The troponin proteins—cardiac troponin I and T—are the best biomarkers we have for determining whether there’s been damage to the heart. As many as 80% of patients who have had a heart attack will show an elevated level of cardiac troponin I in their blood within two to three hours of visiting the emergency room.
But while troponin—which is released when heart cells are damaged or die—is the most sensitive and specific marker we have for serious cardiac injury, could it also offer an early warning sign of such injury?
That has been the hope driving innovation in a slew of new assays that aim to measure troponin and a host of other telltale proteins—more on those in a bit—with extraordinary sensitivity. Ideally, if we could measure minuscule amounts of troponin in healthy individuals, we could also detect the most incremental changes in its level over time—and warn of heart failure or early ischemic disease when there is still time enough to slow or reverse it.
“Today, most of the technologies that can see proteins in blood can see disease, but they can’t see health,” says Kevin Hrusovsky, CEO and executive chairman of Quanterix, which makes an über-sensitive protein-detection machine called Simoa. “And that continuum is very important because if we can see any migration from baseline, and be able to detect things very early, we can see any trend away from health.”
Simoa works by putting 500,000 little antibody-connected beads into a sample of blood. The beads slosh around in the blood and when they bump into a specific type of protein, they connect to it like Velcro. Then Simoa tosses in a second antibody—this one tied to a fluorescent light—which gloms on to any bound protein-antibody complex from the first round. The beads are then rolled onto a Sony disc that has 212,000 little holes on it. The beads fall into the wells, which are just a tiny bit bigger, “like a bingo ball sliding into a bingo tray,” says Hrusovsky. Eventually, a laser camera scans every single well to see whether or not there’s a light on a given bead. Simoa can detect just one light on one bead in one well—which is to say a single target protein in a relative ocean of blood.
The technology is based on what’s called a “sandwich ELISA,” which isn’t new at all. ELISA (enzyme-linked immunosorbent assay) has been around for more than half a century. “We are using a very traditional ELISA test and just putting some—I call it some digital trickery—onto it,” says Hrusovsky. But what the Lexington, Mass., company has really done is to figure out how to do 500,000 tests in the same time we used to do one.
That’s hack No. 1. And while Quanterix—which was cofounded in 2007 by David Walt, cofounder of gene-sequencing biggie Illumina—is (slowly) developing a diagnostic test with French firm bioMérieux, it has made the smart move not to wait around for FDA approval, a process that can take years. In the meantime, Quanterix has gotten its $165,000 fridge-sized machine into pharma, biotech, and university laboratories across the globe—essentially letting other scientists prove its mettle and publish the results. Outside scientists have already tested the company’s assays for detecting protein biomarkers associated with concussion and traumatic brain injury, Alzheimer’s disease, various cancers, and the inflammatory process that is likely involved in several pathologies.
The strategy, you may recall, is a far cry from the black-box approach of Theranos (see Carreyrou, John, WSJ). This year, the privately held Quanterix, which is backed by Bain Capital Ventures, ARCH Venture Partners, and Flagship Ventures, among others, expects to pull in $19 million in revenue—without what Hrusovsky calls “regulatory or reimbursement risk.” That’s hack No. 2.
In the burgeoning age of digital health, it’s that second hack that entrepreneurs may want to take heed of.
More news below.
Google Ventures’ founder isn’t launching a massive new health care fund after all. Last week, Recode reported that Google Ventures founder and former CEO Bill Maris was gearing up to launch a new $230 million venture fund focusing on health care. But the Silicon Valley entrepreneur has apparently had a change of heart and won’t be setting up “Section 32,” as the project was slated to be named, after all. “[S]taring down the barrel of doing again exactly what I just did was not inspiring me, and I pulled the plug. Life is too short to not be true to yourself. I’m still taking time off and exploring some other ideas that may be more fun and impactful,” Maris wrote in an email to Recode last Friday. It was unclear exactly what Section 32 would have focused on (though there was a decent chance cancer and aging-related diseases would have been top priorities). Now, we’ll never know. (Recode, Fortune)
A new antibiotic may be headed for U.S. and EU markets. California biotech Achaogen shares soared 75% in early Monday trading after the firm announced that its new experimental antibiotic, plazomicin, is almost ready for marketing applications in the U.S. and Europe. Late-stage trials found that the candidate was comparable to meropenem, a wide-spectrum antibiotic that can be used on everything from urinary tract infections to sepsis to meningitis. While plazomicin wasn’t found to exceed meropenem’s capabilities by the FDA’s standards, even a new antibiotic that proves non-inferiority is significant given the rising tide of drug resistant bacteria, or “superbugs.” Public health officials have been sounding the alarm on the near-nonexistent pace of new antibiotic development, describing the threat of superbugs as a “ticking time bomb” that could wreak havoc across the globe if left unchecked. (Endpoints)
