The DNAscan System and the NDIS approval process

What . Why. How.

”What is Rapid DNA analysis?” ― https://www.youtube.com/watch?v=ggB2haS_AbM”Why is Rapid DNA analysis important?” ― https://www.youtube.com/watch?v=jcOGODelHhk”DNAScan NDIS approval. What does it mean?” - https://www.youtube.com/watch?v=mTRITOIgacA

1) Michigan Law Review, 1991. http://www.dnasaves.org/dna_law.php. Accessed March 2016.

DNAscan Rapid DNA Analysis System is for forensic and research use only. Not for use in diagnostic procedures. GE, GE monogram, and DNAscan are trademarks of General Electric Company. Rapid DNA Analysis is a trademark of NetBio. YouTube is a trademark of Google, Inc. All other third party trademarks are the property of their respective owners.

© 2016 General Electric Company ― First published April 2016.

All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request.Contact your local GE Healthcare representative for the most current information.GE Healthcare Bio-Sciences AB Björkgatan 30, 751 84 Uppsala, SwedenGE Healthcare Europe, GmbH Munzinger Strasse 5, D-79111 Freiburg, GermanyGE Healthcare UK Limited, Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UKGE Healthcare Bio-Sciences Corp., 100 Results Way, Marlborough, MA 01752 USAGE Healthcare Dharmacon, Inc., 2650 Crescent Dr, Lafayette, CO 80026 USAHyClone Laboratories, Inc., 925 W 1800 S, Logan, UT 84321 USAGE Healthcare Japan Corporation Sanken Bldg., 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073, Japan

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In March 2016,the DNAscan System became the first and only Rapid DNA system to be NDIS approved for use by accredited laboratory performing Rapid DNA Analysis.

Any Rapid DNA system that automatically generates CODIS-uploadableDNA profiles without human review has to be NDIS approved

Current NDIS-approved laboratory workflow

NDIS-approvedRapid DNA workflow

Rapid DNA – Swab in, CODIS profile out in < 90 min

Accredited labs completed a series of tests to demonstrate that the system is reliable, reproducible, and robust. The results were submitted to NDIS and considered for approval by a committee of experts.

GE Healthcare and our validation partners conducted extensive testing to ensure that the DNAscan Rapid DNA Analysis System will give law enforcement officers full trust and confidence in the system.

To receive NDIS approval, the entire Rapid DNA system must be tested and approved together.

The ability of the system to perform its required functions under stated conditions for a specified period of time.

The ability of the system to replicate the same results.

The ability of the system to perform without failure under a wide range of conditions.

Samples from a large number of unique donors were tested using Rapid DNA and compared to results generated by traditional laboratory methods.

Samples from the same donors were tested by different labs, using different instruments, batches of consumables, and operators and still generated identical results.

Samples from different people with a varying amounts of DNA generated approved DNA profiles, showing that the system can accommodate a varying quantity of input DNA.

DNAscan Rapid DNA Analysis SystemGE Healthcare Life Sciences offers the DNAscan Rapid DNA Analysis System, a fully automated rapid STR system with integrated data analysis and Expert System software that enables the processing of up to 5 different DNA sample swabs in less than 90 minutes.

What is an NDIS-approved Rapid DNA system?

An NDIS-approved Rapid DNA system must show

90 min

STR kits/chemistry

Instruments

Expert SystemSoftware

Rapid DNA system

NDIS

NDIS

NDIS

Sample

CODIS

NDIS-approved lab workflow

NDIS-approved Rapid DNA system

LDISLocal DNA

Index System

SDISState DNA

Index System

DNAscanTM System

NDISNational DNA Index System

Is my Rapid DNA system NDIS approved?

CODISCombined DNA Index System

In the US, 6% of criminals… …commit 70% of all crimes 1

These criminals could have been stopped earlier if a DNA match couldhave been done while the individuals were in custody.

With an NDIS approved Rapid DNA system law enforcement are able to search the DNA profiles in that national database and take action on matches, keeping criminals off the street while excluding innocent suspects.

NDIS approval is important because it allows the profile to be searched against the national database – a huge repository of DNA profiles. Searching against NDIS allows for the best opportunity for a match and reduces the chances of releasing a criminal.

Learn more about Rapid DNA on YouTubeTM:  

Reliability

Sample collectionTime: < 2 min

Sample shipmentTime: 48 h

BacklogTime: 2–14 days

Sample preparationTime: 1–3 h

Sample collectionTime: < 2 min

Sample preparationBioChipSetTM CassetteTime: < 2 min

DNAscan SystemTime: < 90 min

Set up assayTime: 0.5–2 h

PCR amplificationTime: 3.5 h

DetectionTime: 6 h

Analysis/interpretationTime: hours to days

Final resultTotal time: < 90 min

Final resultTotal time: 2–14 days

Reproducibility Robustness

Accuracy

Reproducibility

Sensitivity

Additional key studies

What is Rapid DNA analysis?

DNAScan NDIS approval. What does it mean?

Why is Rapid DNA analysis important?

Why is NDIS approval important?

How is NDIS approval secured?

Blank swabsThere must be no cross-contamination during the DNA process. If a blank swab is put in the DNAscan System, no DNA profile should be generated.

InhibitorsThe DNAscan System must generate DNA profiles from cheek swabs even when people had recently chewed gum, smoked a cigarette, or eaten.

MixtureThe DNAscan System must identify and flag any DNA profiles containing DNA from more than one person.

SpeciesThe system must only generate results from human DNA, and the presence of DNA from other species (e.g. dogs, cats, monkeys) does not interfere with the result.

StabilityDNA profiles can be generated even if the swab isn’t tested immediately after collection. When properly stored, samples can be stored for a period of time without any impact on the quality of the results.

< 90 min

2-14 days

NDIS

NDIS

NDIS