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Corporations fund self-validating studies all the time, but most of them don’t end up published in a 

 by genetic testing company Invitae that is noteworthy for a few reasons.

The researchers were looking to gauge the value that genetic deletions and duplications—called copy number variants (CNV)&mdash;can add to genetic testing. CNVs might be disease-causing or disease-associated (the well-known 

1-variation is an example), but most testing companies do not analyze for them: They typically aren’t detectable by whole-genome chromosomal microarrays often used in disease risk testing. The researchers indicate that more could be known about CNV prevalence and implications if certain advanced next-generation sequencing techniques were more widely used.

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The new study looked to a colossal data set to learn more about the phenomenon. De-identified sequence data for more than 143,000 individuals were included in the search. They found that about 10% of patients who received a report of potential disease-causing variants had CNVs, with examples across medical specialties, accounting for 4.7% of cardiac pathogenic variants to 35% of neurologic examples.

Invitae’s head of medical affairs, Swaroop Aradhya, PhD, was the study’s senior author. He called the intragenic dataset “one of the largest available” to the medical community, and added that the study did more than just help illustrate CNV prevalence. “We were able to discern properties of CNVs that help us distinguish between those most likely to cause disease versus those that exist as natural variation in the human genome,” he said.

The company’s chief medical officer, Robert Nussbaum, MD, said that the findings suggest that “CNVs are not just clinically significant, they are a critical piece of genetic information that can and should be delivered as part of comprehensive clinical testing.”

But incorporating that measure efficiently requires next-generation sequencing platforms that are capable of simultaneously preening for CNVs alongside other sequence variants. And therein lies the sale: Invitae 

 commercial lab to implement such a thing.

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Invitae just published a study that it says shows the necessity of looking for dupications and deletions when testing.

The Importance of Copy Number Variants in Genetic Testing

Twice this week, Western governments have taken punitive action against Russian companies and individuals out of suspicion that they contributed to ongoing cyberwarfare operations, including the now-notorious NotPetya attack that caused massive headaches for healthcare last summer.

, the United States Department of the Treasury slapped a fresh batch of economic sanctions on 

 believed to have provided material or technological support to Russia’s Federal Security Service (FSB) in its cyberwarfare efforts.

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The FSB was blamed for launching NotPetya as a fake ransomware attack directed against Ukrainian infrastructure. Despite apparent efforts to target its spread, the cyberweapon ended up infecting enormous international companies, causing service delays and wiping out billions in revenue. American healthcare entities like Merck and Nuance Communications, both of which have operations or partnerships in Ukraine, fell victim to the attack

For that and other “destabilizing cyber activities”—including cyber intrusions against the US power grid&mdash;US citizens are now forbidden from doing business with firms Digital Security, ERPScan, Embedi, Kvant Scientific Research Institute, and Divetechnoservices. Three Divetechnoservices executives also made the list, and US-based assets belonging to the sanctioned parties are now blocked.

That news was followed a day later by the 

 to label software from Kaspersky, one of the world’s best-known cybersecurity firms, as “malicious” while urging member states not to adopt it. The company, which has continually denied claims that it has nefarious ties to the Russian government, had previously assisted the EU on its “No More Ransomware” campaign, and with efforts to recover from the WannaCry attack that crippled the United Kingdom’s National Health Service in May, 2017.

In the wake of the European Parliament’s declaration, Kaspersky suspended activities with the EU and its participation in the campaign.

“We have protected the EU for 20 years working with law enforcement leading to multiple arrests of CYBERCRIMINALS,” founder Eugene Kaspersky 

, adding that, “The way we conducted public-private partnership is unfortunately ceased until the withdraw of the European Parliament decision.”

banned use of Kaspersky’s anti-virus software

 in federal government machines. While recommending the move, the Department of Homeland Security wrote that Kaspersky’s anti-virus software could gain “broad access to files and elevated privileges on the computers on which the software is installed,” and that ties between “certain Kaspersky officials and Russian intelligence” were 

. Russian law also allows the country’s intelligence agencies to compel compliance and assistance from private companies.

