Firm works on can­cer di­ag­no­sis

Northwest Arkansas Democrat-Gazette - - FRONT PAGE - EMMA N. HURT

A com­pany in Spring­dale is work­ing to rev­o­lu­tion­ize the de­tec­tion of breast can­cer with an un­usual sub­stance — tears.

The team at As­cen­dant Dx has de­vel­oped a test an­a­lyz­ing tears that could com­ple­ment — or even re­place — mam­mo­grams as the first step in look­ing for breast can­cer.

Omid Moghadam, CEO and chair­man, said that in

mid­dle- to lower-in­come coun­tries with­out the fund­ing or ex­per­tise to op­er­ate mam­mog­ra­phy on a large scale, As­cen­dant’s Melody test would be a game changer.

“We think that bi­o­log­i­cal tests like Melody would be per­fect for that en­vi­ron­ment,” he said of their prod­uct, which de­tects biomark­ers found in tears to test for the dis­ease within 30 min­utes.

“It’s in­ex­pen­sive, ac­cu­rate and some­one with min­i­mal train­ing can run it.” From there, he ex­plained, pa­tients who test pos­i­tive can travel to larger med­i­cal cen­ters for fur­ther test­ing and treat­ment.

To­day, physi­cians are re­im­bursed through med­i­cal in­surance be­tween $250-$350 per mam­mo­gram, while As­cen­dant’s tar­get re­tail price for Melody is $99.

In places like the U.S., which has $5 tril­lion worth of mam­mog­ra­phy equip­ment, there is also a lot of room for im­prove­ment, he said.

“In the U.S. we are still brute forc­ing breast can­cer de­tec­tion with mam­mog­ra­phy, be­cause we had noth­ing un­til 30 years ago,” he said.

“When you go from not hav­ing any­thing to some­thing that is 50 per­cent ac­cu­rate, that’s what takes hold. And that’s what we still have to­day: a not-so-good imag­ing tech­nique that has 50 per­cent false pos­i­tive, 50 per­cent false neg­a­tive.”

Dr. Suzanne Klim­berg is a breast surgeon at the Univer­sity of Arkansas for Med­i­cal Sciences’ Rock­e­feller Can­cer In­sti­tute who pi­o­neered As­cen­dant’s re­search. She re­mains the com­pany’s med­i­cal di­rec­tor and said early de­tec­tion of breast can­cer is the best thing un­til a pre­ven­tion or cure is found.

“Ac­cess to care has been the big­gest stum­bling block,” Klim­berg said. “My dream has al­ways been to have this on the mar­ket and, sim­i­lar to the use of a preg­nancy test, be able to screen your­self.”

Moghadam re­ferred to a study by Mei-Sing Ong and Ken­neth Mandl in Health Af­fairs jour­nal that found that of the $8 bil­lion a year spent on mam­mog­ra­phy, $4 bil­lion is wasted on false-pos­i­tive di­ag­noses.

Among Amer­i­can women, breast can­cer re­mains the second-most-di­ag­nosed can­cer and the second-most-com­mon cause of can­cer death.

The As­cen­dant story starts in 2006 with Klim­berg at UAMS. She was in­spired to work with hu­man tears af­ter see­ing re­search on de­tect­ing the can­cer in breast milk, real­iz­ing that the tis­sues that con­cen­trate blood to pro­duce both flu­ids are sim­i­lar.

“It’s an un­usual fluid, but it has ben­e­fits,” Moghadam said of tears.

“It’s ster­ile, and it’s a lot less com­pli­cated than blood,” he said. “Blood has so many bits and pieces of cells and DNA that any­time you want to look for some­thing, you have to fil­ter lots of things out in or­der to find them. That be­comes ex­pen­sive.”

The TRG Foun­da­tion in Lit­tle Rock funded Klim­berg’s ini­tial re­search, and then it caught the at­ten­tion of the VIC Tech­nol­ogy Ven­ture De­vel­op­ment, a Fayet­teville ven­ture cre­ation com­pany. That’s where, Moghadam be­came in­volved, and in 2013, when it spun out of VIC, he be­came its CEO.

Dr. Steven Harms, a breast ra­di­ol­o­gist at the Breast Cen­ter in Fayet­teville, said he was orig­i­nally skep­ti­cal of the idea.

“At first I thought, ‘This is very in­ter­est­ing, but I don’t think it is go­ing to work.’ I was very skep­ti­cal, be­cause it’s al­most too good to be true.”

In the end, the re­sults won him over. He now serves on the com­pany’s board, and the Breast Cen­ter has par­tic­i­pated in the com­pany’s stud­ies.

He re­called that two of his pa­tients’ tra­di­tional biop­sies came back neg­a­tive but their As­cen­dant’s Melody tests came back pos­i­tive. At first they dubbed those false pos­i­tives, un­til the pa­tients re­turned a few months later with can­cer­ous biop­sies.

