How will labs use expanded molecular testing capacities post-COVID-19?




, How will labs use expanded molecular testing capacities post-COVID-19?

With COVID-19 vaccinations starting this week within the US, the nation is coming into a brand new stage of the pandemic that would finally finish in widespread suppression of the virus.

The implications of this improvement for the lab business aren’t fully clear, however after virtually a yr spent constructing out molecular capacities to fulfill COVID-19 take a look at demand, the query of what to do with that capability in a post-COVID-19 atmosphere looms on the horizon.

In keeping with knowledge from income cycle administration and lab informatics agency Xifin, throughout the lab business as a complete, as of Dec. 12, 2020, complete testing volumes had been 245 % of baseline testing volumes, with round 55 % of that quantity COVID-19 molecular testing. Whereas molecular testing labs have led the best way, with volumes at 538 % of baseline (and 79 % of that quantity because of COVID-19 molecular testing), all different segments of the enterprise are additionally nicely above baseline, with pathology, medical, hospital, and toxicology lab volumes at, respectively, 143 %, 226 %, 218 %, and 267 % of common baselines.

Most business gamers recommended that the introduction of vaccines is unlikely to affect COVID-19 testing volumes within the close to time period and that demand would proceed to be excessive for at the least the following six months and doubtlessly into 2022.

Long term, although, laboratories and platform producers will possible be in search of methods to both shed molecular testing capability or discover new assessments to place it in direction of.

“If individuals have taken on new platforms to do giant volumes of molecular testing and people volumes are a lot larger than any testing they ever did earlier than, that gear might be not going to have a whole lot of use in that setting [post-COVID-19], and you will have to make some exhausting selections about whether or not you need to do away with it or the way you would possibly attempt to repurpose it,” mentioned Robert Boorstein, medical director at Brooklyn-based Lenco Diagnostic Laboratory.
Having extra gear available is not essentially a foul factor, Boorstein mentioned, nevertheless it does include prices when it comes to service contracts and lab area. He added that if labs have bought new gear with potential menus past COVID, they might transition to these new platforms and retire older ones.

“Nevertheless, if somebody has purchased gear to do lots of of hundreds of molecular assessments monthly and their regular quantity is 200 genetic assessments monthly, their infrastructure simply is not going to assist that,” within the absence of COVID-19 testing demand, he mentioned.

Donna Hochberg, companion with Newtown, Massachusetts-based healthcare consulting agency Well being Advances, mentioned that one possible consequence of the latest molecular take a look at capability buildout could be to speed up the uptake throughout the medical microbiology lab of molecular strategies, a pattern that was ongoing even earlier than the pandemic.

“What [labs] actually see taking place is that this accelerating the change from culture-based strategies to molecular-based strategies to the extent that that’s potential with the applied sciences that they’ve,” she mentioned.

She famous, although, that whereas this transition would make use of a number of the molecular capability on the market, “it is definitely not wherever close to being a blockbuster software for lots of labs that’s going to fill a whole lot of capability.”

“It’s going to assist, nevertheless it is not going to be the answer,” she mentioned. “You are going to want some new content material for that.”
Boorstein recommended that lots of the smaller hospital labs that when despatched out a lot of their molecular testing to both a bigger hospital or reference lab might now resolve to maintain that work in home.

“Numerous small and mid-sized hospitals may need had very restricted molecular menus — perhaps a point-of-care flu take a look at and a MRSA take a look at,” he mentioned. “But when they now have [a new molecular instrument] that they fought exhausting to get and are paying for, they might put [tests they previously sent out] on that instrument.”

Jane Hermansen, supervisor of outreach and community improvement at Mayo Clinic Laboratories, agreed that many labs that added molecular capabilities to deal with COVID-19 would hold it post-pandemic.

“Hospital labs, pathology labs which have by no means even considered being molecular laboratories previously now have the gear, and the gear is simpler sufficient to run that you do not have to have all of the particular capabilities you wanted within the previous days to truly have a molecular take a look at menu,” she mentioned.

Hermansen added that her friends within the hospital reference lab world reported that instrument distributors had been discussing with them the right way to use the molecular platforms they’d taken on in the course of the pandemic.

