Health ex­perts main­tain that the cur­rent mon­key­pox sit­u­a­tion is a stark con­trast to Covid. Even so, a hand­ful of biotechs have sprung to ac­tion, in­clud­ing Roche, who quick­ly de­vel­oped a set of three tests to de­tect the virus.

Roche and sub­sidiary TIB Mol­bi­ol un­veiled their Light­mix Mod­u­lar Virus test kits on Wednes­day — three unique test kits that can help track the spread of mon­key­pox.

The first kit de­tects or­thopoxvirus­es, in­clud­ing all mon­key­pox virus­es orig­i­nat­ing from the West African and Cen­tral African forms of the virus. The sec­ond kit is a spe­cif­ic test that de­tects mon­key­pox virus­es on­ly, while the third si­mul­ta­ne­ous­ly tests for both or­thopoxvirus­es and mon­key­pox virus­es.

Thomas Schi­neck­er

“Di­ag­nos­tic tools are cru­cial for re­spond­ing to and ul­ti­mate­ly con­trol­ling emerg­ing pub­lic health chal­lenges as they ad­vance re­sponse mea­sures such as trac­ing ef­forts and treat­ment strate­gies,” Roche Di­ag­nos­tics CEO Thomas Schi­neck­er said in a state­ment.

The test kits are now avail­able for re­search use in most coun­tries around the world, ac­cord­ing to Roche.

Mon­key­pox has been around since 1958 when two out­breaks oc­curred in colonies of re­search mon­keys. Around 20 coun­tries have re­port­ed re­cent out­breaks, with cas­es pil­ing up main­ly in Eu­rope, ac­cord­ing to a Reuters re­port. The US con­firmed its first case in Mass­a­chu­setts just last week, and the CDC is in­ves­ti­gat­ing sev­er­al oth­er po­ten­tial cas­es.

BAR­DA said last week it would shell out $119 mil­lion in an agree­ment with Bavar­i­an Nordic to ex­er­cise op­tions for a freeze-dried stock­pile of Jyn­neos, which cov­ers both mon­key­pox and small­pox. And to­day, the com­pa­ny an­nounced it se­cured an­oth­er vac­cine deal with an undis­closed coun­try.

The Dan­ish com­pa­ny’s stock $BVN­RY was up more than 10% on Wednes­day af­ter­noon, pric­ing in at $9.65 per share.

Mean­while, Emer­gent snagged the rights to Tem­bexa, Chimerix’s small­pox treat­ment for all ages that was ap­proved in 2021. And Mod­er­na is test­ing its own vac­cine can­di­date in pre­clin­i­cal stud­ies, ac­cord­ing to Reuters.

Nor­man Bay­lor

Ear­li­er this week, Bel­gium be­came the first coun­try to in­sti­tute a manda­to­ry quar­an­tine pe­ri­od of 21 days for con­firmed mon­key­pox pa­tients.

This wouldn’t be the first time that the US has faced a mon­key­pox out­break. Cas­es cropped up in 2003 af­ter the US re­ceived a ship­ment of an­i­mals from Ghana. That out­break was con­tained with test­ing and vac­ci­na­tion, ac­cord­ing to the CDC.

Nor­man Bay­lor, who once di­rect­ed the FDA’s Of­fice of Vac­cines Re­search and Re­view and now serves as a con­sul­tant, told End­points News that he doubts the US will need to roll out wide­spread vac­cines. And he em­pha­sized that the sit­u­a­tion now is much dif­fer­ent than when Covid-19 ar­rived in the US back in 2020.

“The good news is we have a vac­cine. Re­mem­ber with Covid, we had noth­ing. We were start­ing from scratch,” he said.

In the US, mon­key­pox cas­es are con­firmed by or­thopoxvirus test­ing, which re­quires a dry le­sion swab spec­i­men ac­cord­ing to the CDC. Sam­ples are col­lect­ed by vig­or­ous­ly brush­ing a pa­tient’s le­sions, which are then sent to a net­work of lab­o­ra­to­ries for test­ing.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”