Dx Launch Risks | Diaceutics

Dx Launch Risks


This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker's market progress, but to an entire company. It will help you understand:
  • How a risk management strategy for recalls should be agreed upon with the diagnostic partners
  • That no biomarker is immune to a potential recall
  • How a recall can be disruptive, not just for a test but the company as a whole
Download this case study to learn more.

1: Case Summary

This case will help you understand:

How a risk management strategy for recalls should be agreed upon with the diagnostic partners.

That no biomarker is immune to a potential recall.

How a recall can be disruptive, not just for a test but the company as a whole.

Key messages:

Since 2010 there have been on average three instances of personalized medicine-associated diagnostic devices recalls, up from one a year between 2000 and 2010. 

Dako, Ventana, Roche, Leica, Life Technologies and Illumina all experienced at least one recall from 2010.

Pharma teams should remain vigilant about the ongoing dialogue its partner is having with the FDA, in order to avoid surprises and interruptions to test supply.

Key actions:

Discuss with your partners and agree on a plan to avoid and overcome possible recall issues.

2: Recall Strategy

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So What?

Although recalls are rare, a risk management strategy should be agreed upon with the diagnostic partners.

Since 2010 there have been on average three instances of personalized medicine-associated diagnostic device recalls, up from one a year between 2000 and 2010. New players to the CDx market need to be extra cautious and integrate the risks associated with a potential recall into the CDx design process.

Commentary

The Food and Drug Administration (FDA) doesn’t often recall diagnostic tests once they have been approved, but the risk does exist, making it important to establish a strategy for managing that risk with the diagnostic partner.

A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Over the last decade, the FDA has only recalled one test per year on average, but it is nonetheless important to choose a diagnostic partner who can and will respond swiftly to any stoppage of supply. For example, DiaDexus, a small US-based company with only one product on the market, was recently required to inform customers of an issue connected with falsely elevated test results, which may have led doctors to intensify therapy such as statins.

Recall of a medical device does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted or fixed.

3: Even Long-Established CDx for Well Understood Biomarkers are Not Immune to Recalls (1)

So What?

During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but passed the 6 month stability testing. The kit is labelled for 9 months' shelf life stability.

4: Even Long-Established CDx for Well Understood Biomarkers are Not Immune to Recalls (2)

So What?

Dako, Ventana, Roche, Leica, Life Technologies and Illumina all experienced at least one recall from 2010.

Commentary

Dako had to recall its HER2 test in 2014 after it found abnormally low signal levels in the read-outs. Dako initiated a recall of HER2 CISH pharmDxTM Kit, Code SK109, Lot 20000910, because weak red signals had been observed.

5: Regulation of Dx Causes Uncertainty in Personalized Medicine

So What?

Lower costs for gene sequencing led to the advent of direct-to-consumer products.

The FDA fell behind as it could only regulate types of products that were already on the market.

The Google-backed 23andMe, which claims to be motivated by a desire for the data-driven, social network-linked and networked future of medicine, caused a lot of controversy.

Commentary

2008: dialogue starts between 23andMe and the FDA
2010: FDA notifies several genetic testing companies, including 23andMe, that their genetic tests are considered medical devices and require approval
2012: applications for FDA clearance in July and September 2012
2013: FDA orders 23andMe to stop marketing its $99 Saliva Collection Kit and Personal Genome Service (PGS) as the company had not demonstrated it had "analytically or clinically validated the PGS for its intended uses" and the "FDA is concerned about the public health consequences of inaccurate results from the PGS device". 23andMe stops advertising and providing interpretation of results but continues with ancestry-related data.
2014: approved for health-related results in the UK and Canada
2015: approved in the US only to determine Bloom syndrome risk

6: Partner Management Strategy

So What?

Pharma teams should remain vigilant about the ongoing dialogue its partner is having with the FDA, in order to avoid surprises and interruptions to the test supply.

Commentary

Although diagnostic recalls are rare, they can have serious consequences for the pharmaceutical partner, in the form of disruptions to test supply.

On November 2, 1999, the Department of Justice, on behalf of the Food and Drug Administration (FDA), entered into a consent decree of permanent injunction with Abbott Laboratories’ diagnostic devices division, which was not fully lifted until 2003. The FDA said Abbott had failed to comply with the Good Manufacturing Practices (GMP) regulation, (now called the Quality System regulation), and then did not correct its deficiencies.

The failures the FDA cited went back to 1993, when its inspection of Abbott’s diagnostic manufacturing facilities first showed that the company had failed to comply with the GMP in process validation, corrective and preventive action and production and process controls. The company’s failure to comply with the requirements increased the likelihood that the diagnostic products produced at Abbott’s facilities might not perform as intended, the FDA said.

The FDA said subsequent inspections showed little improvement, despite three warning letters. Ultimately, in order to protect the public health, it sought action by the Department of Justice.

7: A Deadly ‘Class I’ Recall Tag may be Deadly for the Company

So What?

Atossa’s shares have fallen roughly 60 per cent following the recall in October 2013 of its ForeCYTE test and have not recovered to date. The company is working on bringing it back to the market but has not yet succeeded.

Not having FDA-approval prior to marketing is a very bad idea.

8: Key Messages

Key messages:

Since 2010 there have been on average three instances of personalized medicine-associated diagnostic devices recalls, up from one a year between 2000 and 2010. 

Dako, Ventana, Roche, Leica, Life Technologies and Illumina all experienced at least one recall from 2010.

Pharma teams should remain vigilant about the ongoing dialogue its partner is having with the FDA, in order to avoid surprises and interruptions to test supply.

Key actions:

Discuss with your partners and agree on a plan to avoid and overcome possible recall issues.

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