On December 2, 2014, Illumina (NASDAQ:ILMN) and Sequenom (NASDAQ:SQNM) agreed to settle their patent disputes and collaborate instead of compete in NIPT. The intent was clear: Pooling over 450 patents to accelerate the global adoption of NIPT by licensing this IP and helping clinical labs bring testing in-house. The results of the collaboration so far can be seen in the remainder of this post.
|Other active licensees||3||4||8||10||16||23|
|Signed in period||NA||3||8||4||3||7|
|Activated in period||1||4||2||6||7|
|% prior pending||6%||22%||9%||25 %||33%|
Q4-14 Note: The active 3rd party licensees were LabCorp (NYSE:LH), LifeCodexx and Laboratoire Cerba. All three were active licensees prior to the IP Pool consummation. It's unclear how many licenses were pending at the time of the transaction.
Q1-15 Note: GeneTech in Japan was the new active licensee. Illumina reported signing 4 new licensees rather than the 3 noted in the table.
Q2-15 Note: Quest Diagnostics (NYSE:DGX) was the largest of the newly active licensees. The other three appear to be: American Hospital of Paris, Genea and Progenity.
Q3-15 Note: The two new activations appear to be SRL and BIrmingham Hosp UK.
Q4-15 Note: The six activations appear to be: Biomnis, Center for Human Genetics, Counsyl, Genoma, igenomics and Labco.
Q1-16 Note: The seven activations appear to be: Baylor Miraca, CGC Genetics, Mayo Clinic, Genesis, Recombine, Synapse and Victoria Clinic. In all periods, the activations are based upon information found in press releases, abstracts or websites and could include inaccurate assumptions.
Licensee Note: A licensee is believed to need to be authorized specifically (licensed) in each geographic region, but is only counted once in the licensee disclosures.
LabCorp of America
- Brand: informaSeq
- Locations OUS: LabCorp has international clinical labs in Canada, UAE and UK (10k). Their Covance acquisition also has lab services in Belgium, China, Japan, Singapore and Switzerland. References to informaSeq have been found in Brazil, Japan and Mexico markets. It's unclear if samples are being sent to US or processed locally.
- Volume: 136,633 through Feb 16, 2016
- Clinical Performance link here
- Brand: QNatal
- Locations OUS: Quest has international lab locations in Mexico, Puerto Rico and UK. They reference international operations in Belgium, Brazil, India, Ireland and Sweden. It's unclear if QNatal is being offered or processed in markets outside the US.
- Volume: The only volume information found is the Sequenom reference to their decline of 8,000 tests in Q2-15 from Quest activating.
- Brand: PrenaTest
- Locations: LifeCodexx is based in Germany. They have been very active signing with partners in many other markets on a test send-out basis. Link here
- Volume: The company claims that PrenaTest is ordered every 30 minutes. Link here
Syngen Group includes Labco
- Brand: neoBona
- Locations: neoBona was initially launched in Italy and Spain in Q1-16. The company product website shows availability in Brazil, Columbia, Italy, Portugal, Spain and the UK. Link here.
- Presence: The Synlab Group claims to be the uncontested EU leader in clinical lab services with a presence in 35 countries and 4 continents. Link here.
- Brand: No single brand at present. Verifi is used as test send out in certain markets. NIPT by Biomnis in France.
- M&A activities: Purchased Biomnis in France, NTD Labs in US and a majority owner of Emory Genetic Labs in US. Both Biomnis and Emory are licensees to the pool (Biomnis active).
- Locations: Eurofin states they have 225 labs in 39 countries on their website. Link here.
There has been a marked increase in website activity suggesting licensee activation. My current estimate is that over a dozen pending licensees have begun offering tests in-house this quarter. Review my tweets (@mchilberg) for specifics and links.
The stated objective of the IP Pool was to accelerate the adoption of NIPT and facilitate the process of transitioning test processing in-house by interested clinical labs. It that context the pool has gotten off to a strong start. Clinical labs appear to be preparing for accelerating adoption. The US market is ready for average risk with labs preparing to increase throughput by offering their own NIPT. Internationally NIPT is constrained by self-pay policies but that is starting to change. Germany and Switzerland have recently begun to provide reimbursement for both high and average risk pregnancies. NHS in the UK is beginning to cover for high risk pregnancies. Other markets will likely follow suit as price decreases and awareness increases stimulate action.
Disclosure: I am/we are long ILMN, SQNM.