PGX Sales – FAQs & Technical Due Diligence PGX Sales – FAQs for Beginning Partners

PGX Sales – FAQs & Technical Due Diligence

Are PGX plants GMO’s?

Because we are able to very significantly enhance the performance of plants across a wide range of parameters, the questions that inevitably arise are:

  1. “Is what you are doing Genetic Engineering (GE) or Genetic Modification (GM)?”; and
  2. “Are the plants you develop Genetically Modified Organisms (GMOs?”

The answer to both questions is “No, not by any definition!”

If Not GM or GE, Then What Are You Doing?

We are “doing” epigenetics.

We apply our understanding of epigenetics – “the study of changes in gene expression caused by mechanisms other than changes in the underlying DNA sequence, some of which are heritable[1]” – to stress plants in very specific ways so as to bring about targeted responses that will enhance their performance under a range of conditions.

One of the enhancements we commonly bring about in diploid plant species (those with two genomes per cell) is polyploidy (more than two genomes per cell) which, for plants under stress, is a particularly useful – and natural – enhancement.

What the Regulators Say

With respect to polyploidy, the European conventions on GMO state;

The following techniques are not considered to result in genetic modification, provided that they do not involve the use of hybrid DNA molecules or GMOs:

  • In vitro fertilisation.
  • Natural processes such as conjugation, transduction or transformation.
  • Polyploidy induction.”

PolyGenomX does not use “hybrid DNA molecules or GMOs” in its processes.  To do so would render what we do no more effective than all of the other failed attempts at polyploidy which exploit this or other intrusive or corruptive techniques.

By choosing the path we have, we are able to precisely modulate a whole-of-genome response to specific stressors, bring about the changes in gene expression we are seeking, retain complete genomic integrity, and enjoy heritability in the results.

The definition we apply to the word “polygenomic” is “a stable and fertile new polyploid variety induced by the application of the Lamont Process[2]”.

What the Experts Say

With respect to the epigenetic induction of abiotic stress tolerance and biotic stress resistance, in the words of one of the world’s leading agri-businesses, following “a rigorous process of review

of (PGX’s) underlying hypotheses” concluded, “the (PGX) technique is capable of permanently removing epigenetic suppression of genes for tolerance . . . based on the assumption that PolyGenomX technology affects epigenetic gene silencing and, therefore, is not trait specific but rather dependent on the ‘stress agent’ and its interaction with the plant (in intensity and duration) which induces native preservation mechanisms in the plant. Since this native plant reaction relies on genes present but silenced in the plant genome, we believe that PolyGenomX ability to induce resistance in a few cycles can be explained and trusted.

What the Law Says

In Australia, one of the most GMO-sensitive jurisdictions in the world, the matter of genetically modified organisms falls under the Gene Technology Act 2000.

With respect to that Act, the short answer from one of Australia’s leading IP Lawyers specialising plant molecular biology is, “No, PGX techniques do not amount to genetic engineering nor can PGX plants be considered as genetically engineered.  PGX plants are as “genetically modified” as those that have been cross-bred to obtain advantageous characteristics. Without inserting genes or extracting plant DNA, modifying it and reintroducing into the plant, what PGX is doing is conventional breeding and cross breeding, with perhaps certain steps (stresses) that may have an impact on the plant’s genome – but it is the plant itself that modifies the genome in response to external stimuli rather than there being any external genetic intervention.[3]

Will You Certify That Your Plants Are Not GMO?

In the words of the same IP lawyer, “It would be a retrograde step to set a precedent by providing such certification.  It certainly strikes me as unnecessary.”

To put that into context in the case of polygenomic food plants, for example, if we were to in some way “formally certify” that the polyploids we induce epigentically are “not GMO’s” then should the same be required of all the producers of those other polyploid foods, the ones that have occurred spontaneously in response to epigenetic stress in either Nature or in the course of being selectively bred, including:

·        Apples

·        bananas

·        cabbage

·        citrus

·        cotton[4]

·        ginger

·        kiwifruit

·        leek

·        oats

·        peanuts

·        potatoes

·        strawberries

·        sugarcane

·        triticale

·        watermelon

·        wheat

·        corn

·        strawberries

·        seedless watermelon




What We Say

Our Purpose from our foundation has been to develop science and technology which enhances the performance of plants for the benefit of humanity and in harmony with Nature.

As our knowledge of and ability with epigenetics has grown so has our confidence that it will deliver most of the promises made by GE and GM, but with none of the risk factors.

For the record: We interpret our commitment to working “in harmony with Nature” as precluding our use of Genetic Engineering and Genetic Modification techniques – for good!

[2] Malcolm Lamont is the Inventor of PGX’s Process and the Company’s Chief Scientist

[3] Ivan Rajkovic, Shelston IP Lawyers

[4] the oil is used in cooking and food production

How does your method for producing polyploidy differ and how is it better than other commonly used methods (i.e. colchicine oryzalin, trifluralin, amiprophos-methyl, and N2O gas, and other chemical doubling agents)

  1. Different? We cannot disclose the method beyond stating that we induce polyploidy in an entirely different manner to all of the “common” methods of which we are aware, nearly all of which have been around since the 1930’s.

The best proof of difference lies in our empirical evidence.  When compared to other polyploidy processes and their products, our process exhibits predictable and consistent results, and our plants demonstrate immediate and continuing superior performance with near complete genetic stability through successive seed-bred generations.

  1. Better?  The commonly-used approaches to inducing polyploidy provide their practitioners with very little control over outcomes.  Generally, using those approaches requires many replicants, the vast majority of which exhibit a range of negative cascading physiological problems.