™, cybersecurity experts described the NotPetya attack as intelligently designed and “elegant.” In addition to mechanisms meant to restrain its spread to Ukraine, it also acted differently when it encountered machines running Kaspersky’s software.

 showed that “if the victim machine has avp.exe (associated with Kaspersky antivirus) process running, NotPetya will NOT encrypt the [main file table],” meaning that Kaspersky-protected machines would be recoverable while other systems were destroyed completely.

It remains unclear, according to some experts, why that was the case. In its own analysis of the attack, published a day after it first hit, Kaspersky told infected users “

The company was given the opportunity to respond to the US ban, and it has committed to making its software code open source to disprove allegations of involvement with Russian government activities. It claims to cover over 

 and 270,000 corporate clients around the globe.

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Suspected involvement in destabilization efforts, including the devastating NotPetya attack that rocked healthcare, brought sanctions and killed partnerships this week.

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Concierge Key, a company that works to connect patients with top-notch specialists (for a premium) via mobile app, today launched its services for those using Android smartphones.

The company launched in the first quarter of this year for iOS users in select markets, allowing users to bypass wait times and book appointments with highly-rated specialists, sometimes as soon as the same day. It now has a handful of participating physicians in most states, with concentrations in dense urban centers.

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Company founder and CEO Robert Grant, MBA, built Concierge Key after noticing that his primary care physician had adopted a concierge system—with an annual retainer fee of a few thousand dollars. Realizing that such a service did not exist for specialists, he created one.

“We’ve all been through this bureaucratic, impersonal system that has forgotten we are customers. The whole industry right now is upside down,” Grant told 

™ in a previous interview. “What we tried to build here is something that I and other people in my office would value as consumers.”

Grant, in a statement, noted that the expansion to Android more than doubles the number of smartphone users

 of engaging with Concierge Key’s app. About 53% of all smartphone owners in the US have an iPhone. “We wanted to ensure that our platform was accessible to that user base, too,” he said, adding also that the new locations represented an interest in “expanding the innovative Concierge Key Health service to include even more discerning consumers."

The increased availability doesn’t necessarily double the company’s potential market customer base, however: Android users, as a demographic, have significantly lower median incomes than iPhone users, which may make them less likely to seek a premium service. That trend also seems particularly pronounced in all of the brand’s available markets, as demonstrated by this 

snarkily-titled series of device usage heat maps

Concierge Key isn’t cheap: It’s a $3,000 per-year service for individuals, with more expensive packages to cover family members. But Grant poses it as a value proposition: Rather than forcing patients through into a confusing series of referrals through their primary care physician or insurance company, it allows them to go directly to a curated group of specialists.

“What percentage of flights are done through a travel agent versus online?” he asked during our earlier interview. “It’s just more convenient.”

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“We wanted to ensure that our platform was accessible to that user base, too,”  the company's founder and CEO said. 

Concierge Key Expands Premium Specialist Access App to Android

A subsidiary of Israeli defense company Elbit Systems, announced today that it has raised $11.5 million to continue work on artificial reality (AR) and virtual reality (VR) tools for surgeons.

Elbit does plenty of VR and AR work for military training and operations, and in 2012 it began bringing its experience in simulation to healthcare applications. The resulting spin-off company, Beyeonics, is focused on a product called the Clarity Bionic Visualization Platform, which features a transparent, camera-equipped headset display that “replace[s] surgical microscopes” by projecting visualizations to guide surgeons during ophthalmologic surgeries. That device is accompanied by a processing core that uses analytics tools to enable instantaneous data integration from numerous digital sensors.

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The system has been undergoing clinical trials for about 2 years now. According to the company, it has been successfully tested in more than 20 surgeries both in Israel at Tel Aviv Sourasky Medical Center and in the United States at Renal Consultants of Arizona.

The investors backing Beyeonics were not named, although 

 report that “5 unnamed organizations…including an American corporation in the medical device business” contributed to the round.

“We are proud to have spun-off a company that leverages some of our unique technologies to materially enhance surgeons' capabilities in the operating room,” Elbit Systems CEO Bezhalel Machlis said 

. “This investment will enable Beyeonics to expand product development, to include additional surgical applications and to accelerate commercialization."

 for the company, which reads “Beyeonics” above the phrase “The Future of Surgery.”