“Distributors are already working very intently with their shoppers to say, ‘OK, as we speak your capability is tied up with COVID, however what are you sending out, and what can we really slot in, when it comes to reagents, with the intention to now do these send-out assessments in home?,'” she mentioned.

Hochberg mentioned that whereas it wasn’t but clear what molecular purposes would possibly assist fill the capability that might be left as soon as the pandemic recedes, the lab business’s investments in constructing its molecular testing capability had given IVD producers an inflow of money that she anticipated they’d put partially in direction of new take a look at improvement.

“An entire lot of corporations have cash they didn’t anticipate, and it’s massive greenback values,” she mentioned, citing the instance of a small IVD maker she follows that noticed annual revenues bounce this yr from round $5 million to greater than $100 million.

“Large and small corporations which have gotten this COVID enhance, our learn is that they’re beginning to consider what they will do subsequent,” she mentioned. “And I feel pushing in direction of innovation and new content material is basically what they’re going for, and I feel that’s what’s going to find yourself utilizing that capability.”

Hochberg mentioned she did not anticipate such innovation could be adequate to make full use of present molecular testing capability, however she mentioned that she anticipated the inflow of funds would assist the business “push by means of some innovation in some several types of assessments and a few novel content material that it may not in any other case have been capable of put money into or which may have taken for much longer to push ahead.”

She mentioned she anticipated these efforts could be put each in direction of additional filling out infectious illness testing menus and in increasing into areas like oncology and neurological and autoimmune situations.

Boorstein recommended that the molecular capability overhang may not be as massive as present take a look at volumes counsel on condition that many labs are operating at a tempo far exceeding what they’d in regular occasions.

“Most of our enhance [in volume] has come by simply going from 5 shifts every week to shut to 20 shifts every week,” he mentioned. “We have considerably elevated capability by rising the productiveness of our present devices.”
Hermansen equally famous that at Mayo a lot of the capability enhance has been pushed by operating devices across the clock versus the everyday one-and-a-half or two shifts per day.

“Though we have now made some investments in gear, I do not see it laying fallow,” she mentioned. 
Boorstein added that given COVID-19 testing volumes labs have in lots of instances already recouped the prices of the brand new molecular instrumentation they bought for the pandemic.

Considerably trickier, he famous, are present selections round buying new instrumentation.

“I feel the issue might be, if individuals at the moment are taking a look at techniques… and [vendors] aren’t capable of ship parts for eight weeks, so it might be exhausting to think about being dwell with it inside three months,” he mentioned. “So what occurs if you happen to enter into this contract and three months from now your volumes fall off a cliff? I feel lots of people are afraid of this being a recreation of musical chairs, and so they would be the ones left standing, having made commitments to purchase gear.”

Hochberg mentioned a technique she is seeing labs deal with this concern is by choosing reagent rental agreements versus buying instrumentation outright.

“Fairly truthfully … I haven’t got the reply,” mentioned Jon Cohen, govt chairman of Opko Well being’s BioReference Laboratories, concerning what his lab deliberate to do with the molecular capability it had constructed as much as deal with the COVID-19 pandemic. He famous that whereas the lab provides quite a lot of molecular infectious illness assessments, it already had adequate capability for this testing previous to the pandemic.

“There’s an opportunity that we might need to keep [the capacity] and be ready if there may be the rest that comes down the road,” he mentioned. “I feel in all probability that dialogue will occur sooner or later, however I am definitely not ready to have that dialogue but. There’s an excessive amount of else occurring.”
LabCorp declined a request for an interview however famous in an announcement that it anticipated continued demand for COVID-19 testing throughout and following rollout of the vaccine.

Quest Diagnostics spokesperson Kimberly Gorode mentioned in an announcement that even with vaccinations beginning the corporate anticipated COVID-19 testing “will proceed to be important to medical care and public well being response for a while to come back,” and that Quest was persevering with to develop testing capability to take care of the continuing surge in COVID-19 instances.

She added that firstly of the pandemic the corporate ramped up COVID-19 testing capability partially by repurposing molecular testing gear already in use for different sorts of testing reminiscent of viral load testing for HIV and HCV.

“We’re taking a look at alternatives to additional leverage the scope of those platforms sooner or later,” she mentioned.

This story first appeared in Fashionable Healthcare’s sister publication GenomeWeb.