on SSRIs and SNRIs reported at least one adverse event, including sexual dysfunction, weight gain, nausea, and fatigue, researchers reported.
Patients who screen positive for anxiety may also have trouble accessing affordable CBT, wrote Smolderen and Burg, adding that women of color, sexual minorities, and women residing in rural areas disproportionately face obstacles in obtaining mental health care.
“Implementation of mental health screening is most likely to be effective within a collaborative care context, in which well-organized paths are in place to care for those identified with a condition,” they wrote. “Without such a collaborative care context, it is not apparent that the act of screening in itself would provide benefit.
https://www.medpagetoday.com/psychiatry/anxietystress/86950
FDA grants orphan drug designation to Agios’s mitapivat for thalassemia
Agios Pharmaceuticals (NASDAQ:AGIO) +4.4% AH as the company receives FDA orphan drug designation to its pyruvate kinase-R (“PKR”) activator mitapivat for thalassemia.
Mitapivat was previously granted orphan drug
designation by the FDA and EMA for pyruvate kinase (“PK”) deficiency, a
rare, debilitating, hemolytic anemia.
https://seekingalpha.com/news/3581331-fda-grants-orphan-drug-designation-to-agioss-mitapivat-for-thalassemiaGoogle Maps to alert users about COVID-19-related travel restrictions
Google is adding features on its Maps service to alert users about
COVID-19-related travel restrictions to help them plan their trips
better, the Alphabet Inc unit said on Monday.
The update would allow users to check how crowded a train station might be at a particular time, or if buses on a certain route are running on a limited schedule, Google said.
The transit alerts would be rolled out in Argentina, France, India, Netherlands, the United States and United Kingdom among other countries, the company said here in a blog post.
The new features would also include details on COVID-19 checkpoints and restrictions on crossing national borders, starting with Canada, Mexico and the United States.
In recent months, the company has analyzed location data from
billions of Google users’ phones in 131 countries to examine mobility
under lockdowns and help health authorities assess if people were
abiding with social-distancing and other orders issued to rein in the
virus.
Google has invested billions of dollars from its search ads business to digitally map the world, drawing 1 billion users on average every month to its free navigation app.
https://www.reuters.com/article/us-health-coronavirus-google/google-maps-to-alert-users-about-covid-19-related-travel-restrictions-idUSKBN23F26N
The update would allow users to check how crowded a train station might be at a particular time, or if buses on a certain route are running on a limited schedule, Google said.
The transit alerts would be rolled out in Argentina, France, India, Netherlands, the United States and United Kingdom among other countries, the company said here in a blog post.
The new features would also include details on COVID-19 checkpoints and restrictions on crossing national borders, starting with Canada, Mexico and the United States.
Google has invested billions of dollars from its search ads business to digitally map the world, drawing 1 billion users on average every month to its free navigation app.
https://www.reuters.com/article/us-health-coronavirus-google/google-maps-to-alert-users-about-covid-19-related-travel-restrictions-idUSKBN23F26N
Fed eases terms of Main Street loans, tells banks to start disbursing
The U.S. Federal Reserve eased the terms of its “Main Street” lending
program on Monday, lowering the minimum loan size from $500,000 to
$250,000 and lengthening the term from four to five years to encourage
more businesses and banks to participate.
In an announcement, the central bank also encouraged lenders to start making the loans to small and medium-sized businesses “immediately” once they are registered with the Fed to participate in the program.
The changes address concerns raised by some lenders, lawyers and
small business consultants that the previous minimum loan amount of
$500,000 was too large to help many businesses affected by the
coronavirus pandemic.
“Supporting small and mid-sized businesses so they are ready to reopen and rehire workers will help foster a broad-based economic recovery,” Federal Reserve Chair Jerome Powell said. “I am confident the changes we are making will improve the ability of the Main Street Lending Program to support employment during this difficult period.”
Some small lenders previously said they were worried about taking on
too much risk. But the Fed is further minimizing the downside for banks
and credit unions that participate by purchasing 95% of all loans issued
through the program. Previously, the central bank agreed to purchase
85% or 95% of the loan, depending on the type of loan.
The Fed also gave businesses more time to repay their loans, which could help small businesses that would otherwise struggle to pay back the loans. Loans will now last five years and borrowers will not owe payments on the principal for the first two years. Previously, loans were set to last four years, with no payments due the first year.
https://www.reuters.com/article/us-usa-fed-mainstreet/fed-eases-terms-of-main-street-loans-tells-banks-to-start-disbursing-idUSKBN23F2N8
In an announcement, the central bank also encouraged lenders to start making the loans to small and medium-sized businesses “immediately” once they are registered with the Fed to participate in the program.
“Supporting small and mid-sized businesses so they are ready to reopen and rehire workers will help foster a broad-based economic recovery,” Federal Reserve Chair Jerome Powell said. “I am confident the changes we are making will improve the ability of the Main Street Lending Program to support employment during this difficult period.”
The Fed also gave businesses more time to repay their loans, which could help small businesses that would otherwise struggle to pay back the loans. Loans will now last five years and borrowers will not owe payments on the principal for the first two years. Previously, loans were set to last four years, with no payments due the first year.
https://www.reuters.com/article/us-usa-fed-mainstreet/fed-eases-terms-of-main-street-loans-tells-banks-to-start-disbursing-idUSKBN23F2N8
Gilead files remdesivir application in Europe
The European Medicines Agency (EMA) reports that Gilead Sciences (GILD +0.6%) has submitted its marketing application seeking conditional approval of antiviral remdesivir for the treatment of COVID-19.
Considering that the regulator has already
reviewed quality and manufacturing data, preliminary results from
several clinical trial and supporting data from compassionate use
programs, the review timeline will be shortened and the advisory group
CHMP may issue an opinion “within weeks.” If positive, the EMA will work
closely with the European Commission to fast track a final decision.
Remdesivir is currently approved for emergency use
in the U.S. and Japan. The nod in Australia is imminent after a
taskforce backed approval last week.
https://seekingalpha.com/news/3581253-gilead-files-remdesivir-application-in-europe
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