Laboratories – the forgotten stakeholder | Diaceutics

Laboratories – the forgotten stakeholder


"Pathologists and laboratories are often overlooked as key stakeholders by pharma and this factor can have a considerable impact on the uptake of targeted therapies." This case study considers the role of laboratories in relation to uptake, including how a choice of technology can impact on laboratory test adoption, as the technology preferences of laboratories can vary considerably. "

1: Case Summary

This case will help you understand:

That laboratories are often the forgotten partners in the delivery of personalized therapies to physicians worldwide.

The impact that laboratories have on the uptake of targeted therapies.

How a choice of technology can impact on laboratory test adoption, as the technology preferences of laboratories can vary considerably.

Key messages:

In the US two major laboratory companies are used by the majority of doctors.

Outside the US the laboratory sector is highly fragmented.

Pathologists and laboratories are often overlooked as key stakeholders by pharma, which can have a considerable negative impact on the uptake of targeted therapies.

Multiple hidden hurdles exist when introducing new tests into the market.

Key actions:

Understand the laboratory as one of your key stakeholders.

Ensure the right number of right laboratories are 'ready to run' with the new diagnostic from the day of the launch.

Pharma should improve communication with laboratories about their companion diagnostics and protocols.

2: In the US, Two Major Laboratory Companies Are Used by the Majority of Doctors

So What?

Through a series of strategic acquisitions, the US has two major laboratory service providers that together reach more than 80 per cent of all physicians.

Commentary

The biggest commercial laboratory company in the US is STAT Labs, with a network of 1,200 regional laboratories. It offers all major molecular diagnostics via in-house and purchased kits.

3: The Laboratory Sector is Highly Fragmented Outside the US

So What?
The laboratory sector is highly fragmented outside the US with no single global player.

4: There is No Pan-European Laboratory Network

So What?
The EU does not have a dominant laboratory group or a pan-European network.

Labco is an example of group that was establishing a network but it has a limited market share in biomarker testing. It works with INCa in France which conducts all oncology biomarker testing.

5: In Japan, SRL Serves as a Sales and Marketing Representative for Some Foreign Clinical Laboratories

So What?
SRL (Special Reference Laboratories) is the largest commercial reference laboratory network in Japan, offering comprehensive clinical laboratory testing facilities focusing on highly complex tests, with extensive coverage throughout Japan. It operates testing mainly for hospitals, of which Japan has more than the US or any European country.
Commentary
Japan has more hospitals than the US or any European country and a growing diagnostics market. Its population is shrinking but its population of over 65s is higher and growing faster than other developed nations. Changes in the age demographic is causing significant changes in the make-up of the overall health care spend with a shift towards cardiovascular, musculoskeletal and endocrine disease.

6: Laboratories Often Overlooked as Key Stakeholders by Pharma...

Which is the most frequent way of implementing a new test in your service catalogue, according to your experience?

 %
The laboratory manager checks bibliography and decides to implement the appropriate determinations 64.5%
The first time you hear about a new test is from a physician, not the company 16.1%
Other way 12.9%
Pharma directly contacts the laboratory and explains the benefits 6.5%
  100%
So What?

Pathologists and laboratories are often overlooked as key stakeholders by pharma.

Pharma should improve communication about its diagnostics and protocols given that the incidence of pharma working directly with laboratories to introduce a new test is low.

7: …Which can have a Negative Impact on Targeted Therapy Uptake

Example: EGFRm testing in France

 
 
It’s good to know that INCa support EGFRm testing but the costs they cover are for the kits. I don’t see any of that money, but still I need additional staff to run those tests…
Molecular Lab Manager, Paris, 2011

 

 

8: Many Hidden Hurdles are Faced when Introducing New Tests to the Market

What are the issues you face when introducing a companion diagnostic?

 

 

So What?

Multiple complex issues arise when introducing a new diagnostic test. Comprehensive preparation is essential to gain early laboratory uptake.

9: The Time and Investment Needed to 'Make the Last Mile' is Often Underestimated by Pharma

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So What?

When launching a companion diagnostic program into the marketplace, ensure the right number of right labs are 'ready to run' with the new test from the day of the launch. Fast availability is the foundation of fast adoption.

10: In Europe, Pushing Fast Diagnostic IHC Adoption Through a Single Test is Challenging





EU labs using particular HER2 testing solution [2015]


  • Dako HercepTest: 19%
  • Ventana Pathway: 39%
  • Ventana Confirm: 16%
  • Leica: 3%
  • LDT (including those utilizing the Dako AB): 23%
So What?

In Europe, pushing fast diagnostic IHC adoption through a single test is challenging, as preferences of individual laboratories vary considerably.

When rolling out a new test it is important to consider the test technology.

11: Many EU Laboratories Have Never Purchased IVD Kits

 % of labs where LDT used% of labs where IVD kit is used
 Germany 60% 40%
France 50% 50%
UK 57% 43%
Spain 64% 36%
Italy 67% 33%
EU5 60% 40%

 (Note: Percentages can change massively between biomarkers)

 

So What?

To help understand the EU laboratory market, Labceutics completed a Delphi study of attitudes and behaviours in testing for personalized medicine and found that a considerable share of laboratories had never purchased IVD kits [2011].

Commentary

Labceutics surveyed 31 partner laboratories, in depth, of differing sizes and in five EU countries from September to December 2011, to determine barriers to new test adoption.

12: Is CE Marking or FDA/EMA Approval Important When Implementing a New Test in the Lab?

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(Scale of importance: 0 = not important, 5 = extremely important)
So What?

The launch of a diagnostic kit alone is not a big factor in most markets. Every new kit needs a business case before laboratories will embrace it.

However, FDA proposals for LDT regulation with an immediate focus on high risk tests, including CDx, could have an impact.

Commentary
While the FDA has always claimed it has the authority to regulate LDTs, it has long exercised 'enforcement discretion' over them. ​
The 2014 FDA Draft Guidance on LDTs proposes a risk-based regulatory framework. For Class II and Class III LDTs, or moderate- to high-risk tests, the FDA will phase in registration, listing, adverse events reporting, as well as 510K and PMA review requirements, over a nine-year period. ​

With increasing requirements associated with having FDA review and approval/clearance of companion diagnostic tests, laboratories may not develop such tests. Consequently, the broad availability of CDx tests to support Rx prescription may be reduced, leading to adoption of FDA-regulated manufactured IVDs.  ​

13: Key Messages

Key messages:

In the US two major laboratory companies are used by the majority of doctors.

Outside the US the laboratory sector is highly fragmented.

Pathologists and laboratories are often overlooked as key stakeholders by pharma, which can have a considerable negative impact on the uptake of targeted therapies.

Multiple hidden hurdles exist when introducing new tests into the market.

Key actions:

Understand the laboratory as one of your key stakeholders.

Ensure the right number of right laboratories are 'ready to run' with the new diagnostic from the day of the launch.

Pharma should improve communication with laboratories about their companion diagnostics and protocols.

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