We will soon be implementing minor modifications to the MycoSEQ™ Mycoplasma Detection Kits. These changes will:

  • Help lessen the kits’ impact on the environment
  • Simplify the ordering process
  • Strengthen the supply chain

1. Manufacturing raw material source change

As part of our ongoing effort to provide the highest quality mycoplasma detection products, the AmpliTaq Gold® DNA polymerase enzyme originally manufactured by Roche will transition to direct manufacturing by Thermo Fisher Scientific.

After performing rigorous internal comparability studies, the AmpliTaq Gold® DNA polymerase enzyme manufactured at our facilities was found to be functionally equivalent to the Roche-manufactured material. Several of our other products, including some in regulated markets, underwent a similar transition in 2012 and 2013 with successful results.

The decision to transition this raw material to in-house manufacturing was taken as part of an effort to improve control over our raw materials supply, produce the highest quality components, and help meet the supply demands of our customers.

In order to demonstrate the functional equivalence of the material manufactured by Roche and our in-house AmpliTaq Gold® DNA polymerase enzyme, a validation study specific to the MycoSEQ™ Mycoplasma Kit was also performed. This study concluded that MycoSEQ™ Mycoplasma Detection Kits and the polymerase enzyme manufactured by Roche are functionally equivalent.

Key points from the MycoSEQ™ kit validation report for this change include:

  • The in-house manufactured polymerase possesses an extremely low background Ct value that is experimentally indistinguishable from the Roche material, indicating that our manufactured polymerase is highly pure.
  • Ct for negative control 38.36 38.67
  • MycoSEQ™ assay formulated with both our in-house and the Roche enzyme delivered nearly indistinguishable Ct, Tm and Dv values, indicating that the two products will deliver the same present and absent calls for mycoplasma.
  • In-house enzyme Roche enzyme
    Ct 31.7 31.8
    Tm (°C) 84.2 84.1
    Dv 5.8 5.3

Individual laboratories, of course, should assess their requirements for implementation based on their procedures.

To support you through the transition and help ensure a smooth and seamless conversion, we will be providing access to a limited number of MycoSEQ™ Mycoplasma Detection Kits with our in-house enzyme for those customers who may require additional testing from May 18 through September 1, 2014. These kits will be identified through specific lot numbers.

The final validation report will be available upon request by May 18, 2014, or earlier.

This change applies only to the AmpliTaq® or AmpliTaq Gold® components of the MycoSEQ® Mycoplasma Detection Kits. Pricing will not change as a result of this transition.

2. Discontinuation of printed manuals and inclusion of the discriminatory positive control in all kit configurations

In an effort to help lessen our impact on the environment and provide easier access to product information, all MycoSEQ™ kit technical manuals will be made available exclusively online starting September 1, 2014. Electronic manuals save paper and provide features not available with printed manuals, such as a hyperlinked tables of contents, search tools, and useful links.

In addition, all kits will be reconfigured to include the MycoSEQ™ Discriminatory Positive Control (Cat. No. 4445000) with discontinuation of the MycoSEQ™ Mycoplasma Real-Time PCR DNA Control (Cat. No. 4384677).

The MycoSEQ™ Discriminatory Positive Control (Cat. No. 4445000) is a second-generation mycoplasma control that offers important technical advantages over the first generation MycoSEQ™ Mycoplasma Real-Time PCR DNA Control (Cat. No. 4384677). The MycoSEQ™ Discriminatory Positive Control DNA allows positive qPCR controls to be run with a greatly reduced risk of producing a false positive.

Without the unique properties of the discriminatory positive control, minor pipetting errors may produce positive results that are indistinguishable from a true mycoplasma positive result, and may trigger an unnecessary escalation in response. In addition, the signature qPCR signal of the discriminatory positive control has been integrated into AccuSEQ® 2.0 Real-Time PCR Software to enable rapid, reliable, and automatic detection of these events.

Implementation of these two changes greatly reduces the number of required MycoSEQ™ catalog numbers. With discontinuation of the printed manuals and inclusion of the discriminatory positive control in all kits, six of the current eight catalog numbers will no longer be necessary, and will therefore be discontinued. Please note that only configurations made unnecessary by removal of printed manuals and inclusion of the discriminatory positive control will be discontinued. The MycoSEQ™ product itself will, of course, continue to be manufactured and made available.

3. Actions required by you

For future orders, please use either:

Cat. No. 4460623: MycoSEQ™ Mycoplasma Detection Kit with Discriminatory Positive Control
or
Cat. No. 4460626: MycoSEQ™ Mycoplasma Detection Kit with Discriminatory Positive Control & sample preparation

If you’re currently using either of the catalog numbers above, then no change in ordering is required.