Our approach provides an efficient, reliable, predictable, consistent beneficial outcome.

Are you able to control the ploidy level in advance, or do you need to screen the plants that were subjected to the treatment for a successful event?

Control? Yes, we can control the ploidy level in advance; and

Screening?  No,  we don’t need to screen the subjects to “find successes”.   Generally, it’s a one-on-one success process.

What is the efficiency of your method?

The efficiency (efficacy?) is 100%.  There can be slight variations on some clones but within the normal range of any biological system.  We sometimes take advantage of that normal variation by running the process two or three times each with slightly different parameters, each on different samples of the same genetics, to produce two or three events each of which produces a slightly different adjustment in the genome. Thus, we are able to rapidly and reliably “induce natural diversity”.

Some of our forestry clients have grasped – and taken advantage of – our ability to induce within the new polygenomic varieties we develop from their elite cultivars the types of diversity that they have previously invest decades in detecting, isolating, and developing.

How do you screen for a successful event, phenotypically and genotypically?

Both phenotypically and genotypically.

How do you analyse the polyploids for other mutations in the genome and for chromosomal aberrations?

We have the capacity to run AFLP’s at any time to check genetic consistency but experience has taught us that this generally a waste of resources.  If the process were to fail for any reason, the clones experience major physiological problems and simply do not pass our grosser screening processes.

Since the process evolved on its present foundation we have not experienced or seen evidence of any mutations (beyond natural and induced diversity) in any of our plants or progeny generated by any means.  Thus, in day-to-day production we do not invest in deep genetic analysis as there are no evidence it is warranted for either science or product quality control reasons.

In instances where we have focused on analysis of specific controls for characteristics such as wood density, fibre length, and general tissue quality, and have commissioned 3rd parties to examine diploid parent plants and their polyploid progeny at a deeper level for these,  there have been no indications of genetic mutation or physiological divergence beyond very normal limits.

Our standard testing regime includes (and we most commonly employ only the first two):

  1. Real-time leaf analysis for the rate of photosynthesis – polyploids show significantly increased rates compared to their diploid peers;
  2. Direct observation of stomata size and count, and a visual genome count;
  3. AFLP’s as and when required;
  4. Flow cytometry (though we see little current value for our purposes and seldom resort to it)

Based on your experience, how long would it take to produce a successful event in eucalyptus?

    1. Within the 743 Eucalypt varieties?
      1. Polyploidy:  Guaranteed in any variety; 10-14 months
      2. Environmental stress tolerance: 10-14 months
      3. Disease resistance: 10-14 months though at around double the standard project cost due to the requirement for extensive 3rd party-provided genetic profiling and subsequent in-house analysis.

Can you elaborate on the epigenetics concept?

We have developed a process which forces directed changes to the genome which affect a number of genetic components which include (but are not limited to):

polygenes which is a group of non-allelic genes that together influence a phenotypic trait;

  1. micro RNA;
  2. methylation patterns;
  3. the frequency and location within the genome of transposable elements.

                ii.          What is the rationale behind the approach?

  1. A plant, when stressed, will adapt or die.
  2. The 4 factors listed above control adaption to environmental stressors. While it has only recently become understood that epigenetic factors can account for up to 60% of change within the phenotypic characteristics of plants, Malcolm Lamont has been working on a day-to-day basis at this practical level with these principle for nearly 20 years.

                  i.          What are the results and how are they analysed?

  1. The consistent results are stable, fertile new polyploid varieties which exhibit much the same performance traits as their diploid parents, but with the increase in carbon efficiency, growth rate and yield associated with (natural) polyploidy.
  2. We have the capacity to “stack” the processes we use so that the new PGX plants’ induced traits may include polyploidy and/or environmental stress tolerance and/or disease resistance.  All of those traits are then heritable.
  3. When necessary we analyse adaptations using  transciptome assembly, 100bp paired ends, 30-40 million reads per sample.

What is the physiological explanation for your claims of faster growth, earlier maturation, higher and earlier yields, greater robustness and greater adaptability for your polyploids?

About 85% of plant species including cereal grains (wheat, rice, barley, oats) and most trees are designated “C3 plants” on the basis of their photosynthetic process and all share the disadvantage that their photosynthetic efficiency is only around 67% due to “photorespiration”.Photorespiration occurs when the plant inhales a CO2 molecule but cannot separate it to harvest the carbon atom for sugar formation. Instead, one time in three the plant will expend water, energy and time to “respire” a CO2 molecule without gain.Most diploid C3 plant species are subject to this phenomenon.  Polyploids[1] of those same species, however, do not suffer the same limitations and approach 100% efficiency in their harvesting of atmospheric carbon.  Thus, they harvest approximately 50% more carbon for exactly the same expenditure of energy as their diploid peers.Other physiological changes accompany natural or spontaneous polyploidy (gigantism of components, including fruits, seeds and leaves is common) which result in earlier maturation, higher yields, and general robustness including increased tolerance to biotic and abiotic stress.

This general robustness is different to  – but synergistic with – the epigenetically induced abiotic stress tolerance and biotic stress resistance that comprise separate and different applications of PGX’s technology.

[1] Ploidy is a count of cellular genomes.  Hence “diploid” (2n) designates a plant having two genomes (one “set”) per cell, and “polyploids” have more than two genomes (or one set).  In naturally occurring polyploids the genome counts are generally even (4n, 6n) and the plants are fertile.  Some polyploids, however, may have X-and-a-half sets” of genomes (eg, 3n, 5n) and will be sexually sterile (a common example being seedless watermelon).