And that moniker probably isn’t inaccurate, although Beyeonics is far from alone in the AR/VR surgery and simulation field. Earlier this year, a team in Texas became the first to perform an AR-assisted sinus surgery using technology from a 

. Meanwhile, numerous firms—ranging from startups like Osso VR to established tech giants like Samsung&mdash;are working to create physician and surgeon tools that manipulate their eyes to improve patient outcomes.

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Last summer, its parent company trademarked a wordmark that reads “The Future of Surgery.”

Beyeonics Raises $11.5M to Develop AR and VR for Eye Surgeons

Nearly 3 years ago today, Apple filed a patent for a “low-profile blood pressure measurement system” that “may be incorporated into a portable electronic device, or may be configured for use with, or to otherwise communicate with a portable multi-function device.” The filing just came to light, however, last week.

, which declared the tech giant’s proposition somewhat 

 The publication rightly notes that the technology itself seems in line with almost all of the other portable blood pressure monitors on the market: A small wrist-worn cuff that uses air cells to determine blood flow.

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What is perhaps most interesting is the timing and intention. The patent filing came just weeks after the 2015 release of Apple Watch. That device carried a heart rate monitor from its inception, but last summer—2 years after launch&mdash;the company made a 

 tweak: Rather than just being an add-on feature that users could use to check heart rate, the Apple Watch now sends push notifications that notify wearers if their heart rate elevates unsafely when they are not engaged in exercise.

Such interventional capabilities seem to have been on Apple’s mind when the company applied for this blood pressure monitor patent. “The blood pressure measurement system may provide one or more alerts or message to the user relating to the user's blood pressure, and/or reminders to take blood pressure medications, and compliance with blood pressure medications,” the document states. Those features also exist in other blood pressure monitoring devices, but most of those have been cleared by the FDA as medical devices.

According to the filing, examples of user-directed messages could include accumulated blood pressure reports of previous day, week, or month; hypertensive status; prescription refill reminders; and “stress, wellness or fitness level.”

 doesn’t limit the company’s options for how the blood pressure monitor would be deployed: The system may be placed “on a wrist-worn device (e.g., a watch, wrist-band, or bracelet)” or an article of clothing, while the controller could be located on the same unit or a separate computer or tablet with which it could be integrated.

Apple’s patent application does have provisions for Wi-Fi or Bluetooth connectivity and data collection. It says that the device may optionally garner user data that could be used to inform wearers or improve performance, of for “uses that are also reasonable and consistent with policies and regulations.” Outside application of the data would be preceded by informed consent.

It also doesn’t spell out the company’s intentions blatantly—few patent applications do&mdash;but it does begin by laying out the public health context for the device, noting CDC hypertension prevalence statistics that said 1 in 3 adults had the condition. In the time since, the American Heart Association and American College of Cardiology have 

 that would put that number up to almost 1 in 2.  

The news comes as Apple drives further into the complex, highly-regulated world of healthcare. Last fall, it was announced that the company 

was participating with other tech companies

 in an FDA pre-certification pilot program. The agency and its Commissioner, Scott Gottlieb, MD, have been vocal about their efforts to encourage health-tech innovation and streamline regulatory appraisal of medical devices.  

 as a growing threat in multiple healthcare technology markets: The Apple Watch has been trouble for the wearables market, spurring traditional fitness monitor companies like Fitbit to 

 on the smartwatch front. Meanwhile, the company seems to be prying at the healthcare information sphere, with a feature that 

allows consumers to view their electronic health records

 (EHR) on their iPhones and a brand-new application programming interface (API) that will allow developers to build analytics and monitoring tools using wearable and EHR data.

This isn’t Apple’s only effort to get into the blood pressure monitoring game. Last year, it received a patent for technology that checks blood pressure using iPhone’s front-facing camera. That application was 

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The company has been flirting with the medical device field for longer than some may realize.

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The FDA unleashed a pair of statements today that saw its Commissioner, Scott Gottlieb, MD, talk value-based care, emphasize enhanced patient engagement in drug development, and even name-checked phrases like  “big data.”

