About 20 years in the past, a sure green-juice-loving tech mogul satisfied the world {that a} single drop of blood processed inside an inscrutable black field dubbed Edison can be the revolution of diagnostics. However while Theranos was crashing and burning, one other biotech firm was constructing one thing a little bit completely different, and much more wise. It entails your interval.
The Q-pad is an ingenious interval pad that lets individuals who menstruate acquire their menstrual blood from the consolation of their very own house and get examined for quite a lot of ailments like pre-diabetes and diabetes, thyroid well being, anemia, fertility and perimenopause, and cervical most cancers, which may presently solely be detected by way of a reasonably invasive pap take a look at. It was authorized by the FDA earlier this month, however not earlier than going by way of over 1,000 design iterations (with the assistance of a menstruating robotic named Betty.) Now, it’s on sale in the U.S. at an identical value level as a typical blood take a look at ($49 for a pack of two.)
The Q-pad is the brainchild of Dr. Sara Naseri and her biotechnology analysis firm Qvin (pronounced kwin and derived from the phrase “lady” in Danish.) It really works precisely like a daily interval pad, besides it additionally comes with a translucent oval that permits you to know you’ve collected sufficient blood for diagnostic functions, and a little bit tab that you simply pull to take away a paper strip. You then place the strip in a set machine earlier than mailing it to your clinic, which may take a look at it and share outcomes on an app or through e mail. “We needed to guarantee that for ladies dealing with it, it was a easy and never a messy expertise,” says Naseri. “You gained’t see any dripping or something like that.”
[Image: Qvin]
In 1986, NIH established a coverage that inspired researchers to incorporate ladies in research, however it wasn’t till 1993 that the coverage grew to become the legislation. “We’re behind, fairly frankly, on the data that now we have, and what’s actually upsetting is that even in circumstances that primarily have an effect on ladies, they’re studied on male biology,” says Naseri, whose purpose is to shut the gender hole and provides ladies a possibility to not solely perceive what’s happening with their our bodies but in addition be preventative about their healthcare.
A eureka second
Naseri was nonetheless in med college when it dawned on her: ladies bleed each month, why has no one used that blood for diagnostic functions? “You’re bleeding anyway,” she informed me.
That was in 2013. On the time, there was just one paper she may discover on the topic; it was revealed by a forensic division primarily based on a homicide case involving dried menstrual blood. However Naseri suspected there was medical utility to menstrual blood, so she got down to show it. She enrolled in Stanford College College of Drugs, based Qvin in 2014, revealed her first paper in 2016, and proceeded to run greater than 15 medical trials.
What she discovered was astonishing: menstrual blood has about 400 distinctive biomarkers. That’s nonetheless lower than half of the variety of biomarkers present in veinous blood—as within the blood that comes out of your veins. However as Naseri factors out, that’s 400 markers we by no means knew existed in menstrual blood.
A few of these biomarkers will also be present in veinous blood (wherein case the Q-pad turns into a matter of comfort), however others are distinctive to menstrual blood. That’s the case for cervical most cancers, which resides within the uterus, the place blood flows by way of when an individual is menstruating.
In 2020, cervical most cancers killed more than 340,000 women globally and Naseri says it’s solely preventable if we display for it. “It’s fascinating as a result of it actually removes a barrier to entry for healthcare once I don’t must drive into the physician’s workplace and get a poked with a needle,” she says. “I can, from the consolation of my own residence, acquire a blood pattern that may be a legitimate blood pattern that may inform me details about my well being.”
Designing a brand new diagnostic course of
The Q-pad is the fruits of 10 years of analysis and about seven years of design iteration. Why so lengthy? For one, ladies don’t menstruate on a regular basis, and it may be onerous to foretell when that may occur. The excessive variety of variables made it tough for the group to iterate on the product, and impressed them to construct Betty, a menstruating robotic that Naseri jokily refers to as “a giant member our of group.”
Betty’s curious silhouette revolves round a pair of panties with a interval pad strapped round a bicycle seat. One motorized arm pushes down on the seat, whereas one other tilts it forwards and backwards to simulate varied stress sorts and circulate charges. All of this occurs whereas an extended tube dispenses blood from a blood bag into the interval pad—just like the horror-movie model of an IV drip. Betty helped the group iterate till they discovered a dependable design that would acquire blood whatever the circulate charge. As soon as that was solved, they began testing on actual ladies. (No offense to Betty.)
Naseri says she tried “each modality” of blood interval assortment, together with menstrual cups, however ultimately settled on the interval pad as a result of individuals who menstruate are already aware of the expertise of it. A pad additionally maintains the integrity of the blood in a manner a menstrual cup may not, partly as a result of it comes with a floor space that’s sufficiently big for an built-in paper strip.
That’s to not say Qvin will cease at pads. “I do suppose that the expertise we’ve constructed might be utilized in different female hygiene merchandise,” she says, citing a number of patents for different methods of gathering blood: “The Q-pad is the primary, however possibly there will probably be a Q-pon.”