He said some­day, a test like Melody has the po­ten­tial to re­place mam­mo­grams as the first step in the process, though there will al­ways need to be an imag­ing method like mam­mog­ra­phy to lo­cate where the can­cer is.

“Wouldn’t it be nice if we could have peo­ple come in with a high prob­a­bil­ity of hav­ing can­cer in the be­gin­ning and con­cen­trate our re­sources on find­ing that can­cer in­stead of just screen­ing ev­ery­body?” he said.

Plus, he pointed out, only half of Amer­i­can women above 40 ac­tu­ally get mam­mo­grams for rea­sons like cost, dis­com­fort and geo­graphic ac­cess — things that Melody could over­come.

As­cen­dant has col­lected around 700 sam­ples from three val­i­da­tion stud­ies so far. Their next step is a clin­i­cal trial with 1,000 more sub­jects to gain reg­u­la­tory ap­proval in the U.S. and abroad.

One chal­lenge they face is be­cause no large-scale banks of tear sam­ples ex­ist, they have had to man­u­ally gather all their own sam­ples, un­like blood sam­ples, which can be pur­chased on large scales.

“Blood is al­ready op­ti­mized,” said Lind­say Ruther­ford, As­cen­dant’s se­nior sci­en­tist. “Ev­ery­thing has been de­ter­mined al­ready: how to take it, how to process it.”

As­cen­dant’s sci­en­tists have been op­ti­miz­ing their own tear pro­cesses as they go.

They use Schirmer’s test strips to col­lect sam­ples, which en­tails plac­ing a small piece of fil­ter pa­per un­der an eye­lid for about two min­utes. It ir­ri­tates the eye enough to pro­duce tears though has no last­ing ef­fects. They were orig­i­nally de­vel­oped by an oph­thal­mol­o­gist to mea­sure tear pro­duc­tion.

“It makes per­fect sense,” said Kevin Clark, CEO of NOW Di­ag­nos­tics, a Spring­dale com­pany that leases lab and of­fice space to As­cen­dant.

“I had not per­son­ally thought about it be­fore, but tears are part of the lymph sys­tem. Me­tas­ta­siz­ing tu­mors and ev­ery­thing show up in the lymph sys­tem, which is part of the im­mune sys­tem.”

NOW pro­duces tests that use a pin­prick of blood to gen­er­ate fast di­ag­nos­tic re­sults for a grow­ing list of things, in­clud­ing preg­nancy and in­fec­tious dis­eases. As­cen­dant is us­ing NOW’s car­tridges to house their Melody test.

He said he has high hopes for other things that could be de­tected by As­cen­dant’s tech­nol­ogy. “Es­pe­cially if we can put it in our plat­form, then you get a point of care de­vice that gives pa­tients real-time re­sults,” he said.

In the mean­time, As­cen­dant has patent ap­pli­ca­tions pend­ing in the U.S. and abroad, and is in the process of rais­ing a second round of fund­ing, be­yond the $2 mil­lion raised in 2013.

While tens of mil­lions of dol­lars have been poured into the breast can­cer cause, Moghadam said, “It just goes to re­search. You get nice papers, but where is the re­sult? Where is the new drug? Where’s the new di­ag­nos­tic? Where’s the new method? Where’s the new med­i­cal de­vice?”

He called this a “fun­da­men­tal” prob­lem in the in­dus­try, not just for breast can­cer. Re­searchers are in­cen­tivized to pub­lish papers, but there is a gap be­tween those papers and trans­lat­ing them into prod­ucts.

“This is re­search with a pur­pose for us,” said Anna Daily, As­cen­dant’s chief sci­en­tist, point­ing out that in academia there is lit­tle qual­ity con­trol or ver­i­fi­ca­tion of re­sults.

By con­trast, she ex­plained, “When you’re in a busi­ness or a com­pany, you have to prove to your in­vestors, the FDA and other reg­u­la­tory or­ga­ni­za­tions that we did what we said we did and it shows what we said it showed.”

“They build build­ings but in re­al­ity, no­body needs an­other $50 mil­lion build­ing on a cam­pus,” Moghadam said.

“What you need is $50 mil­lion go­ing into 10 com­pa­nies, and if one of them is suc­cess­ful it can ac­tu­ally ma­te­ri­ally af­fect peo­ple with breast can­cer.”

Ul­ti­mately, he said, “If peo­ple re­ally, truly want to cure can­cer, there needs to be a bal­ance be­tween re­search and trans­lat­ing re­search into real prod­ucts.”

NWA Demo­crat-Gazette/DAVID GOTTSCHALK

Anna Daily, chief sci­en­tist at As­cen­dant Dx, places a strip in the eye of se­nior sci­en­tist Lind­say Ruther­ford. The strip ir­ri­tates the eye enough to pro­duce tears, which are then tested for signs of breast can­cer.

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