The central theme of both announcements (and the documents that accompany them) is communication: 

 centers around the idea of improving communications between device or drug makers and payers, allowing them to more clearly evaluate the innovations before entering into value-based contracts.

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“The FDA believes it’s critical that information provided by manufacturers to payers about their medical products be truthful and non-misleading and that appropriate background and contextual information be provided to enable payers to make informed decisions,” Gottlieb wrote.

The 2 new guidances give specific directions on how healthcare economic information should be expressed and transmitted: 1 involves manufacturer-payer communications, the other regards labeling. The latter is meant to clarify what constitutes “FDA-required labeling” in order to better inform patient care and, again, the forging of value-based contracts.

 came just hours later. It trumpets a new draft guidance for patient input on drug development—particularly as it pertains to new and novel therapies.

“We learn through scientific advances, but also by listening to patients,” Gottlieb wrote. “Our work demands that we must continue to reflect on how we can make the science of drug development and review more modern and more patient-centered, so that approved products impact the metrics that real-world patients and families value most.”

Drug development is changing quickly, the announcement acknowledges, since therapies can be even more specifically-targeted and made for smaller and smaller populations (the genetic element of this trend does not emerge in the text, but it may be a subtext). The announcement does allude to the Breakthrough Therapy designation, through which potentially game-changing developments like CAR-T cell therapy have gained a foothold.

The idea behind the new guidance is that, by gaining a better understanding of what patients go through with certain conditions, the FDA can better shape its benefit-risk assessments. The agency said it had already conducted more than 20 listening sessions with patients suffering a host of chronic conditions. The new guidance specifically pertains to patient data collection, and is to be the first of four on the subject.

And, as always, the announcements were accompanied by tweets. The Commissioner is prolifically active on the social media platform, and today was no exception. He framed the guidances as part of an overarching effort, before moving on to retweet a series of press reports about them:

Our goal is a market that’s competitive, based on outcomes that matter most to patients. Helping facilitate value based contracting for medical products may foster these outcomes, enable better access to medical products, and more affordable options: 

— Scott Gottlieb, M.D. (@SGottliebFDA) 

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Value-based care at the heart of new guidances, and, as usual, they came with Gottlieb tweets.

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There’s already ample evidence that telemedicine has great potential for improving outcomes and saving patients and healthcare organizations money. Saving lives, however, is a different proposition.

But not all telehealth is direct-to-patient. Video counseling for providers can act as a force multiplier for medical knowledge. And according to researchers from University of Michigan Medical School and the Ann Arbor Veterans’ Affairs Medical Center, such peer-to-peer videoconferencing might have helped survival rates among a cohort of more than 62,000 patients with liver disease.

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focused on a program called SCAN-ECHO, which stands for Specialty Care Access Network-Extension of Community Healthcare Outcome. The original ECHO program is a 

videoconferencing program first developed in New Mexico

 that works to “upskill” physicians by connecting them with specialists to inform care of patients with unique needs (rather than connecting a patient directly with a doctor via video).

"Primary care providers really want to do the right thing, but they may not have all the necessary tools," Grace Su, MD, chief of gastroenterology at the VA Ann Arbor Healthcare System, said in a statement. "This research shows an excellent way to impart specialty knowledge to them. The learning is mutual. They are not just learning; they are teaching us."

The Ann Arbor VA was an early adopter of the SCAN-ECHO program, and was among the first to apply it for chronic liver disease. For Su, that’s personal—she was apparently motivated by the death of one of her patients which may have been preventable with specialist intervention. The area that surrounds Ann Arbor&mdash;central Michigan and Northern Ohio and Indiana&mdash;has large rural populations, which can make specialist access tricky. A program that passes those skills along to primary care physicians is especially appealing there.

The new research observed 5 years of clinical data from 62,237 veterans with liver disease in the region. Only 513 of them had a primary care physician participating in SCAN-ECHO. Physicians discussed their individual patient cases with the specialists, and then brought their conversations and advice back to their appointments. The individual cases likely to be discussed were those of younger veterans with more severe disease who also lived in rural areas.

Su said that the program creates, in a way, “mini-specialists.” And despite the extreme minority that patients treated by SCAN-ECHO physicians represented, they seemed to fare far better than the rest of the cohort even when adjusted for other variables: Based on the Cox Proportional Hazard Model, those patients had a 54% higher survival rate.