Can we change the color of fat to fight obesity? When it comes to fat, color makes a big difference. Now, scientists are probing whether or not it’s possible to actually trick white fat cells, which are meant for energy storage and comprised of unhealthy fats, into behaving like brown fat cells, which actually burn energy, as a way to fight obesity. And initial research from University of Pennsylvania scientists suggests that the tactic may actually hold some promise. A team of researchers targeted a specific pathway in the white fat cells that makes them take on the characteristics of their energy-burning, obesity-fighting counterparts. “It’s conceivable that one would be able to target this pathway with a drug, to push white fat to become brown fat and thereby treat obesity,” said senior study author Zoltan Arany in a statement. The method could also have implications in blood sugar and cholesterol maintenance. (FierceBiotech)
Alexion CEO and CFO depart in the midst of a sales fraud investigation. Alexion Pharma, a rare disease drug maker known for its top-selling Soliris, has initiated an executive shakeup in the midst of an internal investigation into the company’s sales practice. The firm announced that CEO David Hallal will be leaving for “personal reasons” (CFO Vikas Sinah is heading for the exits, too), and that Alexion board member and former AstraZeneca chief David Brennan will temporarily be taking over Hallal’s role. Alexion has been looking into allegations by a former employee that Soliris was being sold in a way that didn’t comply with company policies, although details are sparse, and the internal probe has forced the company to delay its most recent earnings report. Alexion shares fell 16% in early Monday trading. (Wall Street Journal)
Express Scripts finally relents, will cover Gilead’s hep C cure. Express Scripts, the largest pharmacy benefits manager in the U.S., made waves in 2014 when it refused to cover Gilead’s blockbuster, next-gen hepatitis C therapy Harvoni (which includes Sovaldi). The PBM instead opted for AbbVie’s competing Viekira Pak (which some analysts argued at the time wasn’t quite as effective as Gilead’s drugs), asserting that it had gotten a better deal from AbbVie. But Scripts is finally changing its tune and has decided to cover Harvoni on its 2017 formulary. That may not be too surprising—backlash from insurers and benefits managers (and plenty of public outrage on drug pricing) has forced Gilead to offer much steeper discounts since Sovaldi and Harvoni launched in 2013 and 2014, respectively. And Scripts appears intent to continue flexing its muscles when it comes to negotiations with drug makers, including by pushing a model that would set different prices for cancer drugs depending on which kind of cancers they’re being used to treat.
Ophthotech slammed after late-stage trial failure in wet AMD. Ophthotech was riding high after landing a $200 million upfront payment from pharma giant Novartis to test out whether or not its treatment Fovista could be used in tandem with Novartis’ mega-seller Lucentis to help eye disease patients see better. But the biotech’s shares crashed in Monday trading, plunging 85% after a combination of Fovista and Lucentis failed to help patients with the degenerative eye condition wet AMD see better than those treated with Lucentis alone. “We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD,” said Ophthotech CEO David Guyer in a statement. It’s unclear where the future of the company’s collaboration with Novartis stands.
THE BIG PICTURE
Big pharma is having a horrible December of job cuts. No less than five pharmaceutical giants have announced significant job cuts so far in December, as I report in my roundup of big pharma layoffs. The five involved firms? Mylan, Eli Lilly, Endo, AstraZeneca, and Sanofi. And the reasons behind the cuts run the gamut from the fallout of a major trial failure (Lilly) to sluggish sales of new drugs (Sanofi) to the waning popularity of flagship products like opioid painkillers (Endo). At this point, it seems that the biggest cuts will be at Mylan and Sanofi, which are planning to cut “under 10%” of its total global workforce and 20% of its U.S. diabetes sales crew, respectively. (Fortune)
Med schools to Donald Trump: Slow your roll on Obamacare repeal. The largest association of U.S. medical schools is joining insurers and hospitals in warning President-elect Donald Trump and the incoming Congress against dismantling Obamacare without coming up with plans for those who have gained health coverage under the law. “Recently insured patients with complex conditions require stability and continuity in their care. If the exchange marketplace is disrupted, their inability to afford other coverage could cause them to forego or delay necessary medical care,” said Association of American Medical Colleges CEO Dr. Darrell Kirch in a letter to the President-elect and members of Congress. Specifically, Kirch urged Congressional leaders to keep Obamacare’s significant expansion of the Medicaid program for the poor in place. (Fortune)
Entrepreneurs Take on Depression, by Laura Entis
Microsoft Plans to Back More AI Startups Through Venture Funding, by Aaron Pressman
Will Anyone from Silicon Valley Stand Up to Trump at His Tech Summit, by Mathew Ingram
|Produced by Sy Mukherjee|