News

Yesterday’s news has become today’s news, and likely will be tomorrow’s news, too.

Synthetic cannabinoids are not new, and yet, they continually find their way back into the news. They return in the form of dangerous new variations, with more menacing and ironic names; while promising greater potency, and, so, more thrills. But these familiar and still illicit substances can be 85-times more powerful than marijuana. This “industrial strength” poison threatens users with both new symptoms and possibly significant harm. 

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Synthetic cannabinoids first made national news on July 12, 2016, when the New York City Emergency Medical Services (EMS) were summoned to a block party in the Bedford-Stuyvesant neighborhood of Brooklyn. On the street, groups of partiers exhibited altered states of consciousness that would later be described as “zombie-like.” The zombie name struck a chord and stuck. The actual name of the substance, AMB-FUBINACA, was not nearly as well known. 

Two years earlier in Louisiana, a similar outbreak was attributed to an AMB-FUBINACA analog with the “trademarked” name “Train Wreck 2.” We don’t want to be seen as not taking this problem seriously. We do, so much in fact, that we’ve committed substantial resources to bring our panels to the fore of the industry. But we also think it would be a mistake for the medical industry and substance abuse specialists not to recognize the ingenuity and creativity of those who manufacture and distribute these substances. Ignoring this reality could prove detrimental to our finding new ways to detect new drugs through clinical testing. This is particularly true as the makers of these drugs are constantly innovating and creating new products, often with only slightly varied recipes.

In response to this shape-shifting phenomenon,
Acutis has launched its updated Spice Menu,
with new assays to reflect these barreling trends. 

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These include 20 new analytes, including our AMB-FUBINACA and 5F-ADB tests for the substances which represent over 61% of reported synthetic cannabinoids used in the U.S. These steps are of critical importance, particularly as young people are increasingly vaping drugs like K2, 24K Gold, and AK-47. The vaping trend is growing even as smoking in the traditional sense has fallen out of fashion.

As the article, “‘Zombie’ Outbreak Caused by the Synthetic Cannabinoid AMB-FUBINACA in New York” in the December 2016 issue of The New England Journal of Medicine by Axel J. Adams, B.S, Samuel D. Banister, PhD., Lisandro Irizarry, M.D. et al, made clear: Commonly abused drugs are undergoing a period of proliferation and diversification … [while] new psychoactive substances are providing users with alternatives to older and better-characterized drugs, such as amphetamines, heroin, cocaine, and cannabis.” The article reports that more than “540 new psychoactive substances have been reported to the United Nations Office on Drugs and Crime.” 

And, of these, synthetic cannabinoids are the fastest growing class. Since 2008, there has been a significant uptick in the use of synthetic cannabinoids. First called “K2” in America and “Spice” in Europe, these designer drugs have a completely different chemical structure from plant-based THC, and so there’s nothing natural or predictable about the high.

We can expect to see an increase in the use of these drugs because of their low cost and the potential for dilution into large volumes of product. In light of these facts, Acutis will work with the medical community to develop ever and ever more sensitive tests to help identify even the faintest presence of the metabolites indicating AMB-FUBINACA and other, newer synthetics. 

We will also continue to research and expand our tests because as the article from The New England Journal of Medicine observed: The analysis of new psychoactive substances requires more than the typically targeted drug panels, [which is to say] success will rely on more sophisticated analytic platforms. [Platforms] that have the ability to rapidly identify previously unreported compounds.” 

We will judge our progress not only by developing the science and technology to detect very low concentrations of a drug or its metabolites, but also to predict and rapidly generate reference standards for previously unknown psychoactive substances. 

To learn more about Acutis’ work in this area, contact service@acutisdiagnostics.com

Putting the focus back on treatment.

At some point or another, a scandal touches every industry; medicine is no exception. But seldom has one name scorched so many great cultural institutions as that of the Sackler family. The affected museums, universities, and foundations that were beneficiaries of the Sackler family’s largesse include: The Metropolitan Museum of Art, the Tate Gallery, The Smithsonian, the Guggenheim, Yale, The New York Academy of Sciences, and other renowned institutions.

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The crisis of conscience experienced by these institutions and also the righteous anger of the attorney generals across the nation who are suing both members of the family, as well as the family-owned company, Purdue Pharma, was caused by the misuse of OxyContin, the company’s best-selling product. The irony is that this medicine, hailed as a wonder drug, offered doctors a way to alleviate severe pain suffered by countless patients including those with cancer and terminal illnesses.