There are limitations to the study, of course: Participation was voluntary, which means the doctors who received video consultation might have had a more significant investment in learning and treating the condition at a higher level, but it was impossible to compare specifics with providers who did not participate. There’s also the matter of VA data, which recent examples have shown can be flawed or incomplete.

Still, the team is confident in the project and the new study, believing that the patients who participated exhibited better treatment habits than those who did not.

"It seems that primary care providers who participated in the SCAN-ECHO were more likely to follow the guidelines for cirrhosis and perform the screening for esophageal varicose veins and liver cancer in the patients who need it,” she said. "I think it is the behavior of the provider that's the reason patients lived longer."

The study complements the findings of one presented a year ago at an endocrinology meeting, which found that after months of ECHO-based “upskilling,” primary care providers reported far higher confidence levels in treating another key chronic disease—diabetes.

“What if instead of moving these patients into the diabetes specialty clinic, we move medical knowledge out to the underserved communities?” one of the University of New Mexico researchers behind that report asked at the time.

Speaking of the new study, Su essentially answered that query: "Our only other alternative is to send specialists to rural areas, and that's not going to happen,” 

, “video consultation is the future of medicine.”

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Not all telehealth is direct-to-patient. Video counseling for providers can be a force multiplier...and potentially, a life-saver.
 

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There’s a lot of theoretical applications for machine learning in healthcare, but almost as often as we hear about those, we see a new study outlining an actual, practical tool made possible by a series of smart algorithms. Adding to that ever-growing pile is a new tool that can predict hypotension—low blood pressure&mdash;in surgical patients as soon as 15 minutes before it sets in.

 was built atop nearly 550,000 minutes of surgical arterial waveform recordings from 1,334 patients’ records (which included more than 25,000 instances of hypotension). It required high-fidelity recordings, but from them it could extract more than 3,000 unique features per heartbeat, leading to millions of data points to base the algorithm on, according to 

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"We are using machine learning to identify which of these individual features, when they happen together and at the same time, predict hypotension," lead researcher Maxime Cannesson, MD, PhD, said in a statement. Cannesson is a professor of anesthesiology and vice chair for perioperative medicine at UCLA Medical Center.

Once developed, the algorithm was validated against more than 33,000 minutes of recordings from over 200 patients’ records, which featured about 1,900 instances of hypotension.

In validation, the technique did quite well: sensitivity and specificity were 88% and 87%, respectively, 15 minutes before a hypotensive event: They improved to 92% each at 5 minutes before onset.

"Physicians haven't had a way to predict hypotension during surgery, so they have to be reactive, and treat it immediately without any prior warning. Being able to predict hypotension would allow physicians to be proactive instead of reactive," Cannesson said.

The ability to predict hypotension during surgery might allow physicians to avoid potentially-fatal postoperative complications like heart attack or kidney injury, the researcher added.

And unlike many theorized machine learning interventions, this one is closer than many to becoming a clinical reality. A piece of software—Acumen Hypotension Prediction Index&mdash;containing the underlying algorithm has already been submitted to the FDA, 

. It is proprietary to devices made by Edwards Lifesciences—the device company behind the machine learning technique. It has already been approved for commercial use in Europe since 2016.

"Although future studies are needed to evaluate the real-time value of such algorithms in a broader set of clinical conditions and patients,” Cannesson said, the work “opens the door” to application of the technology on other physiological signals, like EKG readings for cardia arrhythmia or EEG measurements of brain function.

“It could lead to a whole new field of investigation in clinical and physiological sciences and reshape our understanding of human physiology,” 

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"It could lead to a whole new field of investigation in clinical and physiological sciences and reshape our understanding of human physiology." 

An Algorithm to Detect Low Blood Pressure During Surgery

The new Partnership for America’s Health Care Future has enormous reach. But what it will do remains unknown.

Healthcare is changing in countless ways: New technology is reshaping treatment and physician workflows; outside conglomerates are closely eyeballing the industry (and the money it generates); health systems are rapidly consolidating; insurers and retail pharmacies are comingling; and Washington, DC, still remains unsure of how to regulate and structure all of it.

