ERP Micro December 2019

Table 21: GENE-UP ™ LMO Assay, Candidate h vs. Reference – POD Results (METHOD DEVELOPER) (1) Matrix/Test Portion Strain Time Point MPN a / Test Portion N b

Candidate-Alternative Conf

Reference

dPOD C f

95% CI g

x c

POD C d

95% CI

X 0

POD R e

95% CI

-

5

0

0.00

0.00, 0.43

0.00

0.00, 0.43

0.00

-0.43, 0.43

0.37 (0.24, 0.80) 4.38 (2.35, 11.15)

Deli Ham (25 g)

BMX 1 10432 1/2b

20

13

0.65

0.43, 0.82

9

0.45

0.26, 0.66

0.20

-0.10, 0.46

22 hours

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Candidate-Traditional Conf

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

0.37 (0.24, 0.80) 4.38 (2.35, 11.15)

Deli Ham (25 g)

BMX 1 10432 1/2b

20

8

0.40

0.22, 0.62

9

0.45

0.26, 0.66

-0.05

-0.33, 0.24

22 hours

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

1.38 (0.64, 1.75) 1.38 (0.69, 1.88)

Deli Ham (125 g)

BMX 10432 ½b

20

11

0.55

0.34, 0.74

14

0.70

0.48, 0.85

-0.15

-0.41, 0.14

24 hours

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

0.75 (0.53, 1.40) 2.43 (0.89, 4.38)

Deli Roast Beef (25 g)

BMX 10433 1/2a

20

15

0.75

0.53, 0.89

12

0.60

0.39, 0.78

0.15

-0.13, 0.40

22 hours

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

0.45 (0.33, 1.02) >10 (2.00, >10)

Deli Turkey (25 g)

BMX 10434 1/2a

20

10

0.50

0.30, 0.70

9

0.45

0.26, 0.66

0.05

-0.24, 0.33

22 hours

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43