Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Es­fand­yarpour holds what looks like a mi­ni-cool­er up to the com­put­er screen in his Cal­i­for­nia of­fice.

Es­fand­yarpour is in his late-30s, with crows feet creep­ing up against a youth­ful face. He wears a gray po­lo and the de­vice in his hand — with its hard plas­tic-look­ing shell, blue-and-white pat­tern, and a white plas­tic pad­dle re­sem­bling a han­dle jut­ting out the front — might con­tain diced straw­ber­ries and peanut-but­ter sand­wich­es to meet mom and the kids at a So­Cal park. In­stead, Es­fand­yarpour tells me it’s go­ing to change med­i­cine and bio­phar­ma re­search.

Hesaam Es­fand­yarpour

“Med­i­cine is bro­ken com­pared to oth­er tech­nol­o­gy,” he told End­points News. “It means a lot for bio­phar­ma…  it’s go­ing to make a big im­pact on what’s go­ing on with bi­ol­o­gy, both for the pa­tient se­lec­tion and it’s very im­por­tant for clin­i­cal tri­als.”

Es­fand­yarpour is the CEO and founder of Genap­sys, and the de­vice is his long-billed DNA se­quencer. It’s hooked up to the cloud and the white pad­dle ac­tu­al­ly con­tains a slot for a se­quenc­ing chip on which you place the DNA sam­ple.

Speak­ing at con­fer­ences, lec­ture halls, and to Face­book bil­lion­aire Yuri Mil­ner, Es­fand­yarpour has promised for sev­er­al years that the 9.5-pound de­vice will make DNA se­quenc­ing faster and cheap­er — an iPad was his com­mon point of com­par­i­son, al­though the launch prod­uct is larg­er — and thus ush­er med­i­cine in­to the big da­ta era. Now with $90 mil­lion in back­ing from Fore­site Cap­i­tal and oth­ers, that de­vice is hit­ting the mar­ket.

Es­fand­yarpour said di­ag­nos­tic and bio­phar­ma re­search labs have been high­ly in­ter­est­ed in the tech for its ca­pa­bil­i­ty and cost. But Kei­th Ro­bi­son, a com­pu­ta­tion­al bi­ol­o­gist for a Boston-based syn­thet­ic bio com­pa­ny, said that while Genap­sys may find in­ter­est from new biotechs, most sci­en­tists have been trained on Il­lu­mi­na. Com­pa­nies would face huge switch­ing costs.

“Is there a mar­ket for these rel­a­tive­ly small out­put se­quencers?” Ro­bi­son, who al­so runs the blog Omic­sOmics told End­points. “Il­lu­mi­na con­trols 90% of the se­quenc­ing mar­ket over­all, any­one try­ing to get in­to the mar­ket has to fight this gi­ant.”

Es­fand­yarpour’s back­ground is in elec­tri­cal en­gi­neer­ing and he’s been say­ing med­i­cine is bro­ken for some time now, telling Stan­ford stu­dents in 2017 “Steve Jobs claimed to be a prophet, I was in his re­li­gion” and “we can move atoms… but when it comes to med­i­cine we’re still in the cave age.” This area of med­i­cine, though, has been cor­nered and guard­ed for some time. Il­lu­mi­na now counts sales over $3.3 bil­lion per year and a mar­ket cap of $43 bil­lion. With an eye to­ward up­starts such as Nanopore and Ion Tor­rent, they’ve rolled out new prod­ucts such as their No­vaSeq $100 af­ford­able op­tion.

But Es­fand­yarpour says that’s $100 for a ser­vice from a mil­lion-dol­lar ma­chine (and doesn’t re­al­ly cost $100). Genap­sys’s de­vice comes at $9,900 — they mar­ket them­selves as “un­der $10,000” — and is all-in-one. You put the DNA on­to a se­quenc­ing chip made from su­per­con­duc­tors and slip the chip in­to the de­vice. The read­out takes about a day. Ac­cord­ing to Ro­bi­son, it en­ters as the cheap­est se­quencer on the mar­ket.

The ap­pli­ca­tions for cheap, road-trip-cool­er sized ge­nomics are wide and Es­fand­yarpour spoke about teas­ing out new can­cer tar­gets and rapid­ly test­ing pa­tients for clin­i­cal tri­als. Roche’s Foun­da­tion Med­i­cine es­ti­mates that de­spite ad­vance­ments in tar­get­ed on­col­o­gy, on­ly 15% of can­cer pa­tients get ad­vanced DNA se­quenc­ing.

Much of that tech al­ready ex­ists in some form, though, Ro­bi­son said. He thinks ul­ti­mate­ly there is room for Genap­sys to break in, but it will de­pend on how good the ear­ly edi­tions are. He re­called Nanopore get­ting blast­ed on Twit­ter when ear­ly ver­sions of their plat­form gave in­ac­cu­rate read­outs. The tech im­proved but the rep­u­ta­tion stuck.

“The thing prob­a­bly is re­al, but can they re­al­ly ex­e­cute?” Ro­bi­son said. “Does the thing work as it ad­ver­tised? When I get one, does it re­al­ly be­have or is it like an As Seen On TV thing?”


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Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

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Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.

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