INOVIQ Exosome Diagnostic Solutions
SubB2M | Go-to-market strategy
For personal use only
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SubB2M/CA15-3 test is expected to be partner-ready in December 2023 for
commercialisation as a Laboratory Developed Test
Build analytical
and clinical
validation data
package
Commercialise first
as an LDT in the USA
with a lab partner to
generate
early revenue
Complete IVD
medical device
development and
regulatory approval
via 510k / PMA
pathway
Secure IVD partners
and approvals
in major markets to
expand geographic
reach and grow
revenue
510k = FDA clearance for Class II device; CLIA = Clinical Laboratory Improvement Amendments (high-complexity tests); CMS = Centers for Medicare and Medicaid Services; IVD = In Vitro Diagnostic; FDA = US
Food & Drug Administration; LDT = Laboratory Developed Test; MDR = Medical Device Regulations; OC = Ovarian Cancer; PMA = FDA premarket approval for Class III device; KOL = Key Opinion Leader
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