All other MycoSEQ™ Mycoplasma kit part numbers will be discontinued on September 1, 2014 (catalog numbers 4399363, 4407876, 4460625, 4460627, 4384772 and PN4409732).



MycoSEQ™ Mycoplasma validation kits containing the in-house manufactured enzyme will be available starting May 18, 2014 (or earlier) and through September 1, 2014 on a limited basis for comparability experiments. These validation kits will be identified through specific lot numbers, so if you wish to order them prior to September 1, please consult your sales representative. After September 1, stock of the current version of the MycoSEQ™ Mycoplasma kits will be exhausted, and no further batches containing the Roche components will be manufactured. All future batches of these kits will contain components manufactured in-house.

If you have questions or concerns not addressed below, or would like further information, please contact your local support or sales representative.

Please register below to receive the MycoSEQ™ transition validation summary report.

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A. As part of our ongoing efforts to provide the highest quality of mycoplasma detection products, Life Technologies is making minor modifications to the MycoSEQ™ Mycoplasma Detection Kits:

  • The DNA polymerase used as a component of the MycoSEQ™ Power SYBR® Green PCR Master Mix will transition from AmpliTaq® Gold Low DNA (LD) DNA polymerase, 5U/mL manufactured by Roche Molecular Systems Inc. (PN 4369569) will transition to AmpliTaq® Gold Ultra Pure (UP) polymerase 5U/mL manufactured in-house (PN 4474626).
  • Printed manuals will transition from printed to electronic form, available at www.lifetechnologies.com
  • The volume of RNAse (component PN 4405890) will be increased from 2 mL to 3 mL.
  • The Mycoplasma Discriminatory Positive Control, previously sold as a separate part, will be bundled with all MycoSEQ™ Mycoplasma Detection Kits.
  • The transition to on-line product literature and inclusion of the discriminatory positive control allows the number of MycoSEQ™ Mycoplasma Kit configurations to be reduced from eight to two:
    • MycoSEQ™ Mycoplasma Detection Kit (PN 4460623)
    • MycoSEQ™ Mycoplasma Detection Kit with sample preparation (PN 4460626)
All other MycoSEQ™ kit part numbers will be discontinued because their configuration is no longer required. These part numbers include PN 4399363, PN 4407876, PN 4460625, PN 4460627, PN 4384772, and PN4409732. Note that discontinuation of these PNs is only a simplification of the part number system and that the MycoSEQ™ Mycoplasma Detection Kit will, of course, continue to be manufactured.
A: The decision to transition the AmpliTaq Gold® raw material to in-house manufacturing was taken as part of an effort to improve control over our raw materials supply, produce the highest quality components, and help meet the supply demands of our customers. Both the AmpliTaq® and AmpliTaq Gold® enzyme manufactured by Life Technologies are established raw materials currently used in multiple product lines, including the resDNASEQ®, ViralSEQ®, and MicroSEQ® ID product lines.

A: An internal validation study comparing the AmpliTaq Gold® manufactured by Life Technologies and Roche within the MycoSEQ™ kit concluded that the two were functionally equivalent.

A: As the change does not impact the performance of MycoSEQ™ Mycoplasma Kits, there should be no impact on the validated state of the MycoSEQ™ method. We have performed a rigorous internal validation study that demonstrates functional equivalence between AmpliTaq Gold® manufactured by Life Technologies and that manufactured by Roche. However, if your regulatory assessment requires internal verification to be necessary, we will have validation lots available for you to perform your own comparative testing. Please contact your local MycoSEQ™ Mycoplasma Detection Kit representative for additional information.

A: Validation lots containing in-house manufactured AmpliTaq Gold(R) Ultra Pure enzyme will be available for order by May 18, 2014. These updated MycoSEQ™ Mycoplasma Detection Kits will incorporate all of the changes described in Question 1 of this document. Currently, we anticipate this transition process to span 5 months, from May to September. During this time, kits containing the current configuration and updated configuration will both be available.

A: Stock of the current configuration of the kits containing the Roche AmpliTaq Gold® will be maintained until September 1, 2014. This is to allow individual laboratories time to complete their implementation requirements before obsolescence of the current kits.

A: No pricing changes will occur due to updating of the MycoSEQ™ Mycoplasma Kit, as described in Question #1.

A: To support laboratories through the transition and help ensure a smooth and seamless conversion, we will be providing the following:
  • Communication of lot numbers, allowing you to specify an order for the current version of the kit or the new configuration of the kit (new configuration contains all changes described in Question #1)
  • Stock of both the current and new version of the kits will be maintained from May 18 to September 1, 2014.
  • An internal validation report demonstrating functional equivalence of kits that contain the Roche and Life Technologies manufactured AmpliTaq Gold® polymerases will be made available by May 18th 2014.