Both Purdue and members of the family have been accused of aggressive, reckless, and even criminal marketing of the drug; including encouraging their sales force to ignore the practice of unethical doctors who ran infamous pill mills. As a result, this former “miracle drug” has become a symbol of the most despicable kind of corporate greed. Although some might argue that Purdue and the Sacklers have become scapegoats for a society that has failed to treat a decades-long catastrophe in a responsible, let alone effective way.

The discussion entered the mainstream with an article in The New Yorker magazine, “The Family That Built an Empire of Pain,” by Patrick Radden Keefe. Since its publication in October 30, 2017, the story of OxyContin and its role in our nation’s very real “opioid crisis” has only grown more intense. 

As a company working at the leading edge of clinical toxicology, Acutis has developed innovative technologies and science and advanced methodologies that enable our medical and drug treatment clients to quickly identify the misuse of OxyContin, as well as other prescription and illicit drugs, including natural and semisynthetic opioids, synthetic opioids, methadone, fentanyl, tramadol, and heroin.

Throughout our collaborations with doctors and our peers in the industry, our conversations have moved outside the lab and into the culture at large. These conversations have made us extremely aware of all that’s at risk by ignoring the real problem.

First, there is the complexity of managing pain, an imperfect art that physicians and others who help suffering people must practice. Second, these professionals do their work fully aware of the frailty of these human beings and their susceptibility to addiction.

The New Yorker’s investigation brought to the surface countless intersecting dynamics that help us understand a cause of crisis—from Purdue’s aggressive marketing practices and the greed of a small number of doctors, to the desperate financial situations of patients who found themselves in possession of a valuable commodity. We also learned a great deal of the role these drugs play in the lives of men and women living in depressed, largely rural and impoverished places.

The story of the Tate Gallery’s and other’s repudiation of new funding by the Sackler trusts, as well as the noisy, even vengeful protests, led by the artist Nan Goldin make for a good story. That said, Acutis has never chased headlines. In fact, we are saddened by the growing number of lawsuits, both those brought by Attorney Generals and also litigators on behalf of their clients. Some settlements have already been made and others will be litigated with the expectation of reclaiming some of the costs related to the 1,000s of deaths attributed to OxyContin.

But we think the emphasis on the Sackler Family and OxyContin, which is still, when used as prescribed, a great help to people suffering from terrible pain, is misguided.

As a company intimately familiar with the workings and expectations of physicians and substance-abuse practitioners and facilities, Acutis refuses to be distracted by sensational news. Nor will we point our finger at a convenient villain.

Few things are as seductive as watching the mighty fall, or the opportunity to turn up our noses at “filthy lucre,” or witness the humbling of the glamorous art world. That said, we will leave the schadenfreude and moralizing to politicians, activists, and cultural critics.

Our task as a clinical toxicology lab is to continually refine our science and technology to provide our clients with the best tools to address the real threats to our individual and collective well-being. We will judge ourselves solely by the following criteria: The precision of our results, delivered in the most timely manner, which together enables our clients in the healthcare community to provide the most appropriate treatment. This is our work and no news, no matter how sensational, will distract us from it

February is, historically, the month with the most reported cases of Influenza.

What are the facts?

  • We are in the midst of 2019 flu season and February is, historically, the month with the highest rate of Influenza.

  • The CDC recommends an annual flu vaccine for everyone 6 months and older.

  • The flu vaccine is the best way to reduce your risk of flu and its potentially serious consequences.

  • Acutis Reveal can determine if you are suffering from the flu or simply a cold.

  • The facts are not in dispute: Get vaccinated today.

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As we wrote elsewhere, flu is not easy. One reason, as the Centers for Disease Control (CDC) reminds us, is that each season introduces different viruses. To provide optimum protection, the makeup of U.S. flu vaccines is updated to match the current circulating flu viruses.

Once you’ve received your shot, it takes about two weeks for the antibodies to develop in the body. So, even if you haven’t had the shot yet, this is a case where later is better than never. As the season could last well into May, even a late vaccination can prove beneficial. This is especially true for high-risk individuals. These include young children, pregnant women, people with chronic health conditions, and the elderly.