No one is sure what the future holds, but some venerable industry groups announced last week that they would be joining forces to hopefully shape (or perhaps brace for) whatever may come.

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For a collaboration with such noteworthy members, the new Partnership for America’s Health Care Future (PAHCF) 

, and with few specifics. What we do know is that it contains America’s largest insurance industry trade group (America’s Health Insurance plans, or AHIP), the largest physician advocacy organization (the American Medical Association—the AMA), a sizable specialty group (American College of Radiology&mdash;ACR), and a number of other organizations (including the Healthcare Leadership Council and the Federation of American Hospitals).

Materials regarding the PAHCF are detail-sparse: On a page titled “The Issues” the group lists “Affordability”, “Options”, “Access”, “Quality”, and “Innovation” as its sole pursuits, each with a 1-sentence descriptor.

Erik Smith, a spokesman for PAHCF, went only a bit further. He told 

™ that the group would look for “commonsense solutions” around ideas like “strengthening employer-provided coverage enjoyed by more than 180 million Americans, protecting the health care safety net provided by Medicaid, maintaining Medicare for our nation's seniors, and stabilizing the individual market place.”

Smith called the new collaboration a “diverse, patient-focused organization,” although its representation is currently heavy on insurance, pharmaceutical, and provider trade groups.

While PAHCF’s mechanisms and stances remain relatively opaque, its influential member organizations could give it substantial reach—and it isn’t done growing. Smith said that the Partnership is currently focused on adding new members that are interested in “pragmatic solutions that protect and build on what works in our health care system and fixes what is not.”

The repeated emphasis on words like “pragmatic” and “commonsense” might be key: As Mike Stankiewicz of 

, a few of the industry giants who have agreed to join the PAHCF might have opposing viewpoints on important issues. Provider advocates and insurance industry trade groups don’t always align on the costs associated with one another’s services.

Many seem to agree on the need to control drug prices, including the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) which lobbies for the expansion of generic rights and biosimilar access. The Pharmaceutical Research and Manufacturers of America (PhRMA) was also announced as an initial member of the group.

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Baltimore-based therapeutics company Insilico Medicine announced today that it had closed a strategic funding round led by Shanghai-based healthcare technology investment giant WuXi.

Insilico specializes in using advanced artificial intelligence (AI) technologies to pinpoint targets for new drugs and theorize molecules that could be used against certain diseases. In particular, it’s focused on using generative adversarial networks (GAN) to find accurate, verifiable biomarkers. In a previous interview, Insilico Chief Operating Officer Qinsong Zhu told 

™ that their methodology could be an improvement on existing AI-powered drug discovery methods.

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“After we generate new molecules, we can focus on these few molecules instead of screening from hundreds and thousands compound as the traditional drug discovery methods,” 

 “In theory, the methodology could apply to any medical condition, as long as we could have enough training data.”

WuXi’s AppTec venture arm led the new funding round, with contributions from Pavilion Capital, BOLD Capital, and Juvenescence (which also has a treatment discovery arrangement with the company). The total value of the round has yet to be disclosed.

Insilico Medicine’s founder and CEO, Alex Zhavoronkov, praised his company’s new backers in 

. "WuXi AppTec is a leading global pharmaceutical and technology platform company and it has been a privilege to work hand-in-hand with WuXi AppTec's world-class chemists and biologists, who routinely solve some of the most complex challenges presented by the global pharmaceutical industry," he said.

The strategic pairing will also integrate Insilico’s efforts with WuXi AppTec’s laboratory infrastructure. Edward Hu, Chief Investment Officer at WuXi AppTec, said that his firm was impressed with the breadth of Insilico’s technological capabilities and applications, “ranging from target identification and small molecule generation using next-generation artificial intelligence to expertise in blockchain and aging research."

Insilico Medicine was born out of Johns Hopkins University’s Emerging Technology Centers, and has only existed as an independent company since 2014. Its previous 2 funding rounds raised a total of $14 million, and it has also forged a drug development partnership with American pharma company GlaxoSmithKline.

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The new partnership also calls for closer drug discovery collaboration between WuXi AppTec and Insilico Medicine.