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The words “Flu Season” are meant to be taken literally. They are not used metaphorically. It is not medicine taking poetic license. Flu can be active from October until May.

As the flu spreads—from the most intimate settings, to the most public spaces—the Centers for Disease Control suggests we take these precautions to stop the spread of the viruses:

· As much as possible, try to avoid close contact with people suffering from the flu or who show signs of the flu.

· If you’re ill, limit contact with others to avoid infecting them.

· If you have flu-like symptoms, the CDC recommends you stay home for at least 24 hours after your fever is gone. Leave your home only to seek medical care or for other necessities.

· Cover your nose and mouth with a tissue when you cough or sneeze. After using a tissue, throw it in the trash and then wash your hands.

· Wash your hands frequently using soap and water. If soap and water are not available, use an alcohol-based hand sanitizer.

· Avoid touching your eyes, nose, and mouth. Germs spread this way.

· Clean and disinfect surfaces and objects that may be contaminated with flu germs.

Flu vs Cold

One of the most confusing aspects of the flu is that its signs and symptoms resemble the common cold and other less dangerous illnesses. See the list below to better determine the nature of your illness, or those of the people around you.

 
 


Flu complications can be more than a little complicated

Most people who get the flu will recover in anywhere from a few days to a couple of weeks. But for those who develop complications such as pneumonia, complications can lead to serious illness, even death.

Sinus and ear infections are examples of moderate complications from the flu, while pneumonia is a serious flu complication that can result from either influenza virus infection or from co-infection of flu virus and bacteria. Other possible serious complications triggered by the flu can include inflammation of the heart (myocarditis), brain (encephalitis), or muscle (myositis, rhabdomyolysis) tissues, and multi-organ failure (for example, respiratory and kidney failure). Flu virus infection of the respiratory tract can trigger an extreme inflammatory response in the body and can lead to sepsis, the body’s life-threatening response to infection.

The flu also can make chronic medical problems worse. For example, people with asthma may experience more violent asthma attacks when suffering from the flu, and people with chronic heart disease may experience a worsening of their condition.


What are the emergency warning signs of influenza in infants,
children and adults?

Infants. Pay close attention to these signs:

· No appetite or unable to eat
· Difficulty breathing
· No tears when crying
· Fewer wet diapers than normal

Children. Watch for these symptoms:

·
 Fast breathing or trouble breathing
· Bluish skin color
· Refusing fluids
· Difficulty waking or interacting
· Irritability and refusing to be held
· “False recovery”— a fever returns along with painful cough
· Fever with a rash

Adult. Look for these indications:

·
 Difficulty breathing or shortness of breath
· Pain or pressure in the chest or abdomen
· Sudden dizziness
· Confusion
· Severe or persistent vomiting
· Flu-like symptoms that improve but then return with fever and worse cough

Acutis Diagnostics recognized by Newsday as a New York success story.

In early December, Acutis was the subject of a feature article by James T, Madore, who writes about Long Island business for NewsdayThe piece describes our work, our rapid growth, and also our plans to expand our current competencies. In the piece, Acutis is described as a “great success story.” As a company in motion and as one committed to the medical community and the public its serves, everyone at Acutis is happy to share this story with you,

A clinical laboratory involved in the fight against opioid addiction and misuse of antibiotics wants to quadruple its space by moving west, from Suffolk County to Nassau, executives said.Acutis Diagnostics Inc., begun three years ago, has grown from two employees working in 1,000 square feet of space in Farmingdale to more than 100 in 10,000 square feet in East Northport. And the company now is looking to buy a 40,000-square-foot building in Hicksville to meet increased demand for its lab tests. CEO Jibreel Sarij said recently that the opioid crisis has fueled sales of Acutis’ medication monitoring systems by physicians, drug treatment centers and others.

Read more

Just don’t call it weed

In early July, the U.S. Food and Drug Administration approved Epidiolex® (cannabidiol or CBD), an oral solution derived from marijuana, for the treatment of two severe pediatric seizure disorders. Epidiolex® is the first, yes, the first, FDA-approved medicine made from a purified extract of the marijuana plant—all natural and nothing synthetic.

Studies have confirmed what has been reported anecdotally about CBD oils—that they are helpful in treating seizures. But stories that circulate like rumors have always been incomplete if not disappointing. That said, starting this autumn, parents whose children suffer from Lennox-Gastaut and Dravet syndromes will have a safer and more reliable treatment than CBD products currently hawked on the Internet or sold in marijuana dispensaries.

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FDA approves first drug derived from marijuana.
July 2, 2018

Last week, the Food and Drug Administration(FDA) approved Epidiolex® (cannabidiol, or CBD), a medication extracted from marijuana, for the treatment of two severe pediatric seizure disorders, Lennox-Gastaut syndrome and Dravet syndrome. CBD is a compound typically found in very small quantities in the marijuana plant, and it has been of interest to scientists and the public for several years due to its anti-seizure properties and other possible therapeutic benefits. The approval comes at the end of a four-year series of trials showing the benefits of CBD in relieving the symptoms of these seizure disorders, which are highly resistant to existing treatments.

Lennox-Gastaut and Dravet syndromes are extremely debilitating. Children often suffer multiple seizures per day, they are likely to have developmental problems and are at high risk for early mortality. For several years, desperate parents with children suffering from these disorders sometimes relocated to states where marijuana had been legalized to obtain CBD oils, since this compound had been reported anecdotally to be helpful.

Read the full article online on the National Institute on Drug Abuse (NIDA) website.

Surprising and disturbing

Best business practices require a familiarity with current news. Toward that end, we read industry white papers and university studies, as well as national and local news stories. But familiarity is our point of departure.

News that finds its way into our laboratory will often find its way into our strategies and eventually into new services. Where this particular story leads we can’t say, but as we found it as surprising as it is disturbing, we believe it is worth publishing here.

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Mussels in Washington's Puget Sound test positive for opioids, other drugs

“Shellfish in the Puget Sound, an inlet of the Pacific Ocean along the northwest coast of Washington, tested positive for the prescription opioid oxycodone... The mussels also contained four kinds of synthetic surfactants -- the chemicals found in detergents and cleaning products -- seven kinds of antibiotics, five types of antidepressants, more than one anti-diabetic drug and one chemotherapy agent.”

“Scientists have not studied whether mussels are harmed by oxycodone. However, the presence of this drug in the mollusk speaks to the high number of people in the urban areas surrounding the Puget Sound who take this medication, said Lanksbury.”

"We decided it was important for us to start looking for 'contaminants of emerging concern,' " she said. This term refers to pharmaceuticals and personal care products -- including prescription drugs, detergents, shampoos and micro-plastic beads -- that are increasingly being detected in waterways, such as the Puget Sound.

A study conducted by the US Geological Survey found measurable amounts of one or more medications in 80% of the water samples drawn from 139 streams in 30 states.”

Follow this and related stories:

Fentanyl-laced heroin overdoses rise California signaling higher need for clinical caution

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The CDC reports that opioids of all types have killed more than 33,000 people in 2015 alone, and the number is rising. A newer threat of mixed opioids plagues Ventura County in California and could signal a need for more caution across the country.

Ventura County has reported a rise in fatal opioid overdoses that could be attributed to the spread of heroin laced with fentanyl. “People are using these drugs expecting one result and getting a much more potent result, a result that can end up with death,” says Dr. Robert Levin, a physician and public health officer in the county. The public health officials of the county note that opiates can be accessed very easily, sometimes by mail order, and that there is very little oversight in the mixes of opioids that people are purchasing illegally.

Some forms of synthetic opioids are significantly easier to produce and sell illegally than are others. Carfentanyl and fentanyl are both extremely potent in small quantities and present an extreme health risk as a result. Synthetic opioids as a whole have caused 72.2% more deaths from 2014 to 2015, according to the CDC. The CDC also reports that the rates at which confiscated drugs testing positive for fentanyl are growing faster than prescription rates. This indicates that synthetic opioids like fentanyl are further infiltrating the street and illicit drug use scene.

It is the mixing of synthetic opioids with heroin that is most troubling, especially for Ventura County. Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine. Heroin, in comparison, is two to four times as potent as morphine, according to a research article in the Journal of Pharmacology and Experimental Therapeutics. Mixing fentanyl and heroin can easily produce an opioid dose that exceeds the potency of safely prescribed amounts of opioids by several orders of magnitude.

What can be done about this problem?

Ultimately, opioid dependence and addiction must be resolved under supervision of a qualified health provider. A core component of any addiction or dependence treatment program is toxicology-based monitoring for compliance and for metrics. Acutis Diagnostics is a New York toxicology lab that works closely with the medical and patient community to ensure safe, healthy, and timely treatment of all disorders, including opioid dependence and addiction. Please contact Acutis Diagnostics to learn how the services offered here can help provide a path to treatment for all patients.

For more information about the recent events in Ventura County, please look at this article by the Ventura County Star.

For more information about fentanyl and to see a wealth of information about the opioid crisis, visit the CDC’s page about fentanyl here.

To read the Journal of Pharmacology and Experimental Therapeutics’ article about equivalent doses of heroin and morphine, please click here.

This article is written by Yusuf Sheth. Yusuf is a Masters of Public Health Candidate at Downstate Medical Center.

Marijuana wins big on election night

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Voters in California, Massachusetts and Nevada approved recreational marijuana initiatives Tuesday night, and several other states passed medical marijuana provisions, in what is turning out to be the biggest electoral victory for marijuana reform since 2012, when Colorado and Washington first approved the drug's recreational use.

In addition to the states above, local outlets in Maine are declaring victory for that state's legalization measure, but with 91 percent of precincts reporting just a few thousand votes separate the "Yes" and "No" columns.

A similar legalization measure in Arizona did not gain sufficient support to pass, with 52 percent of voters rejecting it.

On the medical side, voters in Florida, North Dakota and Arkansas have approved medical marijuana initiatives. Voters in in Montana also rolled back restrictions on an existing medical pot law.

Reformers were jubilant. “This represents a monumental victory for the marijuana reform movement,” said Ethan Nadelmann, executive director of the Drug Policy Alliance, in a statement. “With California’s leadership now, the end of marijuana prohibition nationally, and even internationally, is fast approaching.”

California has long been seen as a bellwether by both supporters and opponents of marijuana reform. The state is home to about 12 percent of the U.S. population. Given the size of the state's economy and the economic impact of the marijuana industry there, California's adoption of legal marijuana could prompt federal authorities to rethink their decades-long prohibition on the use of marijuana.

In a recent interview with Bill Maher, President Obama said that passage of the legalization measures on Tuesday could make the current federal approach to the drug “untenable.”

Still, the likelihood of a Trump White House leaves a lot of uncertainty about the fate of marijuana measures in the next four years. Under Obama, federal authorities largely took a hands-off approach to state-level legalization efforts. But an incoming administration more skeptical of drug reform could easily reverse that approach.

“The prospect of Rudy Giuliani or Chris Christie as attorney general does not bode well,” the Drug Policy Alliance's Nadelmann said in an interview. “There are various ways in which a hostile White House could trip things up.”

Nadelmann pointed to the success of marijuana measures in the midst of an evident Republican wave as a sign that support for legalization now cuts deeply across party lines. And citing Trump's often contradictory statements on marijuana and drug use in the past, Nadelmann added that “Donald Trump personally could probably go any which way on this.”

With today's votes, legal marijuana is also making significant inroads in the Northeast. “Marijuana legalization has arrived on the East Coast,” said Tom Angell of the marijuana reform group Marijuana Majority in an email. “What Colorado and other states have already done is generating revenue, creating jobs and reducing crime, so it’s not surprising that voters in more places are eager to end prohibition.”

Opponents of legalization said they were disappointed by the outcomes. “We were outspent greatly in both California and Massachusetts, so this loss is disappointing, but not wholly unexpected,” said Kevin Sabet of the anti-legalization group Smart Approaches to Marijuana in a statement. “Despite having gained considerable ground in the last few weeks, the out-of-state interests determined to make money off of legalization put in too much money to overcome.”

Votes on medical marijuana in Florida and North Dakota were decisive. Florida's Amendment 2 passed with 71 percent support, according to the Associated Press. In North Dakota, the AP reportsthat 64 percent of voters approving of the medical marijuana measure.

Two years ago, a medical marijuana measure in Florida earned 58 percent of the vote, just shy of the 60 percent threshold needed for passage. Then, as now, opposition to the measure was fueled by multimillion-dollar donations from Sheldon Adelson, the Las Vegas casino magnate and GOP donor. In 2014 Adelson spent $5.5 million to defeat the measure. This year he's spent $1.5 million in Florida, and several million more to defeat recreational marijuana measures in other states.

“This is a major tipping point,” said Tom Angell of Florida's vote. “With Florida's decision, a majority of states in the U.S. now have laws allowing patients to find relief with medical marijuana, and these protections and programs are no longer concentrated in certain regions of the country like the West and Northeast.”

The victory in North Dakota is something of a surprise as no polling was done on the measure.

The Florida amendment has the potential to be one of the more permissive medical marijuana regimes in the nation. In addition to diseases like HIV, cancer and PTSD, the measure also allows doctors to recommend medical pot for “other debilitating medical conditions of the same kind or class as or comparable to those enumerated, and for which a physician believes that the medical use of marijuana would likely outweigh the potential health risks for a patient.” While the 2014 measure allowed doctors to prescribe marijuana for any illness they believed it would be useful for, the new measure requires they show the illness is severe — though the wording gives physicians considerable leeway in determining which conditions would meet those criteria.

The medical pot measure in North Dakota allows doctors to recommend the drug for a number of severe medical conditions.

With the passage of Amendment 2, Florida will become the first Southern state to enact a robust medical marijuana regime. Medical marijuana is already legal in 25 other states and the District.

“Better late than never,” said Ethan Nadelmann, executive director of the drug reform group Drug Policy Alliance, in a statement. “Most states outside the South already have legal medical marijuana, but the overwhelming victory today in Florida is likely to accelerate the momentum for reform throughout the region.”

Originally published in the Washington Post.

Fighting the Opioid epidemic from the ground up: Teaching rising medical professionals how to use Naloxone

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In April of this year, Wright State University, Ohio was the staging ground for equipping healthcare students to better handle the opioid crisis. A coalition of various local activism and healthcare improvement groups assembled an event to train more than 40 aspiring professionals about how to use naloxone. The group included medical students, healthcare-related undergraduate students, pharmaceutical students, and physician assistant students.

Naloxone, the opioid antagonist used to block the effects of opioids notably in formulations such as Suboxone, has become ubiquitous in the fight against opioid overdose. Law enforcement and other emergency response forces have even begun to train to use it. Naloxone is a critical part of the opioid-dependence treatment. When bundled with buprenorphine in Suboxone, it acts to deter abuse of the opioid while ensuring that the patient does not undergo withdrawal.

The opioid crisis is critically important to healthcare providers today. The CDC reports that 91 Americans die every single day from opioid overdose, including from prescription drugs. Training health practitioners to be able to respond to this is crucial in preventing unnecessary death and getting the proper treatment to these patients.

At Acutis Diagnostics, our goal is to be a clinical tool that ensures the best possible care for the patient. Please visit our testing services page to see how our laboratory can benefit you and your patients: http://www.acutisdiagnostics.com/testing

To read more about the naloxone instruction at Wright University, please see the full article at the Sidney Daily News by following the link below.
https://goo.gl/2FQnQ8

US National toxicology program poised to add IVIVE predictive software to its retinue

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The US National Toxicology Program (NTP) has recently developed a crucial tool for clinicians and toxicologists alike called Integrated Chemical Environment (ICE). ICE is a central access point for toxicology references and for model predictions to a given substance or hazard. This tool allows robust scientific exploration of the interactions of various substances and can be used for exploratory purposes as well as predictive or confirming needs.

Notably, ICE looks to implement a clinical tool called IVIVE. In-vivo-to-in-vitro extrapolation (IVIVE) is a predictive computational tool that enables analyses of substances and interactions from the womb to after birth. This tool can be used for a variety of critical functions past the obvious ones for neonatologists and obstetricians. Linking in vitro activity to in vivo exposures and outcomes can help toxicologists and physicians understand the pathways that drugs take and improve patient outcomes for those of all ages.

The US NTP hopes to include tutorials and tools to enable people of all skill levels and backgrounds to use ICE. The tutorials should include simple answers to frequently-asked questions, guides on how to use various models, and other easily-digestible learning tools. These resources are currently under development. The US NTP predicts a 2018 launch date.

At Acutis Diagnostics, we make it a point to stay abreast of toxicology and clinical news so we can assist our patients and providers in the best ways possible. For more information about how we can help, please visit our testing services page or contact us for more information. http://www.acutisdiagnostics